A network of civil society organisations chose the birthplace of the World Trade Organization, Marrakesh, to hold a global summit on intellectual property and access to medicines this week. Part of the summit focused on stringent IP measures in free trade agreements in particular with the European Union, introducing patent term extension and data exclusivity periods.
The Global Summit on Intellectual Property & Access to Medicines: Pathways to Access is taking place from 15-17 January in Marrakesh, Morocco. At the same time as the agreement to establish the World Trade Organization, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) was adopted by all WTO members in 1994.
The summit was organised by the International Treatment Preparedness Coalition (ITPC), and is meant to bring together community representatives, governments, civil society, academics, experts and international agencies to look at the impact of international trade rules on public health, and highlight the role of non-governmental organisations and patients in the implementation of TRIPS flexibilities.
A number of panels were organised around the themes of the role of patent examination to prevent bad patents; making compulsory licences (CLs) routine; understanding and resisting TRIPS-plus measures; how least-developed countries can make effective use of the transition periods; local production and technology transfer; possibilities and challenges of pro-health patent law reform in developing countries; and challenging unmerited patents.
The panel on resisting TRIPS-plus measures described efforts to fight measures that go beyond the TRIPS minimum requirements.
EU Seeking TRIPS-Plus Measures in Morocco
Mohammed Said Saadi, economist and a former minister in Morocco, said since the 1980s there has been a clear regression of human rights in the context of international trade, due to neo-liberal policies. The Southern and Eastern Mediterranean region is the object of fierce competition between the United States and the European Union, both coveting the regional market, he said.
The United States scored on the pharmaceutical front, and advanced its interests through free trade agreements with Jordan and Morocco, he said.
According to Saadi, the EU is trying to impose a new trade agreement aligned with TRIPS-plus measures that Jordan and Morocco have already accepted through their free trade agreement with the US.
The ongoing Deep and Comprehensive Free Trade Area (DCFTA) discussions between the EU and Morocco are introducing TRIPS-plus measures, he said, underlining the secrecy of the negotiations.
There have been very few studies on the impact of TRIPS implementation in Morocco and in Jordan, he said, adding that he only found one impact study. Oxfam published a briefing paper [pdf] titled, “All costs, no benefits: How TRIPS-plus intellectual property rules in the US-Jordan FTAs affect access to medicines,” in 2007.
According to the study, medicines prices in Jordan have increased 20 percent since 2001, and “higher medicine prices are now threatening the financial sustainability of government public health programmes.”
Saadi said data exclusivity has delayed generic competition for 79 percent of medicines newly launched, and almost no foreign direct investment was done by drug companies into Jordan.
EU-Mercosur, TRIPS-Plus Measures, Assessment
Daniel Pinto, counsellor, Intellectual Property Division, Brazilian Ministry of Foreign Relations, talked about the ongoing Mercosur-EU trade negotiations. The current trade agreement with the EU is being negotiated with the four founding members of Mercosur (Argentina, Brazil, Paraguay, and Uruguay), according to the EU website.
Pinto underlined the reliance of Mercosur countries on exports of agricultural products, which makes the agreement with the EU very important to access the EU market. Mercosur, however, is not as consolidated as the EU, the four countries do not have the same interests, legal systems are not always harmonised, and they also do not have much experience in joint negotiations, he said. Thus negotiations go into two tracks, the first is negotiating with the EU, and the other is building confidence among Mercosur countries, he added.
In the Mercosur discussions, Pinto noted that the EU requested that in case of administrative delay by drug regulatory authorities to bring a patented medicine on the market, the patent term would be extended accordingly. He said in that case an administrative solution should be found to address the issue, not extending the patent term, as the two issues are unrelated.
The EU follows its argument according to which over 42 percent of the total economic activity in the EU is generated by intellectual property-intensive industries, he said. However, the impact of the proposed TRIPS-plus measures on countries should also be taken into consideration, he added.
He cited a 2017 Mercosur-EU Free Trade Agreement impact analysis [pdf] of TRIPS-plus measures proposed by the EU on public purchases and domestic production of HIV and hepatitis C medicines in Brazil. The study was co-authored by Gabriela Costa Chaves, Sergio Arouca, Walter Britto Gaspar of the Oswaldo Cruz Foundation (ENSP/Fiocruz), and Marcela Fogaça Vieira, consultant for the Shuttleworth Foundation.
The analysis, which was explained by the authors in an Intellectual Property Watch Inside Views article (IPW, Public Health, 1 December 2017), found that if a 5-year data exclusivity in patent term extension is agreed upon, it would translate in an additional expenditure of US$ 1.2 billion from 2015 to 2050 for HIV medicines, and for hepatitis C medicines, an additional expenditure of US$14.5 billion from 2016 to 2051, he said.
Intellectual property is not a bargaining chip, Pinto said, and added that the lack of clarity about what is at stake in IP jeopardises efforts to preserve policy space. He called for civil society to continue to raise awareness and apply political pressure, for academia and researchers to provide impact studies based on hard facts, and for negotiators to be mindful of their responsibility toward present and future generations.
Once TRIPS flexibilities are given away, the cost of recovering them is huge, he said in his presentation.
Fogaça Vieira said the IP chapter of the EU-Mercosur FTA would affect parallel imports, provide an extension of the patent term, and introduce data exclusivity.
The impact of TRIPS-plus measures in Brazil would affect hepatitis C medicines more than they would antiretrovirals, because Brazil has put in place some policies to reduce the impact of TRIPS-plus measures on those medicines, which is not the case for hepatitis C, she explained.
She suggested that more impact studies be done on public health and human rights impacts of TRIPS-plus measures proposed in FTAs, and that the negotiations should be more transparent.
Lorena di Giano of Fundación Grupo Efecto Positivo (FGEP) in Argentina, a Mercosur country, said Argentina has no data exclusivity provision in its law. The country conducted a IP impact assessment study performed on 17 antiretroviral drugs procured by the National Ministry of Health, from 2020 to 2050, she said.
Several scenarios were explored, including some with patent extensions and data exclusivity, and a combination of those two TRIPS-plus measures, and the study showed a significant increase in public procurement budget if those measures were adopted.
Ukraine’s TRIPS-Plus Provisions
Oksana Kashyntseva of the National Institute of Intellectual Property of Ukraine said the trade agreement (Deep and Comprehensive Free Trade Agreement) between Ukraine and the EU has been costly.
In 2008, Ukraine signed TRIPS on the basis of TRIPS-plus provisions, she said, and until now, there has been no political will to implement TRIPS flexibilities into the national legislation. She described the Ukraine efforts on access to medicines, in particular the challenge of harmonising IP law, unfair competition law, and rights to access to medicines. Ukraine is working on an ongoing patent law reform.
Sergey Kondratyuk of the All-Ukrainian Network of People Living with HIV explained the court claim brought by Gilead against Europharma International, the Ukrainian Drug Regulation Authority and the Ministry of Health. The Gilead claim was based on data exclusivity protection.
In January, a settlement agreement was reached through which Ukraine had to cancel the marketing authorisation of granteziano (a generic version of original Gilead sofosbuvir), and protect Gilead’s rights. Gilead on its part had to set the price of sofosbuvir at US$250 for the government at least during the period of data exclusivity, and at US$349.90 for pharmacies, Kondratyuk said.
In December, Europharma won the lawsuit in first instance on restoring the generic sofosbuvir marketing authorisation, and Gilead served the Antitrust Committee of Ukraine with an application in investigation of concerted actions, he said.
Mohammed El Said, reader in International Trade and Intellectual Property Law at Lancashire Law School, at the University of Central Lancashire, United Kingdom, said there has been a lack of “real” innovation over decades in pharmaceutical products in terms of research and development. There has been however a rise in the number of granted patents, he said. Those patents do not have major value and contribution, he said.
Delinkage as Way Forward
In the audience, James Love of Knowledge Ecology International said the regulation of monopolies alone does not yield very strong results in terms of access to medicines. The issue of the costs involved in research and development should be addressed through delinkage of those costs from the end price of the medicines, he said. A growing number of people are focusing on the idea of separating the incentive from the price of drugs, Love said. High prices should not be a mechanism or an incentive for research and development, he said, adding that innovation should not be pitted against access.