May 2013 – PEAH – Policies for Equitable Access to Health

EU Trade Agreements: Favouring Big Pharma over public health

In recent years, the European Union (EU) has been aggressively pushing for Intellectual Property (IP) provisions in bilateral trade agreements with emerging economies such as India and Thailand. These trade agreements are designed to ensure that developing countries who sign these agreements adopt more stringent IP laws that go much beyond the requirements of the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights agreement.

The Government of India and Thailand should ensure that negotiations that affect public health must be conducted with adequate levels of transparency and public scrutiny, and access to the negotiating texts must be increased. They should also ensure that public interest does not get overshadowed by commercial interest as failure to do so will cut have dire consequences for access to medicines for millions

EU Trade Agreements: Favouring Big Pharma over Public Health

Chalermsak Kittitrakul* and Shailly Gupta**

*Coordinator, AIDS ACCESS Foundation (Thailand)

**Policy Advocacy Officer, Médecins Sans Frontières Access Campaign (India)

The intent behind this approach is clear: Proposed EU Trade agreements seek to further consolidate and extend the monopolies of big pharmaceutical companies by blocking the production, registration and supply of affordable generic medicines.

The increased availability of affordable generic medicines played a key role in scaling up treatment of HIV/AIDS around the world, allowing for nine million people to be on treatment today. Competition among generic producers was instrumental in bringing down the price of the first generation of ARVs, and is one of the key reasons treatment could be scaled up to millions of people. Today, first-line ART is available for as little as $100 per person per year (ppy), which is a 99% decrease from 2000, when treatments still under patent were priced at more than $10,000 ppy.

In particular production of low cost, quality generic drugs by Indian manufacturers – in the absence of patent barriers – has made the country the ‘pharmacy of the developing world’ with supply of affordable essential medicines, vaccines and medical products reaching more than 100 countries. Many large non-profit organisations that procure medicines for treatment across the world, including UNICEF, UNFPA, PEPFAR, Global Fund, UNITAID and IDA [1] , largely depend on generic medicines from India. For example, over 70 percent of all pharmaceuticals and 100 percent of paediatric and second-line antiretroviral medicines (ARVs) bought by IDA are procured from Indian companies.

But the situation today is different and the progress achieved is once again under threat. With the WTO’s TRIPS agreement being implemented in key manufacturing countries and several of the newest drugs for cancer, TB, HIV and hepatitis are now patented in countries such as India and Thailand. The sort of automatic generic competition that brought prices down so dramatically for older generations of drugs will not be possible for these newer drugs.

For instance: Raltegravir, a patented HIV drug used in the needed triple-drug cocktail by MSF in its Mumbai (India) clinic to treat patients who develop resistance to first and then second regimens, costs about 1,330 euros per patient per year .

At the same time, additional threats are now emerging in the form of ongoing free trade agreement (FTA) negotiations that could choke off the production and distribution of affordable generic medicines in developing countries. The EU in particular, is currently negotiating trade agreements with several developing countries including India, Thailand, ASEAN, Malaysia and Ukraine. This article is an attempt to highlight the harmful IP provisions being negotiated by EU bilaterally with India and Thailand.

The EU India FTA negotiations, now in their sixth year, continue to include measures that could seriously restrict production of generic medicines in India. Both European Union and India are keen to ink the deal well before elections in EU and India in 2014. The draft texts of IP chapter are not made available in public and the bilateral negotiations are being carried out under complete secrecy. However, leaked draft text of India-EU FTA available in public domain reflects presence of IP and investment provisions which would impact access to medicines and greatly restrict India’s right to use TRIPS flexibilities.

The negotiations on Thailand and EU FTA began in March this year with a very short deadline for concluding the deal in less than two years. Thailand is under extreme pressure to sign this FTA by end of 2014 as the Generalized System of Preferences (GSP) for Thailand will be withdrawn by EU January 2015 resulting in depletion of its exports to Europe. There is a strong apprehension among civil society that the EU will use this pressure to push Thailand to accept TRIPS Plus IP provisions that will further undermine access to affordable generic medicines for people in Thailand.

Proposed Intellectual Property Provisions in the EU draft text

Data exclusivity: extending monopoly status

Data exclusivity would prevent a drug regulatory authority from registering a generic medicine for as long as exclusivity lasts over the clinical trial data (usually five to ten years). In addition to bio-equivalence data that is currently required, domestic producers will additionally have to submit their own safety and efficacy data to register the generic medicines. This will oblige them to repeat clinical trials – something that takes years and involves costs that the generic companies usually cannot afford. But more importantly, the repetition of clinical trials raises serious ethical concerns.

This could be applicable not just for a new drug but also for any new formulation of an old medicine, even if itâs not patented. Big multinationals can thereby enjoy market exclusivity on a large number of medicines, charging exorbitant prices, even on drugs that do not deserve a patent or where the patent has expired.

A clear example of this comes from US, where the price of colchicine, a drug that has been used to treat gout for thousands of years, rose more than 5000 percent after data exclusivity was obtained by one company who chose to take legal action to remove competitors from the market (Kesselheim, A., Solomon, D., Incentives for Drug Development â Incentives for Drug Development â The Curious Case of Colchicine, N Engl J Med 2010; 362:2045-2047).

Public outrage at the impact EU proposal on data exclusivity would have on the worldwide availability of affordable Indian generic medicines, has contributed to the removal of this provision from the EU India FTA.

However, leaked documents from Thai negotiators seen by civil society indicate that EU is going to demand five years of data exclusivity under the trade agreement with Thailand.

Extending patent term durations

A patent term extension – also known as a supplementary protection certificate – would require a trading partner to extend a patent term beyond 20 years if there is any delay in the granting of a patent or in obtaining marketing approval for the medicine. In case of the paediatric formulations, patent protection could be extended for an additional three to five years. The extra years added to the patent are years in which the patent holder can maintain a monopoly position and continue to charge artificially high prices for the drug, free from generic competition.

A recent study in Thailand projected that if a 10 year patent extension was granted as proposed under the Thai-US FTA, over the next 20 years, the price index for medicines would increase by 32 percent; spending on medicines would increase from baseline to approximately US$11.19 billion; and the domestic generic pharmaceutical industry would lose $3.37 billion.

While EU has withdrawn the text on patent term extension from the FTA negotiations with India amid public pressure, it is expected to be part of negotiation under Thai-EU FTA.

IP Enforcement

In the EU India FTA, there have been several rounds of negotiations on IP and parties are currently finalizing provisions related to intellectual property enforcement measures.

The provisions cover trade in generic medicines, as the border measures can block legitimate medicines from leaving India on their way to people in developing countries. The border measures tabled by the EU give companies the right to lodge requests with Indian customs authorities to detain, suspend the release, or destroy shipments of generic medicines on the basis of allegations of IP infringement.

Further under this provision, multinational pharmaceutical companies based on a mere allegation that their IP is being infringed upon, could claim and instigate a number of actions. Third parties – such as treatment providers like MSF - could become subject to legal action in Indian courts for simply buying or distributing generic medicines. How the Indian courts handle disputes over intellectual property rights will also be affected. The judiciary will have its hands tied and will no longer be able to balance intellectual property rights with people’s right to health.

The harsh enforcement provisions tabled by EU under India EU FTA are similar to the ones given in Anti-Counterfeiting Trade Agreement (ACTA) that was rejected by European parliament last year. EU is now trying to bring in ACTA provisions through the backdoor through the FTA negotiations.

The same provisions are likely to be included in the IP chapter of the EU Thailand FTA.

Investment measures

The draft investment chapter that the EU is now proposing in FTA negotiations poses a direct threat to health-related regulation in India. The investment provisions would expand multinational companies’ ability to sue the Indian government when it regulates health in the public interest. Investor-to-state dispute mechanisms hidden in the investment chapter can be effectively used to sue governments outside of domestic courts, with large sums of damages being claimed in investor-friendly arbitration forums (such as the ICC, ICSID, UNCITRAL)[2] to generate rulings that favour the claims of multinational companies over the government’s right and need to regulate public health.

A pharmaceutical company could use this provision to sue the government if it decide to override a medicine patent, control /regulate the prices of a patented medicine or take any other action designed to boost access to more affordable generic versions of a patented medicine. Several disputes have already been filed by corporations against developing country governments, in order to force a reversal of governmental public health policies and judicial decisions on patentability.

In 2012, US pharmaceutical company Eli Lilly & Co. started proceedings against the government of Canada through the NAFTA investor-to-state dispute mechanism (Chapter 11). It claimed that the decisions of a Canadian court to invalidate its patent on the medicine atomoxetine, violated Canada’s obligations under NAFTA and the WTO. The company is seeking $100 million in compensation.

The intellectual property rules agreed at the WTO also lay down what countries can do when patented life-saving medicines are priced out of reach for governments and therefore the vast majority of patients. This process is called issuing a compulsory licence (CL), which allows manufacturers other than the patent holder to produce generic versions of the patented medicines in question. Thailand and more recently India have issued such CLs.

Pharmaceutical companies have previously demonstrated their willingness to threaten governments for issuing CLs on the grounds of “expropriation of IP.” For instance, in 2007, when the Brazilian government issued a compulsory license for an HIV drug efavirenz, the originator company Merck issued a press release expressing “profound disappointment” and calling this an “expropriation of intellectual property “.

Globally, more and more foreign investors are challenging domestic government policy measures, including changes to domestic regulatory frameworks. UNCTAD has revealed that 62 new cases were initiated in 2012, confirming that foreign investors are increasingly resorting to investor-state arbitration to solve disputes .

Investment provisions that continue to hold governments to ransom over health and other public interest regulations, and in particular the investor-to-state dispute mechanism have drawn sharp criticism and increasing calls for a global rethink and reform. As a result, many countries including South Africa, Brazil and Australia have announced their intention to exclude investor-to-state dispute mechanisms from future international trade deals.

EU is going to push both India and Thailand to accept such harmful investment provisions in its bilateral trade negotiations.

Free Trade Agreements: Is it really a win-win situation for all?

Several studies have been done to assess the impact of TRIPS plus provisions in free trade agreements on access to medicines. All of them point to the negative consequences of such provisions on availability and affordability of essential medicines.

For example, a study forecasting the impact of the EU-ANDEAN FTA on access to medicines in Colombia showed medicine prices would increase by 46 percent and health spending would increase by up to US$1 billion annually. As a result, five million Colombians would lose access to medicines and 12,000 people living with HIV would see their life expectancy drop between 5.3 and 9.9 years.

Such trade deals only add another layer of protection to existing patent rights, which already impede access to medicines for people. Public health advocates have long emphasised the negative impacts that can emerge from FTAs and how they can damage a countryâs ability to produce, import, register and procure affordable generic drugs.

Both India and Thailand have played a huge role in providing quality, affordable, lifesaving medicines in their respective countries. Public health safeguards in Indian patent laws and policies have made affordable drugs available not just in the country but to the other developing countries. Negotiators in the EU-India FTA should ensure that all harmful IP and investment provisions that impact Indiaâs role as a key supplier of affordable medicines, are removed before signing of this agreement in the coming months.

Thailand ensured access by first setting up public sector manufacturing facilities in the late 1990s to meet the needs of its public health program and then issuing a series of compulsory licenses for the procurement of affordable versions of lifesaving drugs used in the treatment of HIV and cardiovascular diseases. Signing the trade deal with EU having TRIPS plus measures will result in escalated cost of medicines and will put the countryâs public health e program at risk of collapse.

The EU claims that it respects international agreements which balance IP protection and access to affordable medicines such as the Doha Declaration on TRIPS and Public Health. However, European Commission (EC)- the negotiating wing of the EU on international trade deals- seems to be going in completely opposite direction. EC Trade Commissioner Karel de Gucht and his team continually place pressure on developing countries like India and Thailand to accept IP provisions more stringent than internationally-agreed standards.

Aggressive IP proposals will in the long run undermine the constitutional right to life; dismantle public health safeguards enshrined in national laws, and significantly reduce the local capacity to produce price-lowering generic medicines. Yet FTAs attract little public attention, as they are negotiated in secret, despite repeated requests from public interest groups to open them to public debate and parliamentary scrutiny.

The Government of India and Thailand should ensure that such FTA negotiations that affect public health must be conducted with adequate levels of transparency and public scrutiny, and access to the negotiating texts must be increased. They should also remain firm in their resistance to such proposals in negotiating FTAs, and ensure that public interest does not get overshadowed by commercial interest as failure to do so will cut have dire consequences for access to medicines for millions.

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Notes:

[1]United Nations Childrenâs Fund (UNICEF), United Nations Population Fund (UNFPA), the Presidents Emergency Plan for AIDS Relief (PEPFAR), and the International Dispensary Association (IDA)- world’s largest non-profit supplier of high-quality, low-cost generic drugs and medical supplies.

[2] International Criminal Court (ICC), International Centre for Settlement of International Disputes (ICSID), United Nation Commission on International Trade Law (UNCITRAL)

News Link n. 50

The news links are part of the research project GESPAM (Geopolitica, Salute Pubblica e Accesso alle Medicine/Geopolitics, Public Health and Access to Medicines), which aims to focus on the best options for the use of trade and government rules related to public health by resource-limited countries.

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Global Health and Idealism in the Age of "Voluntourism": Matching a Workforce’s Intention with Outcomes

In its present form, short-term medical trips represent a sub-optimally deployed resource. They could, however, address global health needs and issues, if we let them and if we facilitate them to do so in a socially conscious, appropriate way

Global Health and Idealism in the Age of “Voluntourism”: Matching a Workforce’s Intentions with Outcomes

by Lawrence Loh*

Adjunct lecturer at the University of Toronto’s School of Public Health, co-founder and Chief Medical Officer for The 53rd Week

In an era of social media dominated by Twitter and Facebook, it comes as no surprise that young health professionals worldwide are more aware than ever of global health issues facing our societies collectively. The idealism of youth foments individual desires to address poverty and inequality, reduce disease and disability, all while fostering wider transnational, intercultural understanding. At the same time, modern transport and communication links make it easier for them to identify opportunities and travel abroad, effectively allowing them to turn dreams into reality.

These young health professionals are deeply concerned with critical global health issues, often volunteering on a wide range of charitable activities at home and abroad. Research topics focus on various global issues, and advocacy takes place both through traditional routes as well as an ever-growing number of issue-based societies. Volunteers travel the world, providing service and skills with organizations big and small. Constantly interconnected by the web, today’s young leaders produce homemade videos to raise awareness, source donations through crowd-funding online, and lobby their leaders through the flattened world of e-mail and social media.

The impact of such efforts matches their heterogeneity, with initiatives ranging from large and readily apparent changes to potentially harmful outcomes for stakeholders. One only needs to look at the speed by which internet “memes” spread to understand how quickly information can be disseminated if the right vehicle is used. Many organizations and campaigns have successfully used the reproducibility and transferability of social media today to raise awareness of critical global health issues. At the same time, other well-meaning efforts driven by young professionals have far more questionable benefits and potential harms.

Increasing popular media coverage has focused on the impact of volunteering abroad, often called “voluntourism”, and the sometimes negative effects such well-intentioned efforts have on the receiving communities. Interested visiting volunteers from the developed world clearly gain much from these experiences, and often go with the very best of intentions. Despite this, there is growing sentiment that improperly conducted efforts come across as self-serving, given the ethical and sociocultural considerations involved, the unequal relationship between visitor and host community, and the significant draw on local resources to the resultant minimal impact of such efforts.

This growing sentiment, together with popular media anecdotes of the harms of “voluntourism”, often are simple analyses that have yet to account for a number of key considerations. Firstly, there exists a real need for skilled human resources to address critical global health issues in the developing world, which already suffers from shortages due to the outmigration of skilled workers. Secondly, global health problems continue to grow unabated in quantity and quality, and interest in addressing these problems comes from both governments and young professionals. Finally, such efforts represent huge collective investments -both in terms of finances, manpower, and intellectual effort- from volunteers, sending organisations, and local partners. It is an investment that is currently not being optimally realised.

Taking this classic puzzle in business terms, there is a clear need, a defined interest, investment and product, and suboptimal returns and outcomes. What is the market outlook? What is the context in which these operations currently occur? And finally, what are some strategies we can use to ensure these investments produce the primary and secondary outcomes we are looking for, and what are those desired outcomes?

Market outlook: need, interest, and barriers

Global health is everywhere in today’s world. Definitions abound about what constitutes a global health issue, but simply put, Koplan’s definition stands as the most simple: global health is about the issue, not where the issue is located; any health issue with transnational implications is “global” by nature. Some examples include the emerging infectious disease threats, growing non-communicable disease, climate change, the epidemic of injury, and the scourge of extreme poverty and malnutrition alongside a contemporary nadir of mental health. For young health care professionals, the need is real, and they feel a desire and capability to address challenges in the context of their diverse interests and skill sets.

Global health is valued. Experience abroad is look at favourably on resumes, institutions with global health programmes are more heavily sought after by top students, and whole local economies in the developing world rely on foreign aid and visiting team contributions to their programs. A 2011 survey of medical students in the United States found that 65% of respondents expected to participate in a global health opportunity abroad. These volunteers participate for myriad reasons; while all often intend to “do good” or “make a difference”, they often harbour personal growth goals as well.

Global health work occurs in a modern world where jet travel makes it possible to be anywhere within 36 hours; a world where a single mobile phone provides more knowledge than has ever been historically available to an ordinary citizen. At the same time, that modern world constrains the finances and times of young professionals through extensive training requirements, complex daily schedules, and limited holiday time. Short-term volunteer opportunities thus become the only viable outlet for interested young professionals looking to develop a global health interest.

The market outlook thus suggests that interest and participation in short-term global health work will continue to grow, given the continuing population health challenges coupled with expanding interest and access to various opportunities.

Context: harms, benefits, and values

Various stakeholders dictate the terms of short-term medical volunteerism’s present context. Traditional global health agencies, such as Doctors without Borders (MSF), have often attracted many global health volunteers previously. However, their extensive time and training requirements limit the ability of many young professionals to commit to their work abroad. The concept that “long term work” is the only way to do global health abroad is a holdover from a previous era, where those who wanted to “make a difference” abroad often packed up the van, moved away from the industrialised world to a less developed country for decades, and crafted a career and commitment that way.

Short-term volunteerism abroad, of which medical work is one small part, is a disruptive change that has particularly arisen in North America (but also in Australia, New Zealand, and Western Europe) since the late 1990s. Consider the proliferation of “alternative spring breaks” or “service trips” that have popped up from institutions ranging from major universities to small-sized non-governmental organisations (NGOs) and churches/community centres. A simple Google search for “medical missions” or “short-term medical trip” comes up with tens of thousands of results. These trips represent enormous numbers of volunteers being sent abroad. Leaving aside the obvious variability (particularly in their impact and ethics), the assessment of benefits and harms from these trips is critical.

Young healthcare professionals clearly benefit from going abroad. Research has documented the obvious benefits - exposure to disease entities and presentations not available at home, increased clinical acumen which feeds decreased reliance on diagnostic testing, and the development of professional networks and relationships both with the community abroad and with other members of the team they join. They also develop an awareness of global health issues and the need that is out there and are better placed to act as advocates, having experienced it first-hand.

The proliferation also reflects the benefits for sending organisations. For medical schools, many faculty and medical student candidates are looking for international connections to pursue research or advocacy work. Running short-term educational experiences abroad allows these institutions to attract top candidates, gain stature, and win funding for these efforts.

The picture is less clear for the receiving communities abroad. Many short-term volunteer efforts focus on manual labour (e.g. painting schools or building houses) or downstream interventions (e.g. clinical care or surgery.) More upstream interventions that address the underlying determinants of health are less often addressed, as the length of time these trips occur within precludes a deeper examination of the issues. Together with this limited benefit, the communities experience numerous harms; they often commit limited resources to hosting such trips, and while they are developing relationships with professionals from abroad, such relationships often occur within an unequal power dynamic. More challenging is the nature of the benefits received; there is no continuity of care or follow-up to deal with complications, and the power inequality precludes the local community from dictating what their priorities might be.

The final perspective, perhaps, is to look at what short-term volunteerism offers the world. While the power dynamic is a concern, few can argue that the carrying out of these relationships does build some form of a relationship which helps to flatten the world and build bridges between communities. Such efforts provide a vehicle to increase understanding between disparate peoples and reaffirms societal values of charity and altruism. The data that arises from these trips can also be used to support research and biosecurity efforts. The harms from a world perspective include the potential expense of resources and the carbon footprint, and the ongoing perpetuation of a colonial mentality (related to the previously described power dynamic), but one can argue that breaking down boundaries between world communities is an opportunity that we shouldnât waste.

Considering the foregoing, there seems to be a sea change in values and beliefs related to global health work. Many young physicians who are interested in pursuing work abroad describe frustration with the old models and being able to build a career that allows them to contribute to meaningful initiatives. Long-term strategies, while still valuable, are less attractive to a generation that only has short-term time and finances to offer. At the same time, however, our societal values of altruism, volunteerism, and charity remain very much in place. It would seem the question should focus less on the value of such trips - that’s clear and evident right now. Rather, our question should be how we can take these deeply personal investments and make the more impactful, allowing them to retain current benefits while mitigating harms.

There is an opportunity here to make the short-term paradigm more effective, and to ensure that all these newly proliferating alternative spring breaks and medical mission efforts are not causing harm, but are recognised as valuable human resources making a genuine impact to mitigating global health needs.

Where to from here? Strategies and perspectives

Many traditional organisations have come out and identified problems with short-term medical volunteerism. One non-profit organisation, for example, has come out and called them the “worst practices” in global health. Discussions on the issue are widespread but have not kept up with the growth in interest. A 2008 paper by Maki and others found that over a quarter of a billion dollars and 6000 volunteer hours had been invested in published efforts alone, and this has likely only grown in the years since. While many global health stakeholders are aware of the issue, few people have begun to suggest viable solutions; short of closing off the airport and preventing people from going, what can the global health community do to optimise these experiences and their outcomes?

That same community is ever acutely aware of the challenges they face in the post-Millennium Development Goal that is only under a thousand days away. There have been calls by the World Health Organization to promote universal health coverage and by the World Bank to eliminate extreme poverty by 2030. These are not simple goals. They will require significant human resource and financial commitments by governments that are cash-strapped following an economic crisis. At the same time, concomitant threats in the rise of chronic disease, mental health, injury, and emerging communicable disease threats (particularly antimicrobial resistance) threaten to set back all the progress that has been made by the global health community in the past decades.

It’s time to stop ignoring short-term volunteer trips and dismissing them as “band-aid.” They are only band-aid if we let them be. If anything, they represent an opportunity to crowd source and harness the idealism and manpower of a young generation of physicians, nurses, pharmacists, and allied health professionals, as well as professionals from other disciplines. There needs to be greater grant support and research funding to help understand this phenomenon and how it can support global health work.

Could we take short-term trips and crowd-source them towards addressing the social determinants of health? Instead of going to a community for a week and handing out pills, could twenty or thirty coordinated short-term teams instead work on building a water sanitation system or professional development that supports the development of local capacity? If people are going to put their efforts into such means anyway, can we not figure out ways to make sure the means justify the ends?

The next generation is idealistic and wants to make a difference. It falls to us to train them and come up with paradigms that allow the appropriate, ethical harnessing of their passion and involvement. Done right, these trips could retain all the benefits of breaking down global barriers, while having the added of bonus of adding genuine global impact.

The old paradigm of packing up the van and moving to Africa for twenty years is less relevant today; short-term volunteerism is here to stay. It is in our interest to not ignore it, but rather challenge and understand it. In its present form, short-term medical trips represent a sub-optimally deployed resource. They could, however, address global health needs and issues, if we let them and if we facilitate them to do so in a socially conscious, appropriate way. Taking these steps today will ensure that a new generation of global health practitioners will be at the table, not just considering the hard questions of our time, but instead actively answering them and safeguarding the future of their children and our ever-changing world.

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*Dr. Lawrence Loh is a global public health and family physician based in Toronto. He serves as a medical specialist for the Public Health Agency of Canada and as an adjunct lecturer at the University of Toronto’s School of Public Health. A proud alumni of the Schulich School of Medicine at the University of Western Ontario, he completed his residency at the University of Toronto and obtained his Master of Public Health from the Johns Hopkins Bloomberg School of Public Health. He serves as co-founder and Chief Medical Officer for The 53rd Week and is committed to reducing the harms and maximising the outcomes of short-term global health experiences through awareness advocacy, innovation, and research.

To learn more about what The 53^rd Week is doing to improve short-term volunteerism abroad, visit www.the53rdweek.org