The year of 2015 marked the 20th anniversary of the Agreement on Trade-Related Intellectual Property Rights (TRIPS) under the auspices of the World Trade Organisation (WTO). TRIPS came into being and faced controversies since its early years. The impact of TRIPS on access to medicines and innovation has triggered international activism and resistance, especially from developing countries. Essentially, medicines that were once excluded from patent protection in many countries are now subject to patenting as required by TRIPS.
Following the HIV/AIDS epidemics in Sub-Saharan areas during the 1980-90s, the patent monopoly and high prices of newly marketed HIV/AIDS medicines made the treatment out of reach for many. This public health crisis pushed the only normative development under the Doha negotiation of the WTO leading to the adaptation of the Doha Declaration of TRIPS and Public Health in 2002, and consequently the protocol amendment of TRIPS itself in affirming certain flexibilities in balancing the public health needs of its members. Some argue that the current mechanism of TRIPS, which contains a number of flexibilities on patenting, is good enough for members to use according to their needs, and others disagree, arguing that global political economy and patenting practices have presented a rather more complex picture concerning the debates on intellectual property, access to medicines and innovation.
The first question one might consider asking is the extent to which patent could be used on medicines, and why it matters. While TRIPS only sets the minimum and general standards, countries can decide the specific criteria in judging whether something deserves a patent. The current practices tell us that nearly every step of development and manufacture of a chemical pharmaceutical product could potentially be subject to patent protection. Variations exist among different countries depending on national patent law specifics, but the industry will pursue patents by submitting applications on the chemical compound, derivative forms such as selective salt, polymorphs, ester, crystalline forms, pro-drugs, process of making the compounds, formulations, different dosages forms, and the intermediate chemicals, and so on. Many such applications are not approved in countries where those are considered merely as small changes on the known medicines, and not really a technical breakthrough. And yet, as long as those small changes are granted patent in some countries, the industry gets prolonged monopoly in those markets for another 20 years and beyond. This is the so-called ‘ever-greening’ strategy that is functioning as an unwritten norm in practice.
For the debates over access to medicines and innovation, the ‘ever-greening’ practice plays a vitally important role. On one hand, it delays the forming of generic competition medicines that is critical in improving affordability of medicines in the market. On another hand, more fundamentally, it constructed a misleading message of how patent systems treats inventions. While small and obvious practices in the laboratories can easily find their ways to legal recognition and thus form a commercial monopoly, the very understanding of what is innovation gets further blurred. The question of whether the objective of scientific research for innovative outcome is to get more patents as the indicator, or to aim for continuously making progress by quickly publishing the results for public and peers scrutiny, has become indecisive. The possible scope of patenting, with clearly commercial motivations, keeps intruding into every corner of innovation practices.
The technical side of the question as previously mentioned is closely linked to the broader policy debate in the context of global trade and public health. First of all, if talking about the global governance structure of intellectual property in relation to public health, a more nuanced picture has been presented to us in addition to looking at TRIPS alone. While TRIPS deals with rules and principles of intellectual property law specifically in the context of trade liberalisation, the substantive rules and principles have also reflected the old 19th century Paris convention concerning industrial property that is now administrated by the World Intellectual Property Organisation (WIPO). The political relevance of WIPO’s normative discussion has been eventually consummated with those of the WTO. At the same time, the increasing trend of creating new legal obligations on intellectual property through bilateral negotiations on Free Trade Agreement (FTA) and Investment Treaties have gradually overtaken the WTO’s central role in the debates over patent and access to medicines and innovation. While the WTO and WIPO are products of multilateralism of a kind and subject to some levels of sovereign and public scrutiny, the bilateral and regional FTA processes on another hand are carried on with no clear global governance structure above them.
This insufficient global governance structure has led to a failure to oversee the expansion of intellectual property, and this has in turn made the mitigation of its negative impact on public policy more difficult to pursue. It on another hand gives sufficient rooms for FTAs to raise the requirements that are not covered by the WTO and WIPO laws, such as those concerning patent on medicines. Examples of this kind could be found in a number of FTAs negotiated between developed and developing nations where provisions such as prolonging patent terms, stricter data exclusivity protection than what TRIPS asks, and making it difficult for countries to use compulsory license, etc. have been commented on and studied intensively, and these studies have demonstrated a significant detrimental impact on access to medicines and innovation capacity building for a country in the long term. For countries who continue to suffer from increasing prices of essential medicines that are necessary in order to operate the public health system, and for countries who have the aspiration of developing more innovation-capacity so they are able to catch up, the trend of unlimited expansion of intellectual property that only benefits a small group of companies in the global context has created an ever-growing barrier to overcome. The very recent examples of such tension could be found from debates over the negotiations of the Trans-Pacific Partnership Agreement (TPP) led by the United States, and the Trans-Atlantic Trade and Investment Partnership Agreement (TTIP) between US and EU when both sides of the debate have had intellectual property and its contentious relation with public interests as one of the critical sticking points.
The unclear global governance structure as above mentioned has also demonstrated the importance of looking at global health challenges to access to medicines and innovation in a more holistic way in the face of the indifferential expansion of patent norms on medicines. Since the 1990s, the debates have mainly focused on the public health crisis facing developing countries. For instance, the report of ‘Public Health, Innovation and Intellectual Property’ published by the World Health Organisation (WHO) in 2002 has rightly captured the root causes behind the lack of access to existing medical tools and neglected research and development on new medical tools that address health problems disproportionately affecting developing countries. Instead of arguing which level of intellectual property protection would do the job as one might often find in industry-led publications, the WHO report concluded by pointing out the commercial motivation behind the contemporary drug discovery business, which is driven primarily by the weighting of whether a market exists to buy rather than whether people are dying from no tools to treat. Patent has played a central role in enabling the pharmaceutical industries to direct their investment to where the market is bigger, rather than where the most people need it.
A few examples in recent years have repeatedly rung the bell of developed countries, and yet they have been insufficiently addressed. While generic competition, by using TRIPS flexibilities, has helped the scaling up of HIV/AIDS treatment at global level, this could not occur so easily now in the case of a different epidemic, as more countries have started adapting stringent patent norms on medicines and the using of TRIPS flexibilities have been put on hold in some occasions. For instance, Hepatitis C has been considered as one of the emerging killer diseases in many low income as well as high and middle income countries, as the infection can eventually develop into critical situation with liver cancer. The old interferon based treatment is intolerant and painful, and oral treatment had been long wanted. The situation started changing when the drug company Gilead introduced its new medicine Sofosbuvir to the market in 2015, but was priced at 1000 USD per pill in the US market. The same medicine is offered at different tiers of discounted and yet still very high prices in different countries by Gilead. For instance, the UK was offered a price of £35,000 per patient per treatment for 12 weeks, or 24-weeks for about £70,000, all for one drug alone. The high price as such had delayed NICE (National Institute for Health and Care Excellence) in concluding its recommendation to include the new medicine into NHS scheme until an increased £190 million fund was put in place in covering ‘these very expensive new drugs’ (by Richard Jeavons, NHS England Director of Specialised Services). Facing the same frustration and pressure with high prices of sofosbuvir, France introduced a new tax tackling high prices of medicines, and patients in Spain have brought law suits to the Supreme Court demanding access to the new expensive sofosbuvir after the public health agency had failed to bring the drug in time to the public health system
And yet, other sides of the story have revealed that while sofosbuvir is a new treatment for Hepatitis C, its patent applications do not stand strongly in many countries. The patent on sofosbuvir has been rejected in Egypt for lacking novelty and inventiveness, one of its patents has been rejected in China for failing to fulfil technical criteria, rejected in India for the very same reasons, and is subject to more than 10 patent challenges before the European Patent Office. Technically speaking, someone else has discovered sofosbuvir earlier than Gilead, who owns sofosbuvir by virtue of acquiring the small firm who developed sofosbuvir in the first place. So there are pretty good chances for countries with stricter patent criteria to screen out sofosbuvir patent as underserving and thus allow generic competition into the market. There is also a chance for countries to use mechanisms such as compulsory license when public interests and policy prevails over the commercial interests on patents. Both possibilities exist for developed and developing countries to explore and use for the purpose of balancing private proprietary protection with public interests.
In the past decade, compulsory license for public health purposes and the stricter patent criteria on medical inventions have been used in many developing countries to address the public health needs and to strike the balance of private rights on patent, access to medicines and the real meaning of innovation. Notably, Indian patent law has made it clear that small changes on old medicines would not deserve a patent protection unless firm evidence could prove the significant therapeutic improvement it could bring. Those legal innovations and experiences of using the existing flexibilities of patent law are critical in leveraging the public policy spaces for all nations who are facing public health needs. But for the future prospect, something new needs to come.
The above example of sofosbuvir is only one tip of the iceberg. It is also only one such case of many that proves the detrimental impact from some of the restrictive intellectual property rules proposed by ongoing FTAs negotiations. In all those regards, the unregulated expansion of concentrated commercial interests through a globalising patent regime on medicines has been standing at the centre of the problem.
Recognising the very nature of this increasing symptom as a collective system failure is vitally important if we consider the possibilities of the way out. One might find it interesting and helpful, in such a context, to revisit a very basic question of why a patent system came to exist in the first place, and thinking about the extent to which the claimed public interests orientation of granting a patent, by exchanging for public disclosure and technology progress for all with granting a temporary legal monopoly, has been misused and gone too far from its origin. One might also find it inspiring to look back at those historical grand debates on whether and how a patent system is needed or should be placed in driving innovation, and found a number of similar arguments and debates from old times to the ones we are facing today. Reviewing history in the context of the present struggle would perhaps redirect our thoughts to questioning the inherent inconsistency of the current patent regime on medicines in which the tensions between public and private, the twists between enclosure and sharing, and the different claims over intellectual creations and innovation are not conciliated. It is perhaps also high time to note that at the 20th year of TRIPS with struggles get intensifying at a global level with further diversified forums of debates, to look for an alternative model of public oriented medical innovation while the lost ethical ground and connections concerning the distinctive nature of medicines as a lifesaving necessity rather than luxury commodity could be redefined.
Yuan Qiong Hu is the Legal and Policy Advisor for the Access Campaign of Médecins Sans Frontières/Doctors Without Borders and is a PhD candidate from the School of Law, School of Oriental and Africa Studies (SOAS), University of London.
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