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Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Breaking News: Link 151

 

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We need to grow 50% more food yet agriculture causes climate change. How do we get out of this bind? 

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3 Reasons Why Women are Key to the Future of Global Health and Development 

Management of Latent Infection to End the TB Epidemic

Persons with LTBI (latent tuberculosis infection) have no signs or symptoms and are not contagious; however, they are at risk of progression from latency to active disease. On average, this happens in 5-10% of those affected during their lifetime, but some (“at-risk”) populations have a substantially higher risk of progression than the average. Hence, diagnosis and treatment of LTBI may represent an attractive strategy for TB prevention 

by Giorgia Sulis, Lucia Urbinati, Alberto Matteelli        

 Division of Infectious and Tropical Diseases – WHO Collaborating Centre for “TB/HIV co-infection and for TB elimination”, University of Brescia, Brescia, Italy

Management of Latent Infection to End the TB Epidemic

 

Latent tuberculosis infection (LTBI) is a condition in which TB bacteria (M. tuberculosis) survive in the body in a dormant state. In 1999 it was calculated that one third of the world population has LTBI (1), providing an estimate of the huge magnitude of the human reservoir of M. tuberculosis.

Persons with LTBI have no signs or symptoms and are not contagious; however, they are at risk of progression from latency to active disease. On average, this happens in 5-10% of those affected during their lifetime, but some (“at-risk”) populations have a substantially higher risk of progression than the average (2). Hence, diagnosis and treatment of LTBI may represent an attractive strategy for TB prevention. Historically, diagnosis and treatment of LTBI did not attract interest for TB control, as diagnosis and treatment of active TB is a more direct intervention to reduce transmission and incidence of the disease. However, the benefits of treating LTBI for individuals with high risk of progression (e.g. those with HIV infection) are well known since decades; moreover, in low TB incidence countries (i.e. 10 cases per 100,000 population or lower) it is now recognized that further decrease of incidence, and eventually TB elimination, will not be possible without addressing LTBI.

From a programmatic perspective, and under a public health approach, the management of LTBI stands on three main components: i) identifying those who should be tested, ii) defining the testing algorithm, and iii) the relevant treatment options. In addition, several supportive interventions need to be put in place, from involving multiple services of the health system, to ensuring sustained procurement of diagnostics and drugs, to setting up a manageable recording and reporting system for effective monitoring and evaluation.

According to the World Health Organization (WHO) policies, all people living with HIV (PLHIV) and children under 5 years of age who are household or close contacts of a TB case should be systematically assessed and treated for LTBI, given their extremely high risk of disease progression. Testing is not required for PLHIV, but it is encouraged whenever possible, based on the use of TST (tuberculin skin test) and limiting treatment to those with a positive test (3). In children, however, testing is not recommended. In both groups, LTBI treatment should be offered as soon as active TB is safely excluded. A 6-month regimen of isoniazid (300 mg daily in PLHIV; 10 mg/kg per day, range 7-15 mg/kg, with a maximum dose of 300 mg/day in children) is the mainstay of treatment in resource constrained countries; lifelong (approximated to 36 months) isoniazid treatment is conditionally recommended for PLHIV in areas with a high TB/HIV-burden, to account for the large risk of reinfection (3, 4). Unfortunately, LTBI management in these populations is either a poorly implemented intervention (5) or a fully neglected area (6), due to low political commitment and the limited availability of financial and material resources hindering implementation on a large scale.

The new END-TB strategy aims at changing radically this picture. By including LTBI management among the essential components of its biomedical interventions, and by setting a global indicator on coverage of LTBI treatment initiation in the above-mentioned groups, the strategy claims for a key role for this intervention on a global scale (7).

In high and upper-middle income countries with TB incidence below 100 per 100,000 population a substantial proportion of new TB cases are due to progression from recent or remote LTBI (2). In this setting TB elimination is stated as a realistic target within 2050 (8), and a list of eight priority actions has been proposed, including systematic screening and treatment of LTBI. WHO issued a guidance document for a public health approach to LTBI management in this context in 2014 (9).

Several at-risk populations, in addition to PLHIV and child contacts were strongly recommended for systematic testing and treatment of LTBI in this setting. These include persons with silicosis and those requiring treatment with tumour necrosis factor-alfa inhibitors, solid organ or bone marrow transplantation, or haemodialysis. For other risk groups, like prisoners, homeless people, injection drug users, migrants originating from high-TB burden areas, and health care workers, the decision to embark in LTBI testing and treatment should be taken locally based on prevailing epidemiology and resource availability (9). Candidates to treatment should be identified through immunological tests such as tuberculin skin tests (i.e. Mantoux test) and IGRAs (Interferon-gamma Release Assays) and those who yield a positive result should be systematically offered treatment, after exclusion of active TB. In such a context, treatment options go beyond isoniazid, and include short-course rifamycin-based regimens which may favour good patient adherence: 3 months of weekly rifapentine plus isoniazid; 3 months of daily rifampicin plus isoniazid; 4 months of daily rifampicin alone (9).

The existence of two different policies for rich and resource-constrained countries might look embarrassing. However, it stands on solid scientific basis. LTBI testing and treatment, even when considered under a public health perspective, must provide more potential benefits than potential harms to each single individual who is candidate to treatment. Wherever TB transmission is intense (high TB-burden countries) the occurrence of reinfections hampers the durability of LTBI treatment and significantly reduces the benefits, while the harms remain the same. Wherever resources are limited, LTBI activities cannot compete, in terms of cost-effectiveness, with diagnosis and care of active TB, since treatment of LTBI has an indirect effect on incidence.

The END-TB strategy has set a target of 90% LTBI treatment coverage (among PLHIV and children under five) within 2025: this may look unrealistic (7). Indeed, national TB Programs or their equivalent at ministerial level must face an incredible challenge as they virtually start from scratch in terms of LTBI testing and treatment interventions. Nevertheless, this very ambitious target can have a pulling effect on activities implementation and bring us close to the final goal, provided that substantial investment will be made in human resources and infrastructures.

 

References

  1. Dye C, Scheele S, Dolin P, Pathania V, Raviglione MC. Consensus statement. Global burden of tuberculosis: estimated incidence, prevalence, and mortality by country. WHO Global Surveillance and Monitoring Project. JAMA. 1999;282(7):677-86.
  2. Getahun H, Matteelli A, Chaisson RE, Raviglione M. Latent Mycobacterium tuberculosis infection. N Engl J Med. 2015;372(22):2127-35.
  3. Intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained settings. Geneva: World Health Organization 2011.
  4. Guidance for national tuberculosis programmes on the management of tuberculosis in children. Geneva: World Health Organization, 2014.
  5. Global Tuberculosis Report 2014. Geneva: World Health Organization, 2014.
  6. Acosta CD, Rusovich V, Harries AD, Ahmedov S, van den Boom M, Dara M. A new roadmap for childhood tuberculosis. Lancet Glob Health. 2014;2(1):e15-7.
  7. Uplekar M, Weil D, Lonnroth K, Jaramillo E, Lienhardt C, Dias HM, et al. WHO’s new end TB strategy. Lancet. 2015;385(9979):1799-801.
  8. Lonnroth K, Migliori GB, Abubakar I, D’Ambrosio L, de Vries G, Diel R, et al. Towards tuberculosis elimination: an action framework for low-incidence countries. Eur Respir J. 2015;45(4):928-52.
  9. Guidelines on the Management of Latent Tuberculosis Infection. Geneva: World Health Organization 2015.; 2015.

 

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Giorgia Sulis (Resident in Infectious Diseases since August 2013), was born in Italy in 1986. After graduating from the University of Pavia as a medical doctor in July 2011, she earned a postgraduate research fellowship on HIV/AIDS infection among migrants at the University of Brescia. She also holds a diploma in tropical medicine and international health with TropEd accreditation issued by the University of Brescia in 2013. In 2014 she performed an internship at the Global Tuberculosis Programme of the World Health Organization in Geneva, working with the TB/HIV team.

Lucia Urbinati was born in Italy in 1982. After graduating from the University of Bologna as a medical doctor, she attended a TropEd Course in Tropical Medicine and International Health held in Brescia. In June 2014 she completed her residency training in Tropical Medicine at University of Pavia. She is currently research fellow at the University of Brescia.

Alberto Matteelli was born in Italy in 1960. After graduating from the University of Pavia as a medical doctor he got his first job as WHO Junior Professional Officer in 1988 to work in Tanzania. He is employed by the Spedali Civili di Brescia since 1991. Currently he is the head of the Community Infections Unit, head of the Hospital STI centre, and co-Director of the WHO collaborating Center for TB/HIV co-infection.

Breaking News: Link 150

Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Breaking News: Link 150

 

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European Union and FAO launch new programmes to boost food and nutrition security, sustainable agriculture and resilience 

UNAIDS 2015: ORAL PRE-EXPOSURE PROPHYLAXIS QUESTIONS AND ANSWERS 

No Ordinary Free Trade Agreements – Health and the New Generation Trade Agreements

...from health policy priorities perspective, the more systemic danger of TTIP is that it could hinder necessary change of corporate profiteering and an already failing model for innovation and R&D towards pharmaceutical policy in the public interest...

Meri Koivusalo

by Meri Koivusalo*

Senior Researcher on Health Policy
National Institute for Health and Welfare
Helsinki

No Ordinary Free Trade Agreements  – Health and the New Generation Trade Agreements

 

The new generation trade agreements, such as the TPP (Trans-Pacific Partnership) and TTIP (Transatlantic Trade and Investment Partnership), have changed the ground and context of trade negotiations through extension of negotiations further to national policies and regulation. These new generation trade agreements have gained criticism not only from activists, but also from international and US economists (Krugman 2015, Summers 2015, Stiglitz 2015).

What has been made clear is that these are no ordinary free trade agreements. In Europe and in particular in European Union focus remains, perhaps unsurprisingly, dominated by trade and export opportunities. This is reflected, for example, in the number of references to EU- South Korea FTA as an example of prospective benefits from a trade agreement (Malmström 2015a):

We know that trade agreements do bring benefits. Since the EU-South Korea free trade agreement entered into force in 2011 our exports are up by 35%. In some sectors, like cars, they are up by 90%.”

On the other hand TTIP remains promoted explicitly due to the assumed benefits for global standard-setting at a higher-level. The European Union trade policy materials make the point that:

Aligning EU and US standards and regulations would mean exporters in other countries would only have to comply with one set of rules instead of two.  This would make it easier for them to export and would help their economies.

Aligning EU and US standards and regulations could also provide the basis for high global standards, bringing benefits to consumers and business alike.” (European Commission 2015)

The current engagement with negotiations thus implies a road paved with opportunities and win-win options, yet it seems that many of the claims would require further elaboration.  Furthermore, they do not seem to really hold, when what is actually negotiated is put under scrutiny. In other words, while there may be many lofty aspirations of what is to be achieved, what is negotiated is what counts.

The problem of comparing EU- South Korea FTA with potential benefits from TTIP is of course that it does not compare like with like as trade negotiations with US exceed in breadth what has been agreed with EU-South Korea agreement.  Change is also dependent on situation before and after as well as how particular markets are shaped.  It is also clear that realization of some aspects of what was negotiated with EU- South Korea agreement, for example, in the pharmaceutical annex, will be more problematic in the context of negotiations of TTIP. The likelihood of EU-Korea and the US-Korea agreements to be used as basis for further negotiations has already drawn attention from the European Consumer Organisation (BEUC 2015).

While the rationality of achieving common regulatory practices for the benefits of trade are emphasized, it is not made clear how the scope and requirements for regulation are affected and how a stronger role of multinational industries can affect policy space for health both at European and national and local level role in domestic regulation.  Promises of not lowering current standards are not sufficient, when what matters is how and on what basis new standards can be set and new regulation can take place. Furthermore, through constraining the process of standard-setting and establishing new requirements for regulatory process, the negotiations do have implications for regulatory policy space, even if it would not directly restrict or explicitly deny a possibility for higher level of standards. The purpose and role of regulatory council envisaged as part of negotiations may also have different implications to the Parties. There already exists a relatively strong centrally based presence of regulatory affairs in United States (Office of Information and Regulatory Affairs, OIRA) making this more easily negotiable for USA.  The idea of oversight on regulatory initiative across Atlantic may be appealing to many industries, but may look different from the perspective of Member States.

In many areas industries are no longer local and interests promoted at EU level will be similar to those in USA.  Yet, it is clear that common regulatory process and requirement standards set under influence of multinational actors can be against public interest and the interests of citizens of European Union Member States and citizens of United States, while still making it easier and more beneficial for multinational industries to trade across countries. The win-win for global corporate interests can become a “lose-lose” for public health and public interest.

TTIP and global governance

We do need to question why we should negotiate all public policy and regulatory issues under trade agreements, where agenda is more easily dominated by interests of multinational corporations and coalitions of export industries, when there are other forums for international cooperation. Trade policy should not be the only show in town.

We have United Nations specialized agencies involved with health and food safety. It is perfectly possible to seek closer transatlantic cooperation through other means than trade agreements. If improving regulatory frameworks is the aim of the game, then why are we seeking this through the most difficult route, where corporate interests, in particular, dominate? Another explanation is that what is understood as improvement actually considers improvements for corporate beneficiaries or trade.

This would not need to be the case. Furthermore, the principles and objectives of the Unions’ external action have been defined in TEU (Treaty on European Union) 21 (1) as follows:

  1. The Union’s action on the international scene shall be guided by the principles which have inspired its own creation, development and enlargement, and which it seeks to advance in the wider world: democracy, the rule of law, the universality and indivisibility of human rights and fundamental freedoms, respect for human dignity, the principles of equality and solidarity, and respect for the principles of the United Nations Charter

The Union shall seek to develop relations and build partnerships with third countries, and international, regional or global organisations which share the principles referred to in the first subparagraph. It shall promote multilateral solutions to common problems, in particular in the framework of the United Nations and international law.

These should, in principle, guide also the European Union commercial policy. According to the TFEU (Treaty on the Functioning of the European Union) Article 207 (1) commercial policy is to be “conducted in the context of the principles and objectives of the Union’s external action”. This is partially reflected in Commissioner Malmströms’ speech, where she has emphasised values in foreign policy context of commercial policies (Malmström 2015b):

When partners sign EU trade agreements, they commit to the core standards of the International Labour Organisation– like the right to form unions and strike. They also agree to environmental treaties on issues like transport of hazardous waste and the protection of endangered species.”

…//…

“Furthermore, we also use strategic bilateral trade agreements like the Transatlantic Trade and Investment Partnership as a vehicle to support those EU values that we share with the US – like democracy, open markets, the rule of law, and respect for the individual.”

The challenge is that if TTIP negotiations really represent the democratic values we wish to uphold, it is clear there is a problem in terms of how these democratic values are currently understood, delivered and respected as part of the negotiation process.  United States has not ratified more than two of the eight ILO standards (ILO 2015).  According to ITUC (International Trade Union Confederation) report South Korea is known to have ratified only four of the ILO core labour standards, which do not include right to form Unions and strike (ITUC 2012).  The list of common values promoted by the TTIP seem to lack human rights, equity and solidarity – or perhaps it has been implicitly recognised, that TTIP is not a vehicle to support human rights, equity and solidarity.

If we focus on global governance and the role of European Union, it is possible to argue that current commercial policies are not fully in line with principles and objectives of the European Union external policies. The aim to feed rest of the world standards and regulatory cooperation practices agreed between European Union and United States does not fit well with external policy priorities on multilateral cooperation. It is also unclear how negotiations of TTIP and in particular on investment protection and trade secrets relate to promotion of democracy or consideration of TTIP as a vehicle for promotion of democracy globally.

The relationship between global industries and public policies

The estimates of economic benefits from TTIP have been under scrutiny, but what everybody seems to agree is that key implications from TTIP do not result from lowering tariffs, but from “beyond the border measures” , through changes in future requirements for regulatory measures.  These are much harder to estimate and can also imply unanticipated costs. The question on regulatory action is not just about trade barriers. For example, Joseph Stiglitz has emphasised that (2015):

Rules and regulations determine the kind of economy and society in which people live. They affect relative bargaining power, with important implications for inequality, a growing problem around the world. The question is whether we should allow rich corporations to use provisions hidden in so-called trade agreements to dictate how we will live in the twenty-first century. I hope citizens in the US, Europe, and the Pacific answer with a resounding no.”

What is negotiated in TTIP does relate to health and social policies as what is proposed will have implications to health promotion, protection as well as to financing and organization of health services and social security. While European Union has made promises to exclude publicly funded health services, these remain constrained by overarching commitments to investment protection and potential for overarching obligations for national treatment of investment, regulatory cooperation and in relation to state enterprises and government interventions can. At the core of the concerns is the lack of clear-cut and unequivocal exclusion of health services and social security from the negotiations with potential expansion of more general obligations. (see below)

Regulatory cooperation under TTIP can perhaps be best described as a process seeking to establish procedural framework on how governments can regulate. As these procedures make regulation more burdensome and allow stronger engagement of stakeholders and the other negotiation Party, it is likely to hamper the scope of regulatory measures that governments can take.

Lack of regulation has human and societal costs. What provides benefits for investors and corporations, does not automatically lead to benefits for all, but can imply substantial costs for society at large. The 119 billion € estimated economic benefits of TTIP after ten years on the basis of the Centre for Economic Policy Research (CEPR 2013) assessment are comparable to, although lower than,  estimated annual social costs of alcohol, which have been estimated as 156 billion € (Rehm and Shield 2012). Endocrine disruptive chemicals have been estimated to result in attributable costs of similar annual magnitude to the expected benefits of the TTIP in European Union (Trasande et al. 2015).  The costs of lack of regulation and regulatory action can thus be substantial both in terms of monetary and human costs. The additional requirements and bureaucracy also imply costs for public authorities if they wish to uphold capacity for regulatory action.

While negotiators keep on emphasizing that existing regulatory levels will be upheld, the more cumbersome and more requiring future regulation is made, the harder it will be to enact new regulatory measures.  It is also not clear how TTIP relates to revision of existing regulations and standards. This is particularly important to consider if European Unions’ REFIT (Regulatory Fitness) measures, which will open up and reassess regulatory measures in future as then revision of these new regulations, could be affected by new requirements set as part of TTIP negotiations.

As we are told the importance of growth and the TTIP a crucial means for new growth, it is also necessary to ensure that what is negotiated does not result in “cold growth” accumulating in tax havens with increasing social inequalities, declining public funds, strengthening of the position of multinational industries and corporate monopolies, worsening terms of employment, increasing vulnerability to financial crises, more complex public bureaucratic requirements, and regulatory and public policy impotence.

Enhancing innovation and pharmaceutical policy in the public interest?

A particular case of point needs to be made with respect to pharmaceuticals. It is necessary to ask what public benefits will an even greater influence of global pharmaceutical industry bring to the market approval and reimbursement process of new pharmaceuticals?  It has already been shown that corporate influence can play an influential role in reimbursement decisions in Europe (van Herk et al. 2013).

While the formal focus on pharmaceuticals and TTIP has been on policies with respect to generics and imports from third countries, the real cost pressures for national health systems come from new medicines. High prices of new medicines in both United States and European Union have led to legitimate concerns over the longer term sustainability, affordability and added clinical value of the new medicines, priced at the level that markets can bear.  Yet the TTIP negotiation seem to focus on making it harder for the public administrations to intervene or influence pricing of medicines, while empowering the pharmaceutical industry to maintain and strengthen the current regulatory context and position of major multinational players. Furthermore, from health policy priorities perspective, the more systemic danger of TTIP is that it could hinder necessary change of corporate profiteering and an already failing model for innovation and R&D towards pharmaceutical policy in the public interest.

It is reasonable to assume, that what has been negotiated under Trans-Pacific Partnership (TPP) will emerge to the agenda of the TTIP negotiations. We can thus form some understanding of issues at table from what has been negotiated on the basis of the leaked pharmaceuticals annex of the TPP (TPP 2015). While United States representatives have denied that the transparency annex could be subject to investment protection claims (Weisman 2015), this would be surprising as procedural fairness, which is the aim of the very chapter, provides a feasible route for claims. The relationship between requirements for procedural fairness and what is considered as fair and equitable treatment may also be closer than assumed. Indeed, European Commission explanatory note on investment protection uses these interchangeably:   “Protection against unfair and inequitable treatment – e.g. denying basic procedural fairness “(European Commission 2013, p. 4).

While it may be understandable that producers might seek to ensure the best treatment for their products in other countries, it is not sufficiently recognised that TTIP negotiations can have substantial implications to the ways in which medicines are approved to markets and reimbursed, in particular, within European Union.  Furthermore, while “transparency” seems to be sought in the reimbursement process, there are due concerns over implications of transparency directive to progress in access to data on clinical trials in Europe , which has been criticised by American research-based pharmaceutical industry in their 2014 submission to USTR 301 trade review (PhRMA/USTR 2014). Public health groups and researchers have already drawn concern over definition of trade secrets as part of the transparency directive and links to TTIP negotiations (HAI ym. 2015). Transparency should also not imply a shift towards legitimizing direct-to-consumer advertising in Europe as the TPP transparency chapter seems to seek legitimising more broad-based direct-to-consumer advertising through the internet (TPP 2015).

The danger of the TTIP is that it becomes a protective shield for corporate benefits against duly and timely efforts to change public policies in limiting markets, when commercialization of services becomes too costly, when public interests and opinion do not support profiteering in health services or favour non-profit organizations or public provision (e.g. in publicly funded services), or in the case of pharmaceuticals, using competition to lower prices.  Furthermore, while TTIP is likely to bring growth to the multinational pharmaceutical industry, it is less certain that this will result in taxable income, innovation or cost-effective clinical benefits to patients. On the other hand we can be relatively confident that if exclusivities for pharmaceuticals are expanded or lengthened as result of the negotiations, this is likely to take place at the cost of public purse and those ill, not only within Europe and United States, but as well globally.

We need to be clear that when “high standards” are discussed  this does not only apply to investment and intellectual property rights as it is also important to recognise that trade negotiations can lead to transatlantic sinking of new safety standards, while protecting and tightening those which serve particular interests.  What is good for European Union exporters and industry may not necessarily be safe or great for consumers.

Are health services as “safe” as is claimed ?

TTIP is a negotiated treaty and has its focus on where political priorities are set. It is clear, that while there have been statements on public services (European Commission 2015), this has not so far resulted in explicit exclusions of these services from negotiations.  Legitimate concerns over health, education and social services seem to have become dealt with by separate statements and promises, which are likely to be forgotten, when the final agreement has been signed. We know that it is entirely possible to establish clauses and articles excluding services and sectors or declining to negotiate on investment protection. It is thus a matter of political choice whither we accept health and social security exclusions to remain aspirational and vulnerable to interpretation or explicit “hard” priorities representing European values on what is to be traded and what is not.  It is also likely that other chapters under negotiation, such as government procurement, competition, subsidies or state owned enterprises will have relevance to how publicly financed services can operate and whither these can compete against commercial providers.

There is a danger that trade negotiators may implicitly consider government and public services role as a residual function, where there are no commercial interests. Trade agreements may also impede European problems as internal market rules and regulations may be considered as a starting point for negotiations with third countries.  This applies not only to health services, but as well how services of general economic interest and general interest are understood. The problems emerge if public funding and role for health care provision is pushed to a residual function and required not to affect markets, then excluding publicly funded health services just means excluding services for which there are no commercial interests or which are not tradable.

One concern in relation to the TTIP is the emphasis on general rules and priorities across all sectors. This is reflected in the regulatory chapter on general principles which seeks to build on previous OECD guidance (EU/TTIP 2015).  The shift towards a more general application of rules applies also to TISA (Trade in Services Agreement) negotiations on services on which the TTIP builds, where a push seems again to be from specific commitments to more horizontal obligations (TISA 2015). European Union and Singapore FTA investment chapter expands national treatment obligations for investment to all sectors, including health, social and educational services, with the exception of audiovisual services and procurement for governmental purposes (EU-SSFTA 2014). It may thus be expected that European Commission will seek to expand this horizontal inclusion of national treatment of existing investors in all services also to TTIP. This is not about trade, it is about regulation of national policies.

This has relevance with respect to the role and position of non-profit providers and can affect how services of general interest and general economic interest are treated in service provision as a government may wish to treat these differently from commercially driven multinational corporations, which can provide “like services”. The application of restrictions to performance requirements could limit means to ensure continuity of care, equity in access to services or to ensure efficient use of resources within the health system.

Health services or national exclusions on health services from trade agreements are not necessarily as “safe” as we have been told, if exclusions only apply to ability to restrict new establishments, while governance of national policies and investment has slipped further under trade agreements.

The paradox of evidence in the context of TTIP negotiations

The paradox of the TTIP negotiations is that an international legal framework limiting public policy options and policy space for health is negotiated with very limited evidence on broader societal benefits, while this very framework will not only require increasing and more narrowly defined evidence for future regulatory measures to take place, but can also make it more difficult to gain evidence for public policies and regulation for health.

It is clear that costs from TTIP have not been addressed fully in terms of investment protection, lack of regulatory action, regulatory burden for governments or increased costs for new medicines and technologies. Even broader financial sustainability issues may be at stake in the context of financial services chapter, including social security systems or vulnerability to new financial crises. The legal language introduces new terminology and obligations, which may not be fully understood in terms of implications as this type of requirements may not have been dealt with as part of health policy-making and governance.  While consultations have provided managed information and sharing of European Union stances to the wider public and academic research, which is an improvement, the consolidated negotiation texts are still available only to chosen few.

The focus on transparency may seem a move to the right direction, but measures promoted under transparency seem to go only to one direction. There is a danger of creating a transparency ratchet, where all that is on public sector remains open and accessible to early scrutiny by corporations, while at the same time access to information for regulatory purposes from the corporate sector becomes safeguarded by stronger protection of trade secrets.

A major challenge with respect to “evidence” relates to precautionary principle. It is also clear that impact assessments have shifted to serve more commercial needs with proposals of regulatory and trade impact assessments (EU/TTIP 2015). A reaffirmed commitment to OECD good regulatory practices is to be made as part of the agreement (OECD 2012), which raises also questions of purpose and role of the regulatory cooperation focus. If OECD already provides soft guidance on regulatory cooperation, the TTIP can’t be about “soft” guidance, but seems to be much more about locking in a framework for regulatory cooperation and enforcement through TTIP.  Furthermore, if the agreement is a “living agreement”, the initial negotiation round will need to be only a placement for further negotiations.

If TTIP is the answer, then what is the problem?

It is possible to argue that trade should preferably be negotiated under multilateral governance with a broad participation and actual transparency, rather than making a bilateral deals and then imposing them to all others, which does not sound as great foreign policy or respect for democratic accountability.

Governments can deregulate without a broader international framework and if TTIP partnership is only about “encouraging” regulatory cooperation, then perhaps this encouraging could be done in a less legally binding form under OECD. Most of health promotion legislation has not taken place as result of international agreements, but as result of governments following wise regulatory measures of other governments.  As world has not ended in spite of corporate predictions, other governments have dared to follow the lead. However, the TTIP fits perhaps too well with an aim to ensure that there is less scope for innovative regulatory measures for the benefit of public health policies through the imposition of a more restrictive overarching regulatory framework, enhancing investor and intellectual property rights protection, and enabling early corporate presence as part of the regulatory process.

Do trade policies then really suffer from lack of empowerment of multinational industries and insufficient consideration of corporate and transnational investor interests as part of public policy-making and regulatory decisions in European Union and United States?  Do we really need to have consultations across Atlantic or a regulatory council on potential regulatory interests in case these might affect trade interests? Why should framework for health-related standard-setting and regulation be decided under closed trade negotiations between United States and European Union?

The pass of the fast track vote in USA implies that more scrutiny and oversight is now required from the European Union side and, in particular, from the European Parliament. The process of the European Parliament vote was not promising. If a closer partnership is to be desired, then any advancement of regulatory cooperation with respect to pharmaceuticals, health promotion, health, environmental protection and safety should best take place elsewhere, than under trade or corporate friendly regulatory councils governed under trade and economic policy priorities. Innovative solutions could be sought on the basis of public health and health policy priorities and has been done. The point is not about international cooperation, it is about where, on what basis and for what purpose this cooperation takes place.

 

References

CETA (2014) Comprehensive Trade and Economic Agreement.  Avaible from: http://ec.europa.eu/trade/policy/in-focus/ceta/

European Commission (2015) Questions and answers.  Available from: http://ec.europa.eu/trade/policy/in-focus/ttip/about-ttip/questions-and-answers/index_en.htm

European Commission (2015) Joint Statement 20 March 2015.  Available from: http://europa.eu/rapid/press-release_STATEMENT-15-4646_en.htm

European Commission (2013) Fact Sheet. Investment Protection and Investor-to-State Dispute Settlement in EU agreements. November 2013. Available from: http://trade.ec.europa.eu/doclib/docs/2013/november/tradoc_151916.pdf

EU/TTIP (2015) Regulatory chapter proposal 4th of May 2015. Available: http://trade.ec.europa.eu/doclib/html/153403.htm

EU-SSFTA (2015) Draft EU-Singapore FTA. October 2014. Chapter 9. Investment. Available from: http://trade.ec.europa.eu/doclib/press/index.cfm?id=961

HAI et al. (2015) EU trade secrets directive threat to free speech, health, environment and worker mobility. 23 March 2015. Statement.  Available from:  http://haieurope.org/wp-content/uploads/2015/03/Statement-updated-on-trade-secrets-directive.pdf

ILO (2015) Ratifications for United States. Available from: http://www.ilo.org/dyn/normlex/en/f?p=1000:12001:0::NO:::

ITUC (2012) Internationally recognised core labour standards in Republic of Korea. Report for the WTO General Council review of the trade politics of Republic of Korea. Geneva, 19 and 21 September, 2012. Available from: www.ituc-csi.org/IMG/pdf/korea_tpr_final.pdf

Krugman P (2015) This is not a trade agreement. April 26, New York Times.  Available from: http://krugman.blogs.nytimes.com/2015/04/26/this-is-not-a-trade-agreement/?_r=0

Malmström C (2015a) Bringing EU trade policy up to date. 23 June. Speech. European Trade Policy Day. Keynote (website).Available from: http://trade.ec.europa.eu/doclib/press/index.cfm?id=1334

Malmström C (2015b) Integrated trade and  foreign policy. 11 of June. Speech Annual on European Council of Foreign Relations. Available from: http://trade.ec.europa.eu/doclib/press/index.cfm?id=1328

OECD (2012) Recommendation of the regulatory council on regulatory policy and governance. Available from: www.oecd.org/governance/regulatory-policy/49990817.pdf

PhRMA/USTR (2014) Pharmaceutical Research and Manufacturers of America (PhRMA)special 301 submission 2014. Available from: www.phrma.org/sites/default/files/pdf/2014-special-301-submission.pdf

Rehm and Shield (2012) Alcohol consumption, alcohol dependence and attributable burden of disease in Europe. Amphora project. Centre for Addition and Mental Health, 2012. Available from: http://amphoraproject.net/w2box/data/AMPHORA%20Reports/CAMH_Alcohol_Report_Europe_2012.pdf

TISA (2015) Domestic regulation. Available from: https://wikileaks.org/tisa/domestic/

TPP (2015) Transparency chapter. Available from: https://wikileaks.org/tpp/healthcare/

Trasande L, Zoeller RT, Hass U, Kortenkamp A, Grandjean P, Peterson  Myers J, DiGangi J, Bellanger M, Hauser R, Legler J, Skakkebaek NE, and Heindel JJ (2015) Estimating Burden and Disease Costs of Exposure to Endocrine-Disrupting Chemicals in the European Union. The Journal of Clinical Endocrinology & Metabolism 2015 100:4, 1245-1255. Available from: http://press.endocrine.org/doi/ref/10.1210/jc.2014-4324

Stiglitz J (2015) The secret corporate takeover. May 13 2015. Available from: http://www.project-syndicate.org/commentary/us-secret-corporate-takeover-by-joseph-e–stiglitz-2015-05

Summers L (2015) Rescuing free trade agreements. June 14, 2015. The Washington Post. Available from: http://www.washingtonpost.com/opinions/rescuing-the-free-trade-deals/2015/06/14/f10d82c2-1119-11e5-9726-49d6fa26a8c6_story.html

Van Herck P, Annemans L, Sermeus W, Ramaekers D (2013) Evidence-Based Health Care Policy in Reimbursement Decisions: Lessons from a Series of Six Equivocal Case-Studies. PLoS ONE 8(10): e78662. doi:10.1371/journal.pone.0078662

Weisman J(2015) U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals. New York Times June 10, 2015. Available from: http://www.nytimes.com/2015/06/11/business/international/us-shifts-stance-on-drug-pricing-in-pacific-trade-pact-talks-document-reveals.html?_r=2

 

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*Meri Koivusalo is a senior researcher in National Institute for Health and Welfare in Finland. She is a medical doctor with a PhD in public health and MSc in environmental health policy. She has written and published on international and European health policies, including on trade and health. She has followed trade policy developments for more than 15 years. She has served as an advisor for Finnish Ministry of Social Affairs and Health as well as for European Commission DGV, DG VIII and WHO. She was a member of the WHO Consultative expert group on research and development: financing and coordination (CEWG). 

We Have a Dream: Universal Early Access to Innovative, Life-Saving Medicines

In April 2015, The WHO Expert Committee, tasked with the review and update of the WHO Lists of Essential Medicines for adults (EML) and children (EMLc), recommended the addition of 36 new medicines to the EML, and of 16 to the EMLc. It is hoped that the indications of the WHO Expert Committee will be considered and followed by all the concerned stakeholders, including pharmaceutical companies and policy makers

raffaella ravinetto

by Raffaella Ravinetto*

Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine

WE HAVE A DREAM: UNIVERSAL EARLY ACCESS TO INNOVATIVE, LIFE-SAVING MEDICINES

 

The inclusion of antiretroviral medicines in the WHO Model List of Essential Medicines (EML) represented in 2002 an important step in the path toward getting universal access to medicines for HIV/AIDS. Even if the overarching goal is not reached yet, the inclusion of ARVs in the WHO EML gave a strong message that these medicines must be available to all those in needs, because of their safety and efficacy for treating an otherwise deadly disease, and irrespectively of their price. The inclusion of antiretrovirals in the WHO EML  slightly preceded the launch of other key-initiatives, such as  the WHO Pre-qualification project (1) and the Global Fund, aimed respectively at giving guidance on the choice of quality-assured generics, and at facilitating the universal access to life-saving medicines for HIV/AIDS, malaria and tuberculosis.

More than a decade after this milestone event, the 20th meeting of the WHO Expert Committee on the Selection and Use of Essential Medicines made in April 2015 other “essential” choices. The Expert Committee, tasked with the review and update of the WHO EML for adults and of the Model List of Essential Medicines for children (EMLc), recommended the addition of 36 new medicines to the EML (15 to the core list and 21 to the complementary list), and of 16 to the EMLc (five to the core list and 11 to the complementary list)[1]. The new essential medicines cover a wide range of conditions, including multi-drug resistant tuberculosis, extensively drug resistant tuberculosis (XDR) and pre-XDR, HIV/AIDS, viral hepatitis, cancer, cardiovascular diseases,  and contraceptive products (2, 3). Some of the choices made by the Expert Committee, are in line with the principle that early access to innovative, life-saving medicines should be universal.

The case of viral hepatitis The new EML sub-section for hepatitis C includes six oral direct-acting antiviral (DAAs) medicines: daclatasvir, ledipasvir + sofosbuvir, ombitasvir + paritaprevir + ritonavir with or without dasabuvir, simeprevir, and sofosbuvir, chosen on the basis of “comparative efficacy, increased tolerability and the potential public health impact”.

The high prices of these medicines are making their access extremely challenging not only in middle- and low-income countries (LMICs) (4), but also in some high-income countries (5), and could have discouraged their inclusion in the EML. Conversely, according to the WHO, “the very high cost of hepatitis C medicines was considered and the Committee recommended that WHO take actions at global level to make these medicines more accessible and affordable”.  This decision strongly underlines the need to ensure access to DAAs for all those in need. It is now hoped that it may trigger other international initiatives to upscale the access to DAAs, just as it happened 13 years ago with antiretrovirals. Noteworthy, a few months before the new EML was issued, the WHO Pre-qualification had already expanded its scope to hepatitis C (6), as a first step to provide reliable guidance on quality-assured generic versions of these medicines.

The case of cancer medicines Hepatitis C is, like HIV/AIDS, malaria and tuberculosis, an infectious disease, and so far the focus of most “access” initiatives has been on transmissible diseases, whether present worldwide or mainly/ exclusively prevalent in LMICs. But LMICs are not exclusively of mainly hit by infectious diseases, and the morbidity and mortality of non-transmissible diseases such as cancer, cardiovascular diseases and diabetes, are steadily increasing. For instance, according to the WHO, more than 60% of world’s total new annual cases of cancer occur in Africa, Asia and Central and South America, and these regions account for 70% of the world’s cancer deaths. Ensuring universal access to anti-cancer medicines  thus represents a major ethical challenge for the international community (7).

The EML Committee has recommended the addition to the EML of 16 medicines for cancer, and it has endorsed the use of 30 medicines for the treatment of specific cancers. Among the recommended medicines there are some high-cost medicines (including imatinib, trastuzumab and rituximab), for which the possibility of universal access may also be put at stake by intellectual property issues and high prices. Their inclusion in the EML underlines that early access to innovative essential medicines should be seen as a human right irrespectively of whether they are costly or not, and irrespectively of whether the concerned diseases have or have not a potential for epidemics.

It is hoped that the indications of the WHO Expert Committee will be considered and followed by all the concerned stakeholders, including pharmaceutical companies and policy makers.

 

References

1) ‘t Hoen EFM, Hogerzeil HV, Quick JD, Sillo H. A quiet revolution in global public health: the World Health Organization’s Prequalification of Medicines Programme. Journal of Public Health Policy 2014; doi:10.1057/jphp.2013.53

2) 19th WHO Model List of Essential Medicines (April 2015) . Last accessed on 5th July 2015 at http://www.who.int/medicines/publications/essentialmedicines/EML2015_8-May-15.pdf

3) WHO Model List of Essential Medicines for Children (April 2015). Last accessed on 5th July 2015 at http://www.who.int/medicines/publications/essentialmedicines/EMLc2015_8-May-15.pdf

4) Kamal-Yanni M. Hepatitis C drug affordability. Lancet Global Health 2015; 3: e73-e74

5) Brunetto MR et al. Reducing the price of new hepatitis C drugs in the Tuscany region of Italy. BMJ. 2015 Jun 24;350:h3363

6) 12th Invitation to manufacturers and suppliers of medicinal products for HIV infection and related diseases, including treatment for hepatitis B and C, to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Team – Medicines Last accessed on 5th July 2015 at http://apps.who.int/prequal/info_applicants/eoi/EOI-HIV-v12.pdf

7)  ‘t Hoen E. Access to Cancer Treatment: A study of medicine pricing issues with recommendations for improving access to cancer medication. A report prepared for Oxfam, 2014.

[1] The core lists present a list of “minimum medicine needs for a basic health‐care system, listing the most efficacious, safe and cost‐effective medicines for priority conditions”, while the complementary lists present essential medicines “for priority diseases, for which specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist training are needed”.

 

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*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.   

After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).   

Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health. 

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The Reasons Behind the Flop of Alma-Ata Principles

The Alma-Ata Declaration was endorsed by the 32nd World Health Assembly held in Geneva in 1979, which approved a resolution acknowledging the key role of primary health care (PHC) for the attainment of  acceptable health levels for all. However, despite the initial enthusiasm, it was difficult to implement healthcare in accordance with Alma-Ata principles.This article turns the spotlight on the relevant reasons

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by Pietro Dionisio

Degree in Political Science, International Relations

Cesare Alfieri School, University of Florence, Italy

The Reasons Behind the Flop of Alma-Ata Principles

 Universal Health Coverage: Really a Long Way Off

 

“The main goal of universal health coverage is to ensure that all people obtain the health services they need without suffering financial hardship when paying for them in order to avoid any poverty trap” [1].

For a country to achieve universal health coverage (UHC), several factors must be in place, including:

1) A strongly efficient, well-run system meeting health priority needs through a people-centred, integrated approach based on:

-proper information and tutorial strategies for health keeping and disease prevention;

-early detection of conditions negatively affecting health;

-appropriate disease treating capacity; and

-adequate care and rehabilitation frameworks.

2) Affordability, by effective public health financing services that give up out-of-pocket expenses by the users.

3) Equity, including by securing non-discriminatory access to essential medicines, care  and technologies for health and to services for communicable/non-communicable diseases and maternal/child health.

4) Well-trained, motivated and skilled health workers to meet the needs of patients through high quality, best available evidence services.

The points above are without prejudice to the critical role in assuring human health played by sectors including transport, urban planning and overall education services.

UHC has a direct impact on people’s health. Universal access to health services enables people to become more productive and active contributors to their families and communities. It also ensures that children can go to school and learn. At the same time, financial risk protection prevents people from being pushed into poverty when they have to pay for health services out of their own pockets. UHC is thus a critical component of sustainable development and poverty reduction, and a key element of any effort to reduce social inequities and inequalities. In essence, UHC is the hallmark of a government’s commitment to improve the well-being of all its citizens.

UHC is firmly based on the WHO constitution of 1948, declaring health a fundamental human right, and on the Health for All agenda set up by the Alma-Ata Declaration in 1978. In such a context, equity is a paramount, meaning that countries need to track progress not just across a vague “national population” term but within different groups including by income level, sex, age, place of residence, civil engagement, social attitudes and behaviors, migrant status and ethnic origin.

The Origins of Primary Health Care

The concept of primary health care (PHC), in the last decades, has had a noteworthy influence upon health workers, especially in less-developed countries.

Since the late 1960s and early 1970s, the US was involved in a crisis of its world hegemony. It was in this political context that the concept of PHC emerged. Since this moment, the vertical health approach[2] used in the fight against malaria by US agencies and WHO was being criticized. New proposals for health and development appeared. For instance, Kenneth W. Newell, a WHO staff member since 1967, who collected and studied the experiences of medical auxiliaries in developing countries, argued that “ a strict health sectoral approach is ineffective”[3]. In addition, the 1974 Canadian Lalonde Report[4] deemphasized the importance attributed to the quantity of medical institutions and proposed four determinants for health: biology, health services, environment and lifestyles[5].

An important role for the PHC concept formation was played by the Christian Medical Commission. As a specialized branch of the World Council of Churches and the Lutheran World Federation, this organization was created in the late 1960s with the mission to emphasize the training of grassroots village workers equipped with very essential drugs and simple methods. In 1970, it created the successful journal “Contact”, which adopted the expression “primary health care” (one of the first times this term was used). Noticeably, from 1974 a collaboration between the Commission and WHO was formalized.

A further element to be taken into account to understand the inspiration for PHC, was the widespread attention worldwide to the massive expansion of rural medical services experienced in communist China. In this process a notable role was played by the so called “ barefoot doctors” whose number increased between early 1960s and the cultural revolution. They were a different group of village health workers who lived in the community they served by actively stressing rural rather than urban healthcare, preventive rather than curative services and combining Western and traditional medicines[6].

The emergence of PHC was also backed by the new international context characterized by the presence of decolonized African nations and the propagation of national, anti-imperialist and leftist movements in many less-developed countries. These changes led to new proposals by some industrialized countries.

The main event towards the achievement of PHC model was the  international conference taking place at Alma-Ata (Soviet Union) on 6-12 September 1978.

The idea of an international conference on PHC emerged from the Chinese delegation to the WHO. At the beginning, the Soviet Union opposed the proposal by upholding a more medically oriented approach for less-developed countries. Subsequently, based on awareness that PHC  movement was growing, they started supporting the meeting  and offered a location too[7].

Nearly 3000 delegates from 134 countries and 67 international organizations took part in the conference which was also attended by UN and international agencies like the International Labor Organization, the Food and Agriculture Organization and the Agency for International Development. NGOs, religious movements (including the Christian Medical Commission), the Red Cross, Medicus Mundi and political movements including the Palestine Liberation Organization and the South West Africa People’s Organization, were also present, whereas, for political reasons, the Chinese Government was absent[8].

The fact that this conference represented a cornerstone event in the history of international healthcare, is demonstrated by the Declaration it released as an universal and bold statement  mainly focusing on three points:

  • appropriate technology;
  • opposition to medical elitism;
  • health as a means to achieve social-economic development.

Regarding the first point, the used expression “disease oriented technology” incurred the criticism of envisaging too much sophisticated, expensive or irrelevant technologies to the common needs of the poor. Critics also stressed that the creation of urban hospitals in less-developed countries would forge a culture running contrary to the independency of consumers, while only benefiting a minority through a poor share of available funds and human capital. In order to solve these issues, it was emphasized the need of using equipped medical technology to link in with people needs, while being scientifically sound and financially feasible. Relevantly, a decentralized approach based on setting up health units in rural areas, in lieu of city hospitals, was seen as a more cost-effective policy.

The second point emphasized the opposition against medical elitism including health personnel overspecialization and top-down health policies in developing countries. In this connection, the Declaration focused on the need to appropriately train health staffs and increase the participation of communities in sanitary matters. The need for working together with traditional healers, such as shamans and midwives, was also emphasized.

The third point of Declaration linked health to development. Health was seen not as an isolated element but as an intrinsic tool to achieve improvements of life conditions by an inter-sector approach whereby public and private institutions should work together on health education, adequate housing, safe water and basic sanitation, among other things. This vision echoed in the words of WHO Director H.T. Mahler supporting the idea that health, far from being a mere byproduct of economic progress should be a key engine for development “we could. . . become the avant-garde of an international conscience for social development”[9].

The Alma-Ata Declaration was endorsed by the 32nd World Health Assembly held in Geneva in 1979, which approved a resolution acknowledging the key role of  PHC for the attainment of  acceptable health levels for all.

However, despite the initial enthusiasm, it was difficult to implement healthcare in accordance with the Alma-Ata principles.

Criticism to Alma-Ata and New Proposals for PHC

The Alma-Ata Declaration was criticized for being too wide and for having an unrealistic timetable (the slogan “health for all by the years 2000” was considered not feasible by a great portion of scholars).

In this regard, the Rockfeller Foundation in 1979 held a conference in order to identify the most cost-effective strategies and examine the status of interrelation between health and population programs. The meeting was inspired and based on a paper by Julia Walsh and Kenneth S. Warren entitled: “Selective primary healthcare, an interim strategy for disease control in developing countries”[10]. The paper, which did not represent criticism against the Alma-Ata Declaration, focused on specific causes of death, largely on the most common children’s threats in developing countries, including diarrhea and diseases following the lack of vaccination programs. The authors highlighted an entry point strategy through which basic health services targeted to achievable objectives could feasibly be developed both in financial and temporal terms. This new perspective was named “selective primary healthcare”, meaning  a set of low-cost technical interventions to address some crucial health problems in less-developed countries.

In essence, the selective primary healthcare (SPHC)  mainly focused on four interventions:

  • growth monitoring;
  • oral rehydration techniques;
  • breast-feeding;
  • immunization

Growth monitoring was considered an important instrument to identify, at an early stage, children who were not growing as they should.

Oral rehydration aimed at controlling diarrheal disease outbreaks by electrolyte water solution packets.

Breast-feeding emphasized the protective and nutritional value of giving breast milk alone to children for the first six months of their life.

The last intervention, immunization, underpinned vaccination campaigns against communicable diseases, especially in the early childhood.

These four interventions have indeed several positive effects: they are easy to control and evaluate, are measurable, have clear targets and, due to the fact that indicators of success and reporting can rapidly be produced,  earmarked funding appears quite easy to obtain.

Relevantly, a debate came out soon between PHC and SPHC approach backers.

The backers of comprehensive PHC accused SPHC of being an approach diverting attention away from basic health and social development while not taking into proper consideration, and so not addressing, the social causes of diseases. Another point  under the fire of criticism  was the fact that monitoring was difficult to undertake since it required the use of charts by illiterate mothers.

And Newell, one of the architects of PHC idea, stated that “[SPHC] is a threat and can be thought of as a counter-revolution. Rather than an alternative, it . . .can be destructive . . . Its attractions to the professionals and to funding agencies and governments looking for short-term goals are very apparent. It has to be rejected”[11].

In the face of this, US agencies, the World Bank, and UNICEF started to focus on some aspects of SPHC. As a result, there was mounting friction between the WHO and UNICEF during the early 1980s, with debate centred around three main questions:

-What is the meaning of PHC?

-How is PHC to be financed?

-How is it to be implemented?

PHC has several meanings, so it was not easy to define. In its more radical version, it was seen as an adjunct of social revolution. This perspective was considered as something undesirable and drew a lot of criticism against Mahler and WHO that began to be seen as a politicized organization. Others considered this point of view simply unrealistic and thought it was impossible to expect those changes from the conservative governments of developing countries. Firstly, they stated that the political power of rural people was overestimated and that, consequently, the thrust of some health experts was misplaced. Another bone of contention was the vision of communities in the developing countries as a pyramid willing to participate in health programs should its leaders be given the necessary information. This vision was judged quite idealistic on the grounds that those communities and their learning processes were often diverse and complex.

Critics also considered the PHC target of extending health services to rural areas as an addition to preexisting medical services. As such, they saw PHC as a second quality care,  something like “primitive” and a means to keep poor people under social control.

The second point of debate referred to the financing procedure in order to make the Alma-Ata Declaration a sustainable one. Admittedly, when compared with other international campaigns (such as the global malaria eradication program of the 1950s, where bilateral funding assistance was provided by UNICEF and the US), no clear funding resources were quoted in the Declaration as regards health workers training, nutrition and safe water programs or new hospitals building. As a result, it comes as no surprise that many international agencies did prefer to engage in short-term, clear budget initiatives rather than in too broad programs [12].

This links in with the fact that, during the 1980s, several less-developed countries faced an economic slump and burdensome foreign debt that negatively impacted on the availability of public resources for  health. Moreover, a drastic restriction in the available funding for healthcare in developing countries arose from the emergence of neo-liberal policies by governments in the most affluent countries.

This changing political context fostered deeply rooted conservative attitudes among health professionals. For instance, several high-income physicians, based in city hospitals and trained in prestigious medical schools (like US universities), used to consider PHC as a professional step-down in monetary and social prestige terms. The resistance of medical doctors worsened at the time when, coupling with awareness of the lack of any effort to reorganize medical education around PHC and enhance the prestige of personnel, they feared they were going to lose their privileges and power.

An additional problem, as mentioned above, referred to  the implementation of the Declaration. In the post Alma-Ata period, different strategies were adopted by the signatory countries:

  1. Negation: no concrete steps were undertaken to put the Declaration into practice.
  2. Legislation: the Alma-Ata Declaration was copied into a lot of National Legislations. Sometimes this was a starting point for action, other times it was the start of a continuous process of “lip-service” to PHC ideas, without concrete political commitment.

When action was undertaken, four strategies emerged:

  • Implementation: for some countries (Cuba and the rural areas of China) the implementation of the Declaration was in continuity with already existing developments.
  • Adaptation of existing health systems: many countries opted for healthcare reforms, trying to implement the Alma-Ata Declaration by a process of change of the existing healthcare structures.
  • Innovation: countries opting for starting a primary healthcare structure, apart from the existing system.
  • Importation: the primary healthcare system was “imported” into the framework of bilateral cooperation, multilateral agencies or non- governmental organizations.

Due to the fact that a great majority of international agencies favored SPHC, many less- developed country governments decided to create underfunded PHC programs by concentrating efforts mainly on one or two selective interventions. As a result, the friction between those who advocated vertical, disease oriented programs and those who advocated community oriented programs was accepted as a natural state of affairs, irrespective of  the situation of confusion and inefficiencies bound up with this context.

During the 1980s, Mahler continued his fight for a comprehensive PHC, but he was quite often alone because of the inadequate support by WHO’s bureaucracy and his allies outside WHO. When, in 1988, Mahler ended his third mandate as WHO Director General, none of the candidates to succeed him seemed to have the right energy to bring off the battle for comprehensive PHC.

The Japanese Hiroshi Nakajima was elected as the new WHO Director General, and it was immediately evident that the communicativeness and the charismatic personality of his predecessor were lacking.

In the last decade of the 20th century, it became clear that the goal of  “health for all by the years 2000” would not be reached. Part of the reasons can be summed up as follows:

– The focus on SPHC and on “vertical programs” was disruptive for the development of an horizontal PHC approach taking care of individuals, their families and communities. Relevantly, the HIV/AIDS pandemic played a key role by shifting budgets towards “vertical programs”, instead of PHC investment programs.

– Moreover, the PHC strategy underestimated the power of pharma industry and hospitals in the healthcare system, and failed to take doctors into proper consideration. This coupled with the lack of a clear strategy to adequately train doctors and health worker staffs, even if the idea of multidisciplinary PHC teams was present in all documents. Taken together, these circumstances brought about a slowdown in the development of PHC project[13].

– Additionally, a point of weakness referred to donor agencies’ requirements of results to be achieved by the funding cycle period or the agency’s mandate. While encouraging short-term planning and readily measured program objectives, these requirements ruled out the engagement in PHC[14] and civil society involving projects looking at bottom-up approaches and participatory frameworks including relevant to health infrastructures building.

– Another bar to the achievement of  UHC was the feeling that the PHC idea strictly linked  in with the concept of solidarity. This value came under pressure in the 1980s and the 1990s. The disappearance of the “Iron Curtain”, the “war on terror”, the growing individualization and globalization, with increasing flows of migrants, all eroded the idea of solidarity as the basic engine for comprehensive PHC regimens.

– Many problems also arose from the fact that the Declaration was filled with ideology. It clearly stated, indeed, what to do but not how to reach the goals laid down in its statements. As such, many professionals and decision makers regarded its principles only as  program indicators to directly translate into operational resolutions and policy directions of each country. Relevantly, even WHO stated that: “in their post Alma-Ata enthusiasm many decision makers assume that, since primary healthcare is supposed to use simple methods, it would be simple to implement”[15].

– What’s more, obstacles even arose from the fact that the need for contextual adaptation of the Alma-Ata principles was underestimated. The PHC approach was expected to act as a flexible model prone, at least in principle, to readapt to local needs and situations. In reality, because of its conceptual appeal, because of its heavy international promotion by WHO and other international bodies and because of deep gaps in many countries needing immediate action, it was often adopted without first exploring and defining the socio-cultural environment on to which it had to be implanted. Health planners from WHO and national governments failed to grasp the complexity of social organization within rural settings, and even failed “to construct resource foundation adequate for describing health and illness as processes constituted as much by forces of languages, socio-cultural structure, political and economic organization as biological and psycho-physical events”[16].  This lack of contextual organization brought about problems to international agencies, national governments, ministries of health, local authorities who were defining their central objectives by the theoretical framework of PHC. As an example, while rural inhabitants generally wanted the attainment of as much care and treatments as their urban counterparts,  PHC advocates often ignored this reality, labelling instead the villagers for not quickly perceiving the true advantages of preventive healthcare, something that took international healthcare professionals decades to grasp. As such, there was a perpetration of illusion that PHC could deliver new, valuable messages into a social vacuum[17].

– The circumstances highlighted above linked in with evidence that the problems faced by the PHC proponents were really huge. As such, grounding on awareness that no miracle solution would be able to quickly transform global social and economic inequalities into something better, the PHC proponents understood that the completion of PHC project would take a very long time while hinging on the policy directions by governments and their impact on health, society, equity, politics and world order outcomes.

Overall, as a result of the facts stressed so far, the PHC  model was introduced at very variable levels in the countries worldwide.  Irrespective of the lot of gaps and inefficiencies bound up with these circumstances, especially in Africa and less-developed countries, some results from PHC implementation even in those countries with incredible social and economic problems are being documented. As in the case of Kenya where the political will of  government and international aid resources have been producing significant improvements in the UHC issue.

Unfortunately, despite isolated examples, there is still  hard work to do now that the impact of governments’ policies on public health and access to care and appropriate, affordable, high-quality treatments is an issue of global concern in the international agenda.

And this occurs at a time when free trade agreements and choices by the administrations in wealthy countries are turning policies into decisions which protect monopolistic interests at the expense of non-discriminatory, equitable access to health.

Admittedly, the struggle against economic and governmental interests is long and hard. But this is another story.

 

REFERENCES

[1]WHO, “What is Universal Coverage?”, World Health Organization. Web source: http://www.who.int/health_financing/universal_coverage_definition/en/

[2]The vertical approach focuses on fighting one disease at time. The horizzontal one, as defined by WHO, focuses on “ all the activities whose primary porpuse is to promote, restore or maintain health”.

[3]K.W. Newell. “Health by the people”, Geneva, Worl Health Organization, 1975,xi.

[4]The Lalonde Report is a 1974 report produced in Canada. It proposed the concept of “health field”, identifying two main health-related objectives: the healthcare system; and prevention of health problems and promotion of good health. The report is considered the first modern government document in the Western world to acknowledge that our emphasis upon a biomedical health care system is wrong, and that we need to look beyond the traditional health care (sick care) system if we wish to improve the health of the public.

[5]Canadian Department of National Health and Welfare, A New Perspective on the Health of Canadians. ( Ottawa, 1974)

[6]V. W. Sidel, “The Barefoot Doctors of the People’s Republic of China”, New England Journal of Medicine 286 (1972): 1292-1300.

[7]The offer, also, resulted from a growing competition between the traditional communist parties and the new pro-chinese organizations that emerged in several developing countries.

[8]The Sino-Soviet conflict had been worsening since the 1960s.

[9]H. T. Mahler, “WHO’s mission revisited: Address in presenting his report for 1974 to the 28th World Health Assembly, 15 May 1975”, 10, Mahler Speeches/Lectures, box 1, WHO Library, Geneva.

[10]Walsh J. A., Warren K. S., “Selective primary healthcare, an interim strategy for disease control in developing countries”, N. Engl. J. Med., 301, 967-974, 1979.

[11]K. W. Newell, “Selective Primary Healthcare: the Counter-Revolution”, Social Science and Medicine 26 (1988): quote from p. 906.

[12]S. B. Rifkin, F. Muller and V. Bich-mann, “Primary Healthcare: On Measuring Partecipation”, Social Science and Medicine 26 (1988), 931-940.

[13] The openness of the public towards interventions from public health (campaigns for prevention, health promotion) is influenced positively by the presence of efficient clinical curative services because they contribute to the creation of “trust” towards the health system. The primary health care-services were relying to a large extent on nurses for the clinical work, but very often they were faced with diagnostic responsibilities that they were not prepared for.

[14]PHC: Primary Healt Care.

[15]WHO: National Health Development Networks in Support of Primary Healthcare. Geneva, World Health Organization, 1986.

[16]LH. Connor, N. Higgenbothon: A sociocultural perspective on rural health development: a proposal for educating health professionals in Asia and the Pacific. Honolulu, East-West Center, 1983.

[17]L. Stone: Primary healthcare for whom? Village perspectives from Nepal, Social Science and Medicine 1986; 22 (3), pp. 293-302.

Why ’Big Pharma’ Alone Cannot End the AIDS Pandemic

The major focus in both national and international responses to HIV  pandemic is now on ensuring that as many positive people as possible have sustainable access to the specific drugs. But, whatever their medical efficacy they can only ever provide a partial solution to what has become a ‘post modern plague’ in so many of the poorest parts of the world. The coming decades are likely to be ones of increasing need and declining resources. Hence optimistic suggestions that drugs alone will soon bring an end to the pandemic will need to be treated with the greatest caution

lesleydoyal

by Lesley Doyal*

Emeritus Professor, School for Policy Studies

University of Bristol, UK

Why ’Big Pharma’ Alone Cannot End the AIDS Pandemic

 

Debates about the pharmaceutical industry have received new impetus over the past decade with the introduction of antiretroviral therapy (ART) for many of the millions diagnosed as HIV positive. Though these drugs do not offer a cure they do hold out the possibility of major improvements in wellbeing and life expectancy for those who are able to access them.

The major focus in both national and international responses to the pandemic is now on ensuring that as many positive people as possible have sustainable access to these drugs. But as we shall see, whatever their medical efficacy they can only ever provide a partial solution to what has become a ‘post modern plague’ in so many of the poorest parts of the world.

When ART first became available in the mid 1990’s, it was confined to high income countries with sophisticated health care systems. Some commentators argued against attempts to extend access to the poorer parts of the world on the grounds that lack of adherence would cause what they called ‘antiretroviral anarchy’. However many others campaigned against such a ‘double standard’, demanding a more equitable distribution of drugs (Chan 2015 ch3).

Early attempts to achieve more widespread dissemination were, of course, limited by the high cost of the drugs themselves. This led inevitably to lengthy battles with pharmaceutical firms over pricing as well as issues of intellectual property (Chan 2015). But aided by the production of substantial quantities of generic drugs in countries such as India and Brazil the wholesale price of first line drugs fell markedly after 2001. This made possible a dramatic increase in the number of people receiving treatment. By 2011 this figure had risen to a record 9.7 million compared to just over 8.1 million in 2011 – an increase of 1.6 million in one year alone (WHO,UNICEF& UNAIDS 2011). But many problems still remain.

First, there are still marked inequalities in access to ART. The most obvious of these are differences between rich and poor countries. Currently treatment in the US and Western Europe is accessed by more than 50% of all those known to be in clinical need. In Eastern Europe however the figure is only 21% and in the Middle East and North Africa it falls to only 11% (UNAIDS Fact Sheet 2014).

These inequalities partly reflect the wealth or poverty of individual countries and the strength or weakness of their national care systems. But lack of fairness is also evident within countries with members of marginalised groups being disadvantaged compared with their HIV positive counterparts. Studies from different parts of Africa, for example, have shown that men who have sex with men (MSM) are significantly disadvantaged while in the USA and Europe, injecting drug users (IDU’s) will also face additional challenges. In many settings, similar obstacles face male, female and transgender sex workers (Global Commission on HIV and the Law 2012).

If these inequalities are to be tackled, more attention will have to be paid to the social, cultural and economic obstacles facing disadvantaged groups or positive individuals who cannot make their way successfully through what has been called the ‘treatment cascade’ or care continuum.

Who tests and who does not?

The first stage of accessing care is of course testing, and many fall at this early hurdle. A recent estimate suggests that in the most affected African countries, only about 10-12% of people have been tested for HIV and know the result (Obermeyer and Osborn 2007). Worldwide, it is estimated that only about 40% of positive people are aware of their status. This reflects in part the lack of testing facilities. Though the number has increased significantly in recent years they are unevenly distributed with only around 5.5 per 100,000 people in low and middle income countries (WHO, UNICEF & UNAIDS 2011).

But even when facilities are available a wide range of factors may prevent individuals from testing. Of course many will simply be afraid of discovering that they have a serious and potentially fatal illness. But both women and men also report that they are afraid to test on the grounds that if they are found to be positive they may be treated badly by partners, family members and the wider community (Frank 2009).

In most settings women are more willing to be tested than their heterosexual partners. This is partly because they are offered (or required) to test in the context of their use of reproductive services. But it also reflects the reluctance of many men to threaten their masculine identity through appearing weak and vulnerable. As a result many are tested at a later stage than their female counterparts and hence will frequently have a worse prognosis (Skovdal 2011).

A number of studies have also shown that many are reluctant to test because the centres are perceived to be stressful. Most are overcrowded, with staff themselves under huge pressure and too often insensitive to the needs of those they are testing. Service users in many settings have reported a lack of respect as well as a marked lack of confidentiality especially if they test positive (Angotti 2010; Butt 2011).This will of course , be especially problematic in the small close-knit communities where many of the poorest people who are positive struggle to survive. This reluctance to test clearly presents a major obstacle to the success of any drugs based strategy.

What happens after testing?

Even if they are tested there will often be difficulties accessing treatment for those who are found to be positive. While some will have a CD4 count low enough to necessitate the immediate prescription of drugs others may have to wait until their condition worsens. As a result they may be lost to care in the intervening period. And even if treatment is successfully initiated there can be no guarantee that individuals will be willing and/or able to follow medical protocols.

When individuals do drop out of treatment this lack of ‘adherence’ is too often blamed on the individual’s irrationality or lack of will .However recent research has shown that a wide range of economic and social obstacles may face those who have both the need for the drugs and (at least theoretically) the access (Russell et al 2010; Nguyen et al 2007).

Recent US studies have identified the young, the less educated, the poorest, those who are black or Latino and those who do not have medical insurance as being least likely to continue their treatment (Horstmann et al 2010) Injecting drug users too are likely to drop out more frequently. While discrimination may be an important factor, it appears that in most parts of the world it is material and social deprivation that present the single most important obstacle to successful treatment.

Depending on the financial arrangements in place, antiretroviral drugs may be unaffordable for individuals. And even when they are free there may be charges for blood tests or any other treatments needed for opportunistic infections. There have also been a number of reports of corruption in settings where patients are forced to pay bribes (Zimbabwe Lawyers for Human Rights 2010).

As well as the cost of treatment itself the expenses of transportation to the clinic are frequently mentioned as obstacles to sustainability of therapy. Many studies from rural African settings in particular have highlighted the struggles faced by women in their attempts to balance the competing demands of transport, housing and school fees (Tuller et al 2010).

The cost or unavailability of food is also frequently mentioned as an obstacle to appropriate drug use across a range of settings. Lack of food is likely to exacerbate the side effects of ART as well as increasing the patient’s appetite and making them feel hungrier. Thus the medical requirement that the drugs be taken with meals may be impossible to fulfil in situations where food itself is short to come by (Hardon et al 2007).

Managing insecurity

The complexity of these obstacles in what are often very poor subsistence economies may well be exacerbated by the irregular supply of drugs and the lack of choice for service users. Being HIV positive is itself a major cause of insecurity with individuals having little knowledge of if and when their health is likely to deteriorate.

This will frequently be worsened in situations where drug supplies are intermittent as a result of inefficiency in distribution, corruption, social conflict or the natural disasters such as floods or earthquakes that are more common in resource poor settings. Not surprisingly, access to ART is often given little or no attention in the context of such crises yet for individuals it is of critical importance to their survival (Veenstra et al 2010).

A number of studies have shown that harm caused by institutionalised insecurity can be very severe and will often lead individuals to drop out of treatment. While they may begin with hope, this will often be dispelled in the case of drug shortages and lack of appropriate testing and monitoring equipment (Bernays et al 2010).

For many this will be highly stressful with increasing levels of insecurity and uncertainty. Not surprisingly patients find it especially difficult to deal with gaps in treatment or with unexplained changes of drug that appear to have no medical rationale. New combinations are often difficult to get used to and may produce side effects that individuals find unacceptable.

Many service users in situations of dependence also report feeling pressured to change their lifestyle as ‘positive living’ is increasingly stressed by heath workers, policy makers and funders (Nguyen et al 2007). A major requirement will be public disclosure of their status which many will be reluctant to do, having spent much of their time and energy trying to maintain secrecy.

Telling partners can be difficult especially for women who may be afraid of a violent response. For men on the other hand the requirement to ‘live positively’ by avoiding alcohol, cigarettes and unsafe sex may mean the loss of what they perceive as central to their masculinity (Mfecane 2007). For both women and men the requirement to always engage in safe sex may also place major constraints on plans they may have for creating a family (Richey 2006).

It is clear then, that while ART may be effective in ideal circumstances this does not apply to the situation of the majority of HIV positive people in low and middle income countries. As we have seen many have no access at all while others are unable to optimise the potential effects of the therapy as a result of economic and social circumstances as well as the duties, responsibilities and attachments they have to others.

What of the future?

Despite these problems, universalising access to ART remains the central theme of the global response to HIV and AIDS. The notion of ‘Treatment as Prevention’, or TASP, is intended to end the pandemic by ensuring universal access to drugs at an early stage for those diagnosed as positive. It is assumed that this in turn will reduce their infectivity and hence limit the spread to others. But how effective is this likely to be in the wider context of economic recession and growing inequality?

Increased access to treatment will mean a huge increase in the number of people living with HIV who will continue to be in need of drugs throughout their lives. Many will eventually need the much more expensive second and third level drugs. Hence much more investment will be required not just in the production and distribution of drugs themselves but also in the strengthening of health systems and the training and employment of health workers.

However the last few years have seen a continuing decline in available funding. Over the past two decades multilateral, bilateral and philanthropic organisations including The Global Fund, PEPFAR and the Gates Foundation have provided about 60% of all external HIV and AIDS funding to sub-Saharan Africa (Ravishankar et al 2009). The Global Fund has been especially important providing one fifth of all resources for HIV .

The percentage of countries where antiretroviral treatment programmes were adversely affected by reduced external funding rose markedly between 2008 and 2009. Eastern Europe and Central Asia have been particularly vulnerable to the effects of reduced external funding and the economic crisis. Less than a quarter of people in need of treatment in the region are now receiving it with drug stock-outs common and government health expenditure on HIV and AIDS treatment programmes falling sharply.

Not surprisingly the burden of funding is now falling increasingly on individual countries. Domestic spending on HIV care in low- and middle-income countries is already increasing, going from USS$ 3.9 billion in 2005 to nearly $8.6 billion in 2011. Over the next decade the growth rate of a number of the middle income or BRIC countries (Brazil, Russia, India and China) should enable them to meet the needs of their own positive citizens, provided they have the political will to do so.

But the fact remains that for millions of people in the poorest settings, domestic funds will simply not be available. High levels of indebtedness, disadvantageous international trade policies and structural adjustment have limited the volume of national expenditures on health care (AIDS2031 2010). A recent UNAIDS document estimated that the cost of funding HIV treatment will have peaked by 2030 (UNAIDS Fact Sheet 2014). However the coming decades are likely to be ones of increasing need and declining resources.

In the context of growing global inequalities there will inevitably be major questions over the funding of treatment. And even more importantly there is little sign that the lives of those in the greatest poverty will be improved to the point where they can take optimal advantage of available services. Even with improvements in the availability and affordability of antiretroviral drugs, many of those who are HIV positive will not be able to optimise their wellbeing without radical economic and social change (Doyal with Doyal 2013 pp 169-172 and 183-185). Hence optimistic suggestions from New York and Geneva that drugs alone will soon bring an end to the pandemic will need to be treated with the greatest caution.

 

REFERENCES

-AIDS2031 (2010) Taking a Long Term View. London: Financial Times Press
-Angotti N (2010) Working outside the box : How HIV counsellors in sub-Saharan Africa adapt HIV western testing norms. Social Science and Medicine 71 (5) 986-993
-Bernays S & Rhodes T (2009) Experiencing uncertain HIV treatment delivery in a transitional setting: a qualitative study. Aids Care (3) 315- 21
-Butt L (2011) Can you keep a secret? Pretences of confidentiality in HIV/AIDS counselling and treatment in Eastern Indonesia. Medical Anthropology 30 (3) 319-38
-Chan J (2015) Politics in the Corridor of Dying: AIDS activism and global health governance. Baltimore: Johns Hopkins Press
-Frank E (2009) The relation of HIV testing and treatment to identity formation in Zambia. African Journal of AIDS Research 8 (4) 515-524
-Global Commission on HIV and the Law (2012) Rights, Risks and Health. New York: UNDP HIV/AIDS Working Group
-Hardon A et al (2007) Hunger, waiting time and transport costs: time to confront challenges to ART adherence in Africa. Aids Care 19 (5) 658-65
-Horstmann E et al (2010) Retaining HIV infected patients in care: where are we ? where do we go from here? Clinical Infectious Diseases 150 (5) 752-6
-Mfecane S (2011) Negotiating therapeutic citizenship and notions of citizenship in a South African village. African Journal of AIDS Research 10 (2) 129-138
-Nguyen V-K et al (2007) Adherence as therapeutic citizenship: impact of the history of access to anti-retroviral drugs on adherence to treatment. AIDS 21 (supp 5) S31-5
-Obermeyer C & Osborn M (2007) The utilisation of testing and counselling for HIV: a review of social and behavioural evidence. American Journal of Public Health 97 (10) 1762-72
-Ravishankar N et al (2009) Financing of global health: tracking development assistance for health from 1990 to 2007. Lancet 373 (9681) 2113-24
-Richey L (2006) Gendering the Therapeutic Citizen: ARV’s and Reproductive Health. CSSR Working paper no 175 Cape Town: UCT Press
-Russell S et al (2010) Expanding anti-retroviral therapy provision in resource-constrained settings: social processes and their policy challenges. AIDS Care 22 (Supp 1) 1-5
-Skovdal M (et al) 2011 masculinity as a barrier to men’s use of HIV services in Zimbabwe. Globalisation and Health 15 7
-Tuller D et al (2010) Transportation costs impede sustained adherence and access to HAART in a clinic population in southwestern Uganda: a qualitative study. AIDS and Behaviour 14 (4)
-UNAIDS Fact Sheet: Global Statistics 2014
-Veenstra N et al (2010) Unplanned anti-retroviral treatment interruptions in Southern Africa: how should we be treating these? Globalization and Health 6 4
-WHO,UNICEF and UNAIDS (2011) Progress Report : Global HIV/AIDS Response. Epidemic Update and Health Sector Progress Towards Universal Access Geneva: UNAIDS
-Zimbabwe Lawyers for Human Rights (2010) Corruption Burns: Universal access to treatment. Harare ZLHR

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For further elaboration of these ideas as well as a broader commentary on the pandemic see Doyal L with Doyal L (2013) Living with HIV and Dying with AIDS: Diversity, Inequality and Human Rights in the Global Pandemic Ashgate

 

* Lesley Doyal is Emeritus Professor of Health and Social Care at the School for Policy Studies, Bristol University, and has just completed six years as a Visiting Professor at the University of Cape Town. She has published widely in the field of international health and health care with a particular focus on gender. In this capacity she has acted as a consultant for a number of organisations including WHO,UNDAW,Global Forum for Health Research and the British Council.In recent years she has worked extensively in the area of HIV and AIDS using a combination of political economy, ethnographic and intersectional perspectives. Her latest book has been widely acclaimed as the first attempt to provide a global and interdisciplinary approach to life with HIV. Entitled ‘Living with HIV and Dying with AIDS:inequality, diversity and human rights in the global pandemic’ it is published by Ashgate. 

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