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Health Breaking News: Link 236

 

UNITAID CALL FOR PROPOSALS: ‘Supporting access to medicines through innovative use of TRIPS flexibilities’ DEADLINE 17 August 2017 

Winners Of Ideas4Change For UN Sustainable Development Goals 

XVIII International Association for Health Policy in Europe’s (ΙΑΗPE) Conference, 21-24/9, Thessaloniki (Greece) – Call for papers 

Global Policy: Special Issue: Health Care Policy, Resource Allocation and Financial Sustainability 

Health Policy’s Gordian Knot: Rethinking Cost Control 

UN and World Bank sign new partnership to build resilience for the most vulnerable 

World Bank Group, China-led AIIB agree to deepen cooperation 

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General Assembly confirms appointment of Achim Steiner as new UN development chief 

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Africa in the era of sustainable development 

MPP signs licence and technology transfer agreement with Pharco Pharmaceuticals for RAV 

Value-Based Pricing For Pharmaceuticals In The Trump Administration 

A Good Deal For Eliminating Hepatitis C: Saving Money And Lives 

US Department of Defense announces decision to give pharmaceutical corporation exclusive rights on taxpayer-funded Zika vaccine, failing to ensure affordable and sustainable access 

WHO: Hepatitis Death Toll Rising, Vaccination Works But Access To Tests And Medicines Still Issue 

Behind the scenes on new malaria vaccine pilot roll-out 

World Immunization Week: Power of vaccines still not fully utilized, says UN health agency 

Opinion: Embrace the facts — not the myths — about vaccines 

Polio is one step from eradication, and we must take it 

Commitments made on neglected tropical diseases at WHO summit 

Neglected No More 

Neglected No More? The Fight Against NTDs Picks Up 

AMR as a Key Issue for BRICS and Low-Middle Income Countries 

KEI, UACT Request that Trump Administration Reevaluate Xtandi Petition 

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World Bank President Kim: Time to ‘come up with a new plan’ for climate finance 

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As Green Climate Fund Considers Results-Based Payments for Forests, Two Lessons from Earlier Initiatives 

AMR as a Key Issue for BRICS and LMI Countries

Antimicrobial resistance (AMR) poses a serious threat to public health, growth and global economic stability. We affirm the need to explore in an inclusive manner to fight antimicrobial resistance by developing evidence-based ways to prevent and mitigate resistance, and unlock research and development into new and existing antimicrobials from a G20 value-added perspective, and call on the WHO, FAO, OIE and OECD to collectively report back in 2017 on options to address this including the economic aspects. In this context, we will promote prudent use of antibiotics and take into consideration huge challenges of affordability and access of antimicrobials and their impact on public health 

G20 Leaders Communique, Hangzhou Summit 4-5 September 2016, point 46

Garance Fannie Upham

By Garance Fannie Upham

Chief Editor AMR-Times

Geneva, Switzerland

AMR as a Key Issue for BRICS and Low-Middle Income Countries

 

1) The BRICS and LMI countries (Brazil, Thailand, etc.) have recently insisted in WHO fora that the issue of pharmaceutical resistance should not allow global health policy setting to forget ‘access’ because more people die yearly from lack of access to antibiotics than from resistance to medicines. Today this message has begun to be heard : United Nations Access campaign and other fora have revived a worldwide access to medicines campaign.

2) Resistance is a global phenomenon and low income countries and communities will have a harder time facing this problem, especially because of weak health care systems.

3) There is a tendency among doctors treating middle class patients in LMICs to prescribe latest antibiotics because they are informed about the ‘resistance’ issue, so they prescribe strong, last state of the art meds ‘just in case’, but in doing so, they fuel resistance in their own settings. The same error exists, of course, in well-to-do countries.

4) The lack of diagnostic tools, diagnostics laboratories and personnel, means that antibiotics are prescribed needlessly, for example, for children with diarrhea while most of it may be viral or parasitic in origin. And hospitals do not provide the full course of treatment (even when cheap generics are there), forcing poor parents unto the black market where substandard drugs may be offered.

5) To reduce demands on antibiotics in poor countries, the first, essential policy action would be to invest in safe potable water and sanitation. The London School of Economics did a remarkable study (The Impact of Water and Sanitation on Diarrheal Disease Burden and Over-Prescriptions of Antibiotics) on four countries : Brazil, India, Indonesia and Nigeria and their analysis was that close to 500 million cases of childhood diarrhea every year in these 4 countries would be prevented by implementation of WASH (Water- Sanitation- Hygiene), a study commissioned by the UK based Review on AMR (report number 6), March 2016.

6) There is an urgent unmet need for ‘Infection Prevention and Control’, ie patient safety and health care workers safety in health care systems. But no one is putting in the effort. Even in Ebola devastated countries, the funding went to Zika after the Ebola immediate crisis was over, leaving health structures as dirty as before and thus as dangerous in the time of AMR as could be. The WHO DG Dr Chan initiated safe injection campaign a couple of years ago, has been limited to pilots in 4 countries for lack of funding, leaving intact the estimated 6 billion estimated dirty injection practices per year in health care systems. The campaign for ‘Smart (Non-Reusable) Syringes’ will be relaunched at the May 10-12 WHO World Forum on Medical Devices, in Geneva this year.

7) The HIV AIDS epidemic has no end in sight (Cape Town AIDS conference outcome): yet PLWHIVAIDS will be the first affected by AMR, and are already the first to die from AMR because a) opportunistic infections may also be the drug-resistant type b) they will be more at risk from contracting a drug-resistant infection in health care because they will be more frequently in these, c) they are at risk from antiretroviral-resistant HIV (both acquired or health system transmitted). See Nigel Livesley, ASSIST USAID program in AMR Control 2016.

8) The tuberculosis epidemic is wide and continuing and latest estimates of drug resistant TB in India are that real figures are 2 to 3 times higher than reported up to now. (The Lancet, Aug 24th 2016, estimates from drug sales). Yet TB, from India to Eastern Europe, or Greece, is intimately linked with poverty, overcrowded slums, poor nutrition, or helminthic parasitic pollution of the water supply (study in South African slums). Besides better point of care diagnosis for TB and TB drug susceptibility, there is an urgent need for better housing, nutrition, better working conditions for the poor of the world, as well as for the jail inmates. Let us not forget that HIV fuels tuberculosis and that tuberculosis fuels HIV in turn (NIAID 1996)

9) The dumping of untreated waste from antibiotic manufacturing in emerging countries (where most of worldwide medicine production is based) as well as a number of wealthier countries, combined with the dumping of waste from meat and fish industries (both antibiotics residues and meat waste with bacteria resistant to antibiotics) into rivers and soil is a global problem. There is an urgent need for State regulations to forbid this dumping as it is one of the main source for the creation of bacterial genes resistant to antibiotics which have demonstrated the capacity for worldwide travel. There is an urgent need to demand and impose that corporations and manufacturers, as well as hospital structures, use proper technologies to treat their waste and not release them in the environment. Some industries have called for responsibility in this regard (DSM Sinochem). There is an urgent need for cleaner practices and more respect for meat industry workforce as indicated in the new book “Chickenizing”, a first history of food production.

10) While the need for new antibiotics is very real, does it mean that reward for R&D should be equal to the one billion dollar expected income from sales of just one anti-cancer drug or one anti-HIV drug? There is an urgent need to think through a public inter-governmental system to reward public or private innovation in antibiotics with an adequate Prize system. There is also the need to examine the potential of plants (90% of plants used in traditional medicines have not been researched, says Cassandra Quave, Emory University in AMR Control 2016), as well as to invest into R&D in other avenues such as the use of phages (viruses which exist in nature, specific to bacterias). The Pasteur Institute is organizing a Phage day on April 27, 2017.

In the face of this there is, unfortunately, a tendency to ask for extended or even ‘lifelong’ patents, and prices to be multiplied a 10 to 100 fold or more.

OVERALL:

Too many global programs on AMR (most of them, in fact) start with behavior modification:

– patients called ‘users’ should behave better and not ask for antibiotics from prescribers, and should take their prescription to the end (the later recommendation has no scientific basis, except for special long term treatment diseases like tuberculosis);

– doctors should behave better (and prescribe less);

– hospitals should prescribe less (while sometimes their income is related to their sales of meds!),

– veterinarians should prescribe less (but there too, their income may be tied to their sales),

Perhaps, indeed, all true (or most of it).

Yet, the underlying hypothesis is that of the economic ‘free agent’ in the ‘free market’- whereas the response ought to be from the standpoint of public interest and public health.

Doctors must also have a certain degree of freedom and guidelines not put people with co-infections at risk. We need fundamental research on co-infections and take it into consideration in programs (helminths and TB, helminths and HIV, measles and bacteria, etc.)

There is a need to STOP BLAMING THE VICTIM and take public health responsible action.

In the face of AMR the need is for PUBLIC INTEREST INVESTMENTS and orientation: clean environment, access to clean water, stronger and much cleaner health systems, regulations for public health, and stronger investments in public universities basic research.

At the same time, and contrary to the ‘evidence-based’ quick fix and solutions, the issue of AMR poses a challenge to the health system as a whole.

There is an urgent need to develop a ‘patient based system’, which does not mean one where the patient is treated as a mythical ‘free consumer’ but, rather, a 21rst century science based health system which goes to the patient instead of demanding that the patient travel to treatment in LMICs.  With internet, video capsules in gastroenterology, ambulatory surgery, diagnostic at the point-of-care and from a distance, clean water generation, solar and other electricity producing innovations, we could envision a very modern form of primary and secondary health care:

AMR poses that global challenge: implementing the Right to Health for All.

Health Breaking News: Link 235

Health 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

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IMF: Global economy has ‘spring in its step’ but protectionism fears loom 

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The World Bank’s new CEO Kristalina Georgieva lays out her vision for an agile bank 

Progress toward Universal Financial Access 

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The Future Of Investment In PEPFAR: Understanding PEPFAR’s Multiple Economic, Health, And Diplomatic Impacts 

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Fertility apps: The ‘next wave’ in solving global family planning crisis 

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New publication by TWHA and PHM: Building a movement for health – a tool for (health) activists 

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New figures show the poorest countries could miss out due to weak aid rules 

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New Tools Needed to Fight Ancient Disease 

Personalised cancer treatment gets more specific 

The Ebola Crisis: Lessons Learned for Developing Nations 

How to Improve Access to Malaria Treatment in the Private Sector 

Treatment Affordability and the Entry of Biosimilars 

Is There a Fair and Equitable Access to Safe Blood Transfusion Products in the World? 

U.S. defunds U.N. Population Fund, cutting health services to 9 million people 

Parliament calls for mandatory EU-wide food waste targets by 2020 

New Large-Scale Initiative Aims To Increase Open Access To Scholarly Research 

World Bank: Latin America needs smarter investments in sanitation, transport 

Human Rights Reader 411

Treatment Affordability and the Entry of Biosimilars

Uptake of biosimilars, i.e. cost saving highly similar versions of the stiff price reference biologic products, has been slow throughout most of Europe and the rest of the world. 
Without express and official government policy purchasing and recommending biosimilars, doctors will not use biosimilars and the resulting cost savings cannot be made

Fifa Rahman

By Fifa Rahman*

Postgraduate Researcher, University of Leeds, UK

Treatment Affordability and the Entry of Biosimilars

Brief reflections on the 15th Biosimilar Medicines Conference in London, 23-24th March 2017

 

Biologics, i.e. medicines that are engineered from living cells, are dominating the pharmaceutical market, with 9 out of the 10 top-selling medicines being biologic, and accounting for $70.2 billion in revenue. (Brown, 2016, p. 5) Being complex to manufacture, and being subject to arbitrary price gouging, the prices of biologics are very high and are beyond the reach of a majority of patients. However, the market is now facing the first biologics patent cliff, with many biosimilars now entering, resulting in the opportunity for governments worldwide to make real cost savings. However, uptake of biosimilars, i.e. highly similar versions of the reference biologic product, has been slow throughout most of Europe and the rest of the world.

image fifa's article 2017

On 23-24th March 2017, I attended the 15th Biosimilar Medicines Conference in London, in order to better understand the current biosimilars market, and to help elucidate questions I had about slow uptake. A couple of presentations were of particular interest.

The Norwegian success story on substitution of biologics with biosimilars is distinct from the reality in most countries worldwide. Dr Steinar Madsen of the Norwegian Medicines Agency related the cost imperative of substitution of novel infliximab in Norway with the corresponding biosimilar, citing government incentives to doctors as the key to the success. In 2 years of the new policy, the biosimilar infliximab had garnered 92.9 per cent of the market share in Norway. (Welch, 2016)

Infliximab, a highly effective monoclonal antibody targeting Crohn’s disease, ulcerative colitis, and rheumatoid arthritis, among other conditions, costs up to £420 per vial, and since treatment dose is dependent on weight, a singe dose of treatment for someone weighing 73kg, for example, would cost £1680 (Robertson, 2015), with approximately 8 doses needed annually. White (2016) reports that use of biosimilar infliximab cuts the course of an annual course of treatment from £10,000 down by half, resulting in substantial cost savings for governments.

Doctors elsewhere, including many middle-income countries where disease burdens are increasingly mirroring that of developed countries, have been suspect of biosimilars substitution, on unfounded grounds that they have reduced safety and efficacy. This is contrary to all recent evidence and developments in Europe, where European medicines authorities have reacted positively to biosimilar medicines interchangeability (Baumgärtel, 2017). In addition to Norway, in Denmark, as related by a conference participant, biosimilar infliximab has wiped out originator infliximab, and 50% more patients are being treated.

So how do governments encourage doctors to substitute reference biologics with biosimilars? According to an earlier presentation at the conference by Per Troein from Quintiles IMS, “Biosimilars uptake is highly dependent on government proactivity in encouraging hospitals and physicians to substitute.” That is to say, without express and official government policy purchasing and recommending biosimilars, they will not use biosimilars and the resulting cost savings cannot be made.

The entry of biosimilars, including the projected entry of Roche’s Ocrevus (multiple sclerosis) and Sanofi’s Dupilumab (atopic dermatitis) in 2017 (Brown, 2016, p. 8), is bound to result in a corresponding response in terms of maximalist intellectual property. Proponents contend that market exclusivity periods for reference biologics are too short, as even if the pioneer biologic retains substantial market share after biosimilar entry, that biologic would fail to recover the average costs of development, manufacturing, promotion, and the cost of capita. (Grabowski et al., 2011, p. 15) The U.S. Federal Trade Commission has disagreed with the contention that patents provide insufficient protection, contending that biologics are covered by varied, and more complex, patents. These considerations are relevant for governments considering the way forward in the Trans-Pacific Partnership, which contains 5 or 8 years of market exclusivity for biologics as a minimum standard.

Also interesting during the conference were discussions around narrow bolar exemptions as a barrier to biosimilar medicines entry in Europe. Broader bolar exemptions ensure that experimentation and clinical trials conducted in the private domain towards the production of biosimilars can occur.

As countries get richer, disease burdens in developing nations mimic and morph closer to those of developed nations, and at the same time that they set aside misconceptions and embrace biosimilars as have some European countries, they will be expected to embrace maximalist intellectual property tailored towards extending the monopolies of biologic medicines. And while the countries themselves may be rich per World Bank standards, this does not reflect purchasing power, nor does it necessarily reflect the strains on health budgets. Only time will tell how developing countries and emerging markets respond to these countervailing interests, but in any case will serve to illuminate and elucidate the mechanics of the new pharmaceutical political economy and its impact on access to medicines.

 

References

Baumgärtel, C. 2017. Austrian medicines authority positive towards biosimilar interchangeability. GaBi Journal [Online]. 6 [Accessed 24 March 2017]. Available from: http://gabi-journal.net/austrian-medicines-authority-positive-towards-biosimilar-interchangeability.html

Brown, A. 2016. EP Vantage 2017 preview. London: Evaluate Group Ltd [Online]. [Accessed 1 March 2017]. Available from: http://info.evaluategroup.com/rs/607-YGS-364/images/EPV2017Prev.pdf

Grabowski, H., Long, G., Mortimer, R. 2011. Data exclusivity for biologics. Nature Reviews Drug Discovery. [Online]. 10: 15-16. [Accessed 20 March 2017]. Available from: http://www.nature.com/nrd/journal/v10/n1/full/nrd3277.html

Robertson, S. Infliximab cost. [Accessed 9 April 2017]. Available from: http://www.news-medical.net/health/Infliximab-Cost.aspx

Welch, A. R. 2016. The Norwegian biosimilar phenomenon: from biosimilar to biogeneric. Biosimilar Development [Online]. 26 July [Accessed 23 March 2017]. Available from: https://www.biosimilardevelopment.com/doc/the-norwegian-biosimilar-phenomenon-from-biosimilar-to-biogeneric-0001

White, C. Infliximab biosimilars are safe, effective, and cheap, UK audit shows. British Medical Journal. [Online]. 354 [Accessed 9 April 2017]. Available from: http://www.bmj.com/content/354/bmj.i5084

——————-

*Fifa Rahman, MHL (Health Law) is pursuing a PhD in Law examining political economy tradeoffs to intellectual property demands in trade agreements, in the context of access to biosimilars. She is contactable at f.rahman1@leeds.ac.uk.

 

 

Is There a Fair and Equitable Access to Safe Blood Transfusion Products in the World?

Blood transfusions are today safer than any other treatment procedures today in the richest part of the world. But it is less true elsewhere, where the role of unsafe blood transfusions on major dramatic epidemic situations is certainly high although not so well documented: hepatitis B and C and E... and even HIV
...it is estimated by WHO (The World Health Organization) that up to 80% of the world population who need safe blood products don’t get them

Yves Charpak

By Yves Charpak*

MD, Public Health Specialist, PhD in Epidemiology

Is There a Fair and Equitable Access to Safe Blood Transfusion Products in the World?

 

We all have in mind historical images of people being saved from death through blood transfusions after accidents, wounds, deliveries, hematological diseases… It is still true in numerous medical situations, but unfortunately it is estimated by WHO (The World Health Organization) that up to 80% of the world population who need safe blood products don’t get them.

We also know that blood transfusion may be dangerous through transmission of various micro-organisms. There were major crisis in Europe and other developed health systems, leading to “the blood contaminated scandals” in the years  80-90. Theses crisis have been sources of major changes in the blood transfusion systems in the most developed countries. Major surveillance systems have been put in place for making sure that the threatening nosocomial diseases like transmission of HIV and hepatitis through blood transfusions are under control. It is fragile but a big success. Blood transfusions are today safer than any other treatment procedures today in the richest part of the world.

But it is less true elsewhere, where the role of unsafe blood transfusions on major dramatic epidemic situations is certainly high although not so well documented: hepatitis B and C and E… and even HIV…

A huge burden of disease in emerging and developing countries is on its way on hepatitis. In the former especially, because the increase in life expectancy will allow existing chronic hepatitis infections to develop toward cirrhosis and liver cancers in the future.

HIV is a worldwide concern, but even the numerous international or bilateral aid institutions specialized on HIV – UNAIDS, GFATM, UNITAID, WHO, EU, PEPFAR, etc.- are not addressing seriously the transmission of the virus through blood transfusions. And hepatitis are only considered as “co infection” problems.

The international “solution” for hepatitis can be seen through GAVI programs (Global Alliance for Vaccines and Immunization). GAVI intends to vaccinate massively young children against hepatitis B (therefore children will not get it in the future, even if exposed to it). Hepatitis C is more and more covered through patents agreements to provide worldwide antiviral treatment for hepatitis C.

But a worldwide strategy to prevent what is probably, at least partly, a major nosocomial problem linked to blood transfusions is yet to be seen.

Could blood transfusion lack of products be considered as an “orphan disease” ?

WHO has been for long advocating for safe ad sufficient blood transfusion…

Blood transfusion products have been put recently on the list of essential drugs of WHO.

The introduction of “labile blood products” (LBP; the red cells, the platelets and the plasma for transfusion) on the list was opposed by a lot of the blood transfusion institutions in the developed world, because they consider themselves as not being part of the “medicine system”. Therefore there is no international trade of blood products for transfusion (LBP).

It is important to mention that this article is not addressing another part of the blood products which is the transformation of some collected plasma into “pharmaceutical drugs”, called the PMD, Plasma Derivated Drug.

The situation regarding the blood products for transfusion (LBP) is that the blood banks, being out of the “Medicine industry”, have their own system of quality and Good Manufacturing Practices. This situation protects them from the worldwide trade of medicinal products. Most developed countries are “self-sufficient” and don’t allow usually import of products. It fits well with WHO recommendations, advocating for country self-sufficiency worldwide based on non-paid donations (Voluntary Non-Remunerated Donations, VNRBD).

This is “value based” and very nicely in line with most international or regional human right treaties.

But real life is challenging this value based policy. There is no visible timeline for the achievement of a perfect solution. In between, waiting for success of the ideal policy, the situation of shortage of safe products is creating favorable environment for future health problems which is not addressed properly.

As no specific international aid program is supporting all countries to achieve quickly their expected self-sufficiency in the coverage for blood transfusion products, the situation is dramatic in many places, when looking at WHO description of the situation with a reverse view: looking at the gaps instead of the improvements provides the real situation (http://www.who.int/mediacentre/factsheets/fs279/en/).

WHO text is in italic and between quotes.

«The risk of transmission of serious infections, including HIV and hepatitis, through unsafe blood and chronic blood shortages brought global attention to the importance of blood safety and availability. With the goal of ensuring universal access to safe blood and blood products, WHO has been at the forefront to improve blood safety and availability, and recommends the following integrated strategy for blood safety and availability: »

Types of blood donors

«There are 3 types of blood donors:

  • voluntary unpaid
  • family/replacement
  • paid.

An adequate and reliable supply of safe blood can be assured by a stable base of regular, voluntary, unpaid blood donors. These donors are also the safest group of donors as the prevalence of bloodborne infections is lowest among this group»

« Data reported to WHO shows significant increases of voluntary unpaid blood donations in low- and middle-income countries: »…

BUT,

« In 72 countries, more than 50% of the blood supply is still dependent on family/replacement and paid blood donors (11 high-income countries, 45 middle-income countries and 16 low-income countries) »

Family/replacement donors are often the only way for a patient to get blood transfusion: if a patient needs a transfusion, he would (or his family) bring a donor, wherever they find him/her, to replace the products that will be used. And sometimes they just directly pay for “professional” donors outside the facility, even not knowing them…

And there are also blood banks getting donations through paid donors. For most of those paid donors the payment may be the only resource available, leading them to put in danger their own health by repeating it too often. And for the blood bank and the recipient patients it leads to more risky donations. Especially if no proper testing is available.

Blood screening

« WHO recommends that all blood donations should be screened for infections prior to use. Screening should be mandatory for HIV, hepatitis B, hepatitis C and syphilis. Blood screening should be performed according to the quality system requirements. »

BUT

  • « 16 countries are not able to screen all donated blood for 1 or more of the above infections.
  • Irregular supply of test kits is one of the most commonly reported barriers to screening.
  • 81% blood screening laboratories in high-income countries are monitored through external quality assessment schemes, as compared to 55% in middle-income countries and 34 % in low-income countries.
  • The prevalence of transfusion-transmissible infections (TTI) in blood donations in high-income countries is considerably lower than in low- and middle-income countries ».

Safety of use:

« WHO recommends the development of systems, such as hospitals transfusion committees and haemovigilance, to monitor and improve the safety of transfusion processes. In this regard: »

  • « 125 countries (Among 194 WHO Member States) have national guidelines on the appropriate clinical use of blood.
  • Transfusion committees are present in 67% of the hospitals performing transfusions in high-income countries and in 34% of the hospitals in middle- and low- income countries.
  • Clinical audits are conducted in 54% of hospitals performing transfusion in high-income countries and in 42% of hospitals in the middle- and low- income countries.
  • Systems for reporting adverse transfusion events are present in 92% of hospitals performing transfusion in high-income countries and 40% in middle- and low- income countries.
  • 72% of high-income countries have a national haemovigilance system, compared to only 28% of middle- and low-income countries. »

« In high-income countries, transfusion is most commonly used for supportive care in cardiovascular surgery, transplant surgery, massive trauma, and therapy for solid and haematological malignancies. In low- and middle-income countries it is used more often to manage pregnancy-related complications and severe childhood anaemia. »

To conclude, WHO is one of the only international organizations advocating for sufficient and safe blood products worldwide, with almost no resources allocated for implementing related programs.

But the present situation shows that the expectations of the advocated policies are far from being achieved in many emerging and developing countries, creating a dangerous situation for the future: a huge burden of disease for tomorrow is being created today, but invisible to major international aids’ agendas.

The crisis which occurred in Europe and developed countries, named “contaminated blood scandals”, may well pop up in most countries tomorrow. The developed world leading the agenda on international aid will have its own responsibility in not trying to address it:

– Reinforcing the international support to WHO recommendations by giving more focus on building safe blood transfusion systems everywhere.

– Making sure that all health facilities in the word where blood transfusion products are needed for patients get it, whatever that means. It could well include international circulation of safe blood transfusion products (LBP) at affordable prices for poor countries.

– As most blood donations are done in the developed world today, could those genuine and generous donors give a bit more for helping poorest part of the world get the blood products they need, waiting for them to be self-sufficient? It would be a shift in blood donation policies in our rich countries… but potentially very rewarding.

 

—————————————–

*Yves Charpak is a public health MD with a PhD in Epidemiology. From 1981 to 2000 He worked as a researcher in Health technology Assessment (HTA) and clinical epidemiology, and then as consultant in evaluation of health systems in his own company (EVAL). He then moved from 2000-2007 to WHO regional office for Europe as senior policy advisor to the Regional Director. Then he was back to France as head of international affairs of Institut Pasteur, followed by head of prospective studies in the French blood transfusion systems (EFS) and its representative in European Blood Alliance (vice-president of EBA).

He is member of various think tanks on health and vice president of the SFSP (Société Française de Santé Publique).

He writes and talk on health issues in journals, papers and social media.

He wrote a book in 2016 with his former Director of WHO regional Office, Marc Danzon: “La santé dans l’arène politique mondiale”, Editions Belin, Paris

 

 

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TURTLE

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Oxford University Press Textbook of Global Health (4th edition, 2017) co-authored by Anne-Emanuelle Birn, Yogan Pillay, and Timothy Holtz 

Links to PEAH latest publications 

Clean seas: turn the tide on plastic 

World Ocean Summit 2017 

Only healthier diets can tackle climate change, experts claim 

WHO: public health round up 

Scale up of hepatitis C treatment possible as Brazil rejects patent on key drug 

Report Finds Wide Gap In Pharma Companies’ Profits And Spending On R&D

A Strategy For Lowering Brand Drug Prices: Patent Buyouts And Licensing 

Strategies To Address The Challenges Of Outcomes-Based Pricing Agreements For Pharmaceuticals 

New Drug Pricing Bill from Democrats Balances Innovation, Access 

Modernizing And Strengthening Existing Laws To Control Drug Costs 

Report: Market Share Of Orphan Drugs Could Top 20 Percent Of Global Market By 2022 

Never Say Die: How State Health Funders Are Defending Obamacare 

Leapfrogging the Cold Chain: Why Gates is Big Into Microneedles 

Pandemic response a cycle of ‘panic and neglect,’ says World Bank president 

Progress in promoting data sharing in public health emergencies

Reflections on governance and corruption at the 2017 AAC 

The Campaign to Lead the World Health Organization 

A Race To Restore Confidence In The World Health Organization 

Antibiotic-Resistant ‘Superbugs’ Are Here 

Antimicrobial resistance: translating political commitment into national action 

UNAIDS WARNS THAT COUNTRIES WILL MISS THE 2020 TARGET OF REDUCING HIV-ASSOCIATED TB DEATHS BY 75% UNLESS URGENT ACTION IS TAKEN 

Status and methodology of publicly available national HIV care continua and 90-90-90 targets: A systematic review 

PLOS Medicine Special Issue: Advances in HIV Prevention, Treatment and Cure 

Global health: a midlife crisis, early retirement, or growing pains? 

Social innovation for health-care delivery in Africa 

Lessons learnt from 12 oral cholera vaccine campaigns in resource-poor settings 

New Development Bank and EIB Sign Memorandum of Understanding to Structure Future Cooperation 

UNPO newsletter March 2017 edition 

S20 DIALOGUE FORUM Experts discuss global health 

 

Links: PEAH latest publications

PEAH6

Links to PEAH latest publications

 

medusa

AFEW-Tajikistan Has Unique HIV Rapid Testing Point in the Country

by Olesya Kravchuk, Communications Officer at AFEW (AIDS Foundation East-West) International

Tajikistan is among the countries where HIV prevalence has increased by more than 25% over the last 10 years. In Tajikistan the number of sterile needles and other commodities for people who inject drugs per year is still very low. AFEW-Tajikistan is the only NGO in the country that has HIV voluntary counselling and rapid testing

http://www.peah.it/2017/03/3894/

PEAH

Public-private Partnership Paradox: the Case of Gavi and Health System Strengthening

by Renée de Jong, Junior Global Health Advocate at Wemos Foundation

The WHO model for Health System Strengthening (HSS) includes improving its six health system building blocks and managing their interactions in ways that achieve more equitable and sustained improvements across health services and health outcomes.... It appears that Gavi maintains a very different interpretation of HSS....vhere the interconnectedness between the building blocks is hardly taken into account

http://www.peah.it/2017/03/public-private-partnership-paradox-the-case-of-gavi-and-health-system-strengthening/

PEAH4

Inclusive Communication as a Mechanism to Improve Equity of Access in Health Systems

by Alex Henriquez Research Analyst at Healthcare Improvement Scotland / Scottish Health Council

 A really equitable health system is that that ensures that people with special needs also have fair access to healthcare. This is especially relevant for people with communication needs, who may experience more barriers of access to healthcare services. Inclusive communication is an approach to communication in which information and its understanding are made accessible to everyone 

http://www.peah.it/2017/03/inclusive-communication-as-a-mechanism-to-improve-equity-of-access-in-health-systems/

DSCN0524 Creating and Maintaining Fair, Trustworthy and Sustainable Research Collaborations

by Lauranne Botti, Manager and Carel Ijsselmuiden, Executive Director COHRED’s Research Fairness Initiative (RFI), The Council on Health Research for Development-COHRED Group Geneva, Switzerland

 The Research Fairness Initiative (RFI) responds to the increasing understanding of the importance of partnerships and SDG 17 by ensuring that institutions around the world can have access to an evidence-base on how to create and maintain fair, trustworthy and equitable partnerships in research and innovation 

http://www.peah.it/2017/03/creating-and-maintaining-fair-trustworthy-and-sustainable-research-collaborations/

stella marina

From Animosity to Murder: the Spectrum of Workplace Violence against Physicians

by Lawrence C. Loh, Dalla Lana School of Public Health, University of Toronto, and Director of Programs at The 53rd Week Ltd

 The observed increase in violence against physicians is a clear trend, supplemented by no end of anecdotal stories of physician disrespect; spitting, verbal, and physical assault, online harassment. Many of these would be criminal if done against a transit operator, but such behaviour seems to be increasingly tacitly accepted as part of a doctor’s craft

http://www.peah.it/2017/03/from-animosity-to-murder-the-spectrum-of-workplace-violence-against-physicians/

pesce ali

Taking a Pill: Not So Counted On in South Africa

by Pietro Dionisio, EU health project manager at Medea SRL, Florence, Italy. Degree in Political Science, International Relations Cesare Alfieri School, University of Florence, Italy

 Despite noteworthy improvements in its public health system, South Africa is still facing huge problems in fighting diseases such as TB  and HIV/AIDS. Among several reasons, the poor patient adherence to medical prescription stands out.  Though the Government is trying to address the issue, the desirable results still lag behind. Future years look brighter than today’s, but additional efforts are required to pull the final goal off

http://www.peah.it/2017/02/taking-a-pill-not-so-counted-on-in-south-africa/

205

Substantive Work of WHO, particularly in  Relation to Health Systems Development, Should Counter the Privatization Agenda, but Does It?

by Claudio Schuftan, People’s Health Movement – PHM

 Donor countries (the US in particular) continue to push WHO towards working with industry through ‘multistakeholder partnerships’, rather than giving WHO the chance to implement regulatory and fiscal strategies that could make a real difference. (David Legge) Moreover, bilateral donors (and big philanthropies) demand WHO provides data according to their particular interests. Therefore, the types of data produced by WHO (and other UN agencies) are greatly influenced by a donor mandate that goes beyond the simple compilation of country-reported statistics 

http://www.peah.it/2017/02/3736/

TURTLE

Do the Credit Policies of the WB, IMF & EC Damage Health?

by  Daniele Dionisio, PEAH – Policies for Equitable Access to Health

article originally published in International Health Policies http://www.internationalhealthpolicies.org/do-the-credit-policies-of-the-wb-imf-ec-damage-health/

Despite recent positive rhetoric by the IMF, WB and the EC to reform conditionality policies, a gap persists between the declared intentions and the general practice. It is time for the three institutions to turn the rhetoric into reality 

http://www.peah.it/2017/02/3713/

PICT2797-300x225

Brexit can be Hazardous to our Health

by Ted Schrecker, Professor of Global Health Policy, Durham University, UK

 ...health researchers and professionals are (or should be) asking how Brexit will, and could, affect public health.  Among the questions, informed by a political economy perspective on health and its social determinants, five stand out.One needs to remind oneself that the last word in Albert Camus’ famous essay about suicide is ‘hope’.  But it is hard to sustain in these times 

http://www.peah.it/2017/01/brexit-can-be-hazardous-to-our-health/

DSCN1778

Could HIV be the Youngest Disease to be Eliminated? The Experience of Ethiopia

by Taye Tolera Balcha, MD, MPH, PhD, Director General, Armauer Hansen Institute (AHRI)

 Excellent partnership between the government, key stakeholders, and the community has helped Ethiopia rise to the tectonic challenge of HIV. Since 1990, more than 90% reduction in new HIV infection has been recorded. Survival of HIV-positive individuals has substantially improved. At present, about 70% of HIV-positive people in the country know their status and 65% are on treatment 

http://www.peah.it/2016/11/could-hiv-be-the-youngest-disease-to-be-eliminated-the-experience-of-ethiopia/

pesce

Kenya in a Bad Shape about Open Defecation Free Goal

by Pietro Dionisio, Degree in Political Science, International Relations Cesare Alfieri School, University of Florence, Italy

 Even though the national law establishes the right to “reasonable standards of sanitation”, some Kenyan people are denied them. Especially in rural areas, the worst-off people face poor living conditions due to open defecation. The Government is implementing a four year strategy to fight against this scourge, but corruption, misappropriation and mismanagement risk to frustrate the efforts 

http://www.peah.it/2016/11/kenya-in-a-bad-shape-about-open-defecation-free-goal/

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Antibiotico-resistenza: la risposta OMS

 "Antibiotic resistance is growing, and we are fast running out of treatment options. If we leave it to market forces alone, the new antibiotics we most urgently need are not going to be developed in time." 

 Marie-Paule Kieny, WHO's Assistant Director-General for Health Systems and Innovation

 MINOLTA DIGITAL CAMERA

By Daniele Dionisio

Membro, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

Responsabile del Progetto Policies for Equitable Access to Health – PEAH http://www.peah.it/

  Antibiotico-resistenza: la risposta OMS 

 

Un problema multifattoriale

La resistenza dei batteri agli antibiotici è un fenomeno in rapida crescita, come confermato, su scala mondiale, dal Surveillance Report OMS del 2014.

Esposti a particolare rischio sono i pazienti ospedalizzati lungodegenti, soprattutto se richiedenti procedure invasive multiple o pluri-antibiotico terapie, inclusi gli ustionati gravi e gli immunodepressi in generale, per i quali è elevata la possibilità di sviluppare infezioni sistemiche da germi multi-resistenti.

E mentre i paesi ricchi, grazie a sistemi sanitari stabili e avanzati, possono meglio affrontare il problema, questo si preannuncia drammatico nei paesi poveri.

La criticità è ingigantita dal fatto che lo sviluppo industriale di nuovi classi di antibiotici ha mostrato una preoccupante flessione negli ultimi decenni.

Non è un mistero che l’industria sia incentivata ad investire nello sviluppo di nuovi farmaci per patologie croniche piuttosto che per quelle infettive (solitamente di breve corso), in ordine ai ritorni economici di ben più lunga, spesso pluriennale, durata.

Ma l’antibiotico-resistenza affonda in molteplici cause che ne compongono la natura multifattoriale e favoriscono, attraverso la non necessaria esposizione a plurimi antibiotici, la selezione di ceppi batterici resistenti. Fra queste:

-Prescrizioni irrazionali o inutili da parte dei medici, ovvero impiego di antibiotici ad ampio spettro laddove basterebbe uno spettro ristretto e mirato.

-Vendita senza ricetta, soprattutto diffusa nei paesi in via di sviluppo, di antibiotici da banco presso farmacie e mercati, oltre che via internet.

-Trasmissione paziente-paziente intraospedaliera di patogeni multi-resistenti in carenza di adeguate misure igieniche e di controllo delle infezioni.

-Impossibilità di sorveglianza e monitoraggio delle resistenze  in molte aree in via di sviluppo per la scarsità o assenza di laboratori in grado di testare campioni biologici di pazienti per saggiare la resistenza microbica ai farmaci.

-Diffuso e incontrollato impiego di antibiotici in agricoltura e nella filiera animale del commercio.

OMS in azione

Il 27 febbraio 2017 l’agenzia OMS pubblicava la ‘Global Priority List of Antibiotic-Resistant Bacteria’ nell’intento di guidare e promuovere la ricerca e sviluppo (R&D) di nuovi antibiotici in linea con quanto dalla stessa e dalle Nazioni Unite già prodotto, inclusi la ‘Political Declaration on Antimicrobial Resistance’ e  il ‘Global Action Plan on Antimicrobial Resistance’.

La lista evidenzia in particolare la minaccia dei batteri gram-negativi multi-resistenti agli antibiotici e di cui è nota la capacità trasmissiva di materiale genetico ad altri batteri così da trasformarli in germi a loro volta antibioticoresistenti.

La lista è suddivisa in tre categorie in rapporto all’urgenza di nuovi antibiotici: critica, alta, e media priorità.

Il gruppo a priorità critica comprende agenti antibiotico-resistenti (incluso a carbapenemi e cefalosporine di terza generazione) particolarmente temibili in ospedali, case di riposo, e in pazienti richiedenti ventilatori e cateteri endovenosi, quali responsabili di infezioni severe e potenzialmente letali del distretto circolatorio e respiratorio.

La tubercolosi, pur con nota resistenza in crescita ai farmaci tradizionali, è stata esclusa dalla lista perché oggetto di programmi specifici.

Di seguito i criteri di selezione dei patogeni inseriti: potenziale letalità delle infezioni correlate; necessità di ospedalizzazione dei pazienti colpiti; frequenza di resistenza agli antibiotici correnti nel caso di pazienti ospiti di comunità; grado di diffusibilità tra animali, da animali a uomo, e da persona a persona; possibilità di prevenzione (es. mediante igiene adeguata e vaccinazione); opzioni residue; idonei nuovi antibiotici già in corso di ricerca e sviluppo.

La lista intende spronare i governi ad attuare politiche incentivanti la scienza di base e lo sviluppo di nuovi antibiotici tramite il coinvolgimento di agenzie a finanziamento pubblico e del settore privato. Da menzionare, quale esempio applicativo corrente, è il nuovo partenariato ‘WHO/Drugs for Neglected Diseases initiative (DNDi) Global Antibiotic R&D’ mirato allo sviluppo ‘no profit’ di nuovi antibiotici.

Un approccio allargato

Se maggiore ricerca e sviluppo è vitale, da sola non può risolvere il problema. Allo scopo il ruolo proattivo di governi e istituzioni regolatorie è irrinunciabile, incluso per l’ottimale coordinamento fra le parti senza duplicazioni o sovrammissioni di iniziative.

Non è dunque per caso che, in accordo con quanto previsto nella citata ‘Political Declaration’, le Nazioni Unite hanno annunciato il 17 marzo scorso l’insediamento del ‘Coordination Group on Antimicrobial Resistance’ incaricato di fornire una guida pratica agli approcci necessari per assicurare azione globale, sostenibile ed efficace contro l’antibiotico-resistenza, compresa ogni opzione per migliorare i livelli di coordinamento.

Il Gruppo, co-diretto dal vice-segretario  generale delle Nazioni Unite e dal direttore generale OMS, è composto da rappresentanti delle agenzie correlate e di altre organizzazioni internazionali, oltre ad esperti di settore.

Ovviamente, questo non può bastare. Per contrastare l’antibiotico-resistenza occorre migliore prevenzione delle infezioni, uso appropriato, in animali e uomo, degli antibiotici esistenti ed impiego razionale di ogni nuovo antibiotico.

In sintesi, oltre allo sviluppo di nuovi antibiotici, altre contemporanee azioni urgono:

  • Migliore prevenzione e controllo delle infezioni, in particolare per i degenti ospedalieri;
  • Migliore accesso a laboratori di microbiologia affidabili per incrementare la sorveglianza e tracciare lo spettro dell’antibiotico-resistenza in contesti definiti;
  • Formazione degli operatori sanitari e dei medici sull’uso degli antibiotici al fine di pratiche prescrittive e di controllo antinfettivo adeguate e razionali;
  • Attività di advocacy e correlata ricerca operativa;
  • Collaborazione stretta con ministeri della salute e governi locali per ridurre la disponibilità da banco degli antibiotici a largo spettro, assicurando nel contempo che quanti in necessità di antibiotici li possano tempestivamente ricevere;
  • Collaborazione stretta con ministeri della salute e governi locali per l’espansione della pratica vaccinale quale strategia di contrasto alle malattie che richiedono antibiotici.

 

PER APPROFONDIRE

WHO: Global Priority List of Antibiotic-Resistant Bacteria http://www.who.int/medicines/publications/WHO-PPL-Short_Summary_25Feb-ET_NM_WHO.pdf

UN: Political Declaration on Antimicrobial Resistance http://www.un.org/en/ga/search/view_doc.asp?symbol=A/RES/71/3

Antimicrobial resistance: translating political commitment into national action http://www.who.int/bulletin/volumes/95/4/17-191890/en/

Antimicrobial resistance: global WHO report on surveillance 2014 http://www.who.int/drugresistance/documents/surveillancereport/en/

Global Antibiotic Research and Development Partnership (GARDP) garners key financial support for launch https://www.dndi.org/2016/media-centre/press-releases/gard-garners-key-support-for-launch/

WHO: Global Action Plan on Antimicrobial Resistance http://www.wpro.who.int/entity/drug_resistance/resources/global_action_plan_eng.pdf

MSF takes on antibiotic resistance https://www.msfaccess.org/content/msf-takes-antibiotic-resistance