Treating People Right Means Taking the IP Yoke Off Our Back: A 10 Point Plan to Ensure Access to new and IMproved AIDS Medicines

“Treating people right” means many things, but one of the things it means is that people living with and at risk of HIV/AIDS must have immediate and affordable access to new medicines, diagnostics, and other medical technologies to ensure that their rights to health, to reduced risks of transmission to and from others, and to beneficial treatment are maximized. In a world that treats people right, medical research would be targeted to real needs (increased potency, durability, tolerability, stability, and ease-of-use), important medicines would be quickly brought to market, quality and safety standards would be safeguarded, and the medicines would be made available affordably to all in need by maximizing robust generic competition. AIDS activists have fought the IP and Pharma monopoly system for over two decades. We’ve been most successful in driving down costs for older antiretroviral medicines in some of the poorest and hardest hit regions, but IP barriers are getting worse, not better, and limited access to the latest and future generations of life-saving medicines could mean treating people wrong.

The TRIPS and TRIPS-plus intellectual property system engineered by Big Pharma and their captive rich country trade negotiators presents grave threats to access to newer and improved medicines and diagnostics needed to treat and prevent HIV/AIDS and the many other health conditions afflicting poor people in low- and middle-income countries. That same IP system, oriented solely towards maximizing monopoly profits for patent and data originators, fails to produce many of the therapeutically targeted innovations and product improvements that would best serve the needs of the Global South. To counteract the strangle-hold of Big Pharma over the funding for R&D and its unilateral right to charge exorbitant prices affordable only to the rich, people living with HIV/AIDS and their supporters need to campaign for a multi-prong, multi-dimensional, and complementary set of strategies to ensure access to essential ARVs, including improved first-, second-, and third-line regimens. Without pretending to present a comprehensive analysis, we need a ten-point plan.

1. The most radical, immediately practicable proposal for intellectual property reform now comes from the Commission on HIV and the Law, which has just proposed a moratorium on TRIPS with respect to pharmaceuticals, a major UN study on IP, incentives, and access, retraction of TRIPS-plus demands/pressures by rich countries, and enactment, preservation, and utilization of all available IP flexibilities by low- and middle-income countries. This proposal is complemented by decade-long efforts within the WHO and elsewhere to explore alternatives for delinking the market for innovation from the market for the manufacture and sale of good quality, low-cost generic medicines.

2. Although major pharmaceutical companies have granted some flexibility with respect to AIDS medicines in terms of pricing and voluntary licensing for least developed, low-income, and sub-Saharan African countries, the middle-income countries of Latin America, North Africa, Asia, and Eastern Europe are subject to dramatically higher prices even though they (especially Brazil and Thailand) make the market for second- and third-line medicines. Big Pharma looks to big, so-called middle-income Pharmemerging Countries as its major profit center in the future. Big Pharma wants to gain hegemonic control over those markets and its access to elite and middle-class consumers, even if that means that governments might not be able to afford medicines for the disproportionate number of poor people who live in those countries.

3. The Medicines Patent Pool license with Gilead represents the widest-scope and most transparent “voluntary” license to date, but even it is highly flawed in terms of middle-income country access, limitations on API suppliers, and designator of Indian generics as sole suppliers. Importantly, however, the MPP/Gilead license preserves countries’ and generic licensees’ use of TRIPS flexibilities, including compulsory licenses, and further allows unbundling of licenses on particular products like tenofovir, which is widely unpatented in both low- and middle-income countries.

4. The recently proposed HIV Medicines Alliance, spearheaded by MPP boycotters, Merck and Johnson & Johnson/Jenssen, promises little in the way of binding commitments to open, collaborative research on pipeline ARVs and is highly restricted in terms of geographical access (least-developed, low-income, and sub-Saharan African countries). It bears a close resemblance to the WIPO Re:Search initiative, originally spearheaded by GSK for neglected tropical diseases, which also limits its geographical scope to least developed countries.

5. The exclusion of middle-income countries from robust competitive access to AIDS and other medicines can be partially addressed through concerted advocacy with respect to voluntary activities, but frankly a better alternative is broader and more coordinated use of compulsory licenses, both threatened and imposed. Positive developments beyond the 2006-2007 licenses by Thailand and Brazil include the issuance of a CL in India on a highly over-priced Bayer cancer medicine, compulsory licensing reform in China, and a concerted global campaign of patent oppositions and compulsory licenses with respect to Abbott’s lopinavir/ritonavir. Because middle-income countries face so much pressure from bullying US and EU trade negotiators and other government officials, AIDS activists will have to continue to take the lead to organize successful campaign to prod their governments into action. Although the need for IP/compulsory license activism is clearest in middle-income countries, it is also outrageous that 18 years after the adoption of the TRIPS Agreement and nearly 11 years since the historic Doha Declaration on the TRIPS Agreement and Public Health, low- and middle-income countries have not amended their laws to take maximum advantage of TRIPS-compliant flexibilities in order to adopt easy-to-use mechanisms for accessing more affordable medicines. In addition to adopting flexibilities, countries must use them. Activists in S. Africa are pushing for patent law reform, activists in East Africa are doing the same, but much stronger national and regional law reform campaigns are needed.

6. The 2003 Aug. 30, Paragraph 6 System, allegedly adopted to meet the needs of countries that lack insufficient capacity to manufacture a needed medicine locally and therefore need to import that medicine from a producer country is woefully inadequate. Because Article 31(F) of the TRIPS Agreement requires that the majority of medicines produced under a compulsory license be dedicated to domestic use, an export-import solution is needed, but the Paragraph 6 System is poorly designed and hard to operationalize and has result in only one license thus far. Regrettably, the proposed amendment Art. 31bis would codify this deficient export/import mechanism and its adoption should be opposed. Countries should instead push for easier-to-use export/import system, preferably pursuant to an Art. 30 limited exception.

7. In order to ensure access to medicines in the future and perhaps to unleash their potential as local and regional producers of generic versions of medicines patented elsewhere, least developed countries need an extension at the WTO of both the 2013 general TRIPS transition, including a termination of the counter-productive stay-put provision that locks them into IPRs improvidently legislated prior to 2005, and more especially to the 2016 pharmaceutical waiver. AIDS activists need to work proactively with developing country governments to ensure that these WTO reforms are taken forward.

8. Additional attention is needed to address innovation needs in terms of drug optimization, formulation, and ARV pipeline. At present, incentives for R&D largely cabined within the intellectual property regime that prioritizes research towards the chronic diseases of rich and middle-income consumers. There are insufficient incentives for preventative medicines, vaccines, antibiotics, neglected diseases, and curative medicines more broadly. Once an ARV blockbuster is brought to the market, there are few incentives to continue research on optimizing dosages, simplifying chemical manufacturing processes, and working on pediatric, heat-stable, and co-formulated version, let alone entirely new long-lasting delivery mechanisms appropriate for resource-poor settings. At present, there are simply insufficient push and pull incentives in the IP-based system to produce the therapeutically important products that people living with HIV/AIDS need. Moreover, the incentives that exist result in the current flawed system, where research costs are recouped by high prices on medicines even though the medicines are quite cheap to produce. Put simply, we need to explore mechanisms for funding R&D that delink the market for innovation from the market for low-cost production and sale.

9. IP barriers are immense and as discussed below growing, but we also need to overcome registration-related barriers. Inefficient, corrupt, and uncoordinated drug regulatory standards and procedures in the 200-plus countries where PWAs live deter widespread medicine registration and marketing both by Big Pharma and even more so generic competitors. Unnecessary and costly drug regulatory systems are now one of the biggest challenges to ensuring the actual market availability of the new, improved, and cheaper medicines we so desperately need. Harmonized and regional systems for granting marketing approval, fast-track registration for medicines that have been vetted and approved by the WHO Prequalification Programme and/or stringent regulatory authorities, and increased investments and expanded capacity for pharmacovigilance concerning product quality and safety throughout the supply chain are desperately needed. Under no circumstances should IP-related data exclusivity and drug registration/patent linkage provisions stand in the way of efficient mechanisms for registering generics based on simple evidence of bioequivalence.

10. Unfortunately, at the same time that activists, advocates, and pro-public health policy makers at this Conference are pushing for the access reforms summarized above, US and EU trade negotiators, working on behalf of their Big Pharma puppeteers, are pushing to increase intellectual property protections in key areas of the world. The negotiation which most immediately impacts access to AIDS medicines is the EU-India Free Trade Agreement negotiation where the EU has temporary dropped some of its demands for stronger and longer patent and data monopolies, but persists on strengthening IP enforcement and investor rights in a way that could interfere with the legitimate trade in lawful generics. The US, on the other hand, is pushing full bore ahead in the Trans-Pacific Partnership Agreement with the most outrageous patent and data monopoly provisions ever advanced in a bilateral or regional trade agreement. The US’s so-called 21st Century proposal strengthens, broadens, and lengthens patent monopolies on new forms, uses, and formulation/combinations of existing medicines and creates new monopoly protections with respect to the clinical data used to obtain marketing approval. The US proposal would prevent generic companies and health advocates from opposing poor quality patent applications; it would weaken standards of patentability so as to allow evergreening or re-monopolization of patents soon to expire; it would allow lengthening the 20-year term of patent monopolies in cases of regulatory delay; it would prevent price control efforts; and it would greatly enhance enforcement efforts and penalties both at the border and in criminal and civil actions. Via the newly leaked Investment Chapter proposal, drug companies would gain new rights to directly sue governments before private-sector trade lawyers for measures that adversely impacted their patent and data monopolies. Finally, US and EU negotiators continue to try to adopt so-called anti-counterfeiting treaties and laws, both at home and abroad, that treat the real problem of unsafe and poor quality medicines as an intellectual property issue instead of a public health, drug regulation and surveillance problem. All of these TRIPS-plus measures must be opposed by activists at the national, regional, and global level.

Lots of other initiatives are needed to ensure that people get treated right in terms of access to medicines. Good procurement and supply, accurate forecasting and avoidance of stockouts, training of prescribers and pharmacists, improved connection to care, treatment literacy and adherence support, destigmatization, point-of-care testing and diagnostics etc. are all needed. More clearly, additional resources are needed – roughly $8-10 billion a year – as well as a real action plan by PEPFAR and others to take advantage of the potential of universal voluntary access to treatment at all CD4 cell counts in order to reap the prevention benefits of clinically advantageous early treatment. Nonetheless, even if progress is made on all these fronts, IP barriers would stand in the way and make universal access much more costly. We can’t afford to pay more than needed to treat people right.