Civil Society Key In TRIPS Flexibility Implementation

[Note: This story is part of the Supported Series on The Role of Civil Society In TRIPS Flexibilities Implementation, made possible by the Make Medicines Affordable organisation. IP-Watch retains editorial independence over the articles in this series.] 

[This article has been translated into French, Spanish, Portuguese, Russian and Thai, available here.]

When the agreement on intellectual property was adopted by the World Trade Organization, a number of flexibilities were included in the text, mainly to give developing countries policy space to implement the agreement with development considerations. However, some countries through lack of awareness or economic pressure have not used those flexibilities fully, and found themselves facing difficulties addressing their public health needs, which some associate with this failure to use the flexibilities. Civil society has engaged in notable efforts to counter pressure and raise policymakers’ awareness for a wider access to medicines.

Durban International AIDS Conference in 2016 protest against Gilead’s access policy of denying access to sofosbuvir to several middle income countries. Credit: ITPC Global

Public health flexibilities in the 1994 WTO Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) include compulsory licences, parallel imports, research exceptions, and the control of anti-competitive practices.

According to presentations made at the Global Summit on Intellectual Property and Access to Medicines organised by the Make Medicines Affordable (MMA) project earlier this year, there are several causes for concern. Among them are patent examination processes which do not take into account public health considerations, and counterfeit laws and policies that feature definitions including generic medicines in the same scope as counterfeits.

Also of concern has been bilateral and other free trade agreements including clauses that limit the use of TRIPS flexibilities, referred to as TRIPS-plus clauses, going beyond the TRIPS requirements. This has even been the case in free trade agreements involving least-developed countries, which are otherwise exempt under the TRIPS agreement from the obligation to enforce IP rights on pharmaceutical products until 2033 (IPW, Health & IP, 17 January 2018).

Over the last two decades, civil society has been actively defending access to affordable to medicines, making use of TRIPS flexibilities, and lobbying policymakers.

TRIPS Flexibilities Part of a Strategy

According to Pedro Villardi, of the Working Group on Intellectual Property coordinated by the Brazilian Interdisciplinary AIDS Association (ABIA), TRIPS flexibilities should not be looked at separately, but rather like a wide spectrum of policy tools to be used strategically.

Civil society, and in particular people living with HIV or hepatitis C, have a unique perspective on the issues of access to medicines, he told Intellectual Property Watch. Civil society has learned how to use TRIPS flexibilities and to interpret TRIPS articles, he said, adding that one of the most important factors to ease access to medicines is to establish stricter patentability criteria.

In order to push policymakers into action, civil society uses a wide range of political tools, according to Villardi, including dialogues with high level stakeholders, such as ministers of health and ministers of trade, as well as policy dialogues with patent examiners.

Civil Society Action Leads to Price Drop, USD Millions in Savings

According to I-MAK, the organisation started working to increase access to HIV treatment in India in 2006. Its legal work and research has now expanded to 49 countries and 20 treatments for 8 diseases. According to I-MAK, its efforts has helped government health programmes save over US$1billion in the past 12 years.

I-MAK successful patent challenges on four HIV drugs in India led to a 51-89 percent price drop compared to the originator prices, it said.

According to an MMA post, an action from the Fundación Grupo Efecto Positivo (FGEP), which led pre-grant patent oppositions on two drugs: TDF/FTC/EFV (Atripla) and TDF+FTC (Truvada) and conducted meetings with policymakers and suppliers, resulted in the procurement of generic versions of these drugs from the manufacturer Cipla and a local generic producer. The price reductions of 68 percent on Truvada and 95 percent on Atripla are generating annual savings of US$50.8 million in Argentina, MMA said.

Watch Dog, Pressure and Educational Functions

For Othoman Mellouk of the International Treatment Preparedness Coalition, civil society has held a critical role in raising awareness about issues with the TRIPS agreement and the importance of flexibilities.

Each time TRIPS flexibilities have been used, be it compulsory licences or patent opposition, civil society has been critical to push government, to create pressure, and to counter-balance the EU or the US pressure, he told Intellectual Property Watch.

In the early years, he said, leading generic companies were filing patent opposition, but now it is mainly civil society, seeking to prevent abusive patents and defend TRIPS flexibilities.

He underlined the patentability criteria as the most important factor to avoid abusive patents, and save the trouble of going into an opposition procedure.

The fact that civil society is filing patent oppositions create pressure on intellectual property offices “to do their job properly and respect the patentability criteria,” he said.

When civil society files an opposition to a patent it comes with dialogue and it educates a lot of people about the issue, he explained.

One of the issues met in the area of access to medicines, is the fragmentation of efforts on one drug at a time and one disease at a time. Attention is being payed to “super drugs” that everybody is talking about. “We have been pushed into a system” which plays to the advantage of the pharmaceutical industry, he said, adding there is a need to really address the whole system of drug pricing.

A pivotal moment was the launch of Gilead sofosbuvir. There were issues with cancer medicines in high income countries, but it was not mediatised, he said. “There is a before, and an after sofosbuvir” which showed that IP issues do not only concern developing countries.

According to Mellouk, a growing concern is the system for validating European patents in Morocco introduced under the validation agreement between the European Patent Organisation and Morocco, which came into force on 1 March 2015. According to the European Patent Office (EPO) website, “The validation system provides European patent applicants with a simple and cost-effective way of obtaining patent protection in Morocco. At the applicant’s request, and on payment of the prescribed fee, European applications (direct or Euro-PCT) and patents can be validated in Morocco, where they will have the same effects as national applications and patents.”

“The validation procedure is not based on direct application of the EPC but is governed solely by national law,” the website explains.

According to Mellouk, patents are now easier to file in Morocco for international firms, and the grant of pharmaceutical patents has increased.

Ukraine: Inclusion in Gilead Voluntary Licence, New Patent Law

Sergey Kondratyuk, of the All-Ukrainian Network of People Living with HIV/AIDS underlined the importance of patent opposition among TRIPS flexibilities. The organisation spearheaded patent opposition in Ukraine, he told Intellectual Property Watch.

The action of the Network pushed Gilead into including Ukraine in its voluntary licence agreement in August 2017 (along with Malaysia, Thailand, and Belarus) in their sofosbuvir voluntary licence. Sofosbuvir is a treatment against hepatitis C.

The push of the Network for more stringent patentability criteria also encouraged the Ukrainian government into a patent law reform, he said (IPW, Health & IP, 30 April 2018).

On the Gilead voluntary licence agreement, although a positive step, he said, still has limitations. For example, he explained, Gilead is preventing any competition from other Indian companies than those part of the agreement, and continues to file patent applications on sofosbuvir at the Ukrainian patent office. The Network will thus continue to file oppositions to such patents, he said.

Role of Civil Society Key in Access to Medicines

According to Prof. Frederick Abbott, Edward Ball Eminent Scholar Professor of International Law at the Florida State University College of Law, the role of civil society in the implementation of TRIPS flexibilities has been key. One of the great success stories dates back to the late 1990s, when civil society groups pressed the United States government to back off the pressure placed on South Africa so the country could access more affordable HIV medicine.

The impetus for the Medicines Patent Pool (MPP) initially came from James Love, president of Knowledge Ecology International (then CPTech), taken forward by the Médecins Sans Frontières Access Campaign led by Ellen ‘t Hoen, and eventually with UNITAID funding all contributing to the launch of MPP, Abbott explained to Intellectual Property Watch.

“The MPP has been a pretty substantial success, and it is fair to say that it was the pressure from NGOs and civil society on the originator pharmaceutical industry that encouraged them to participate in the MPP and other voluntary licensing schemes,” he said.

Another development that rose out of NGO movement traces back to the early 2000s to create a mechanism for addressing insufficient research on so-called neglected diseases. That eventually led to the Drugs for Neglected Diseases initiative (DNDi), “which has been a big success story,” Abbott said.

Efforts to keep TRIPS-plus measures out of trade agreements arose from practical difficulties that NGOs, governments and the public were confronting in accessing medicines. Civil society and other actors’ efforts, including those of the World Health Organization, helped to push discussions with governments on how best to amend their laws to take account of TRIPS flexibilities, including how best to implement potentially burdensome FTA rules.

Multilateral organisations are also playing a role in the implementation of TRIPS flexibilities, such as the WHO, UNDP, UNCTAD, the WTO, the World Intellectual Property Organization and the World Bank, he said.

According to Abbott, “almost everywhere government officials responsible for promoting and protecting public health are very receptive to implementation or consideration of mechanisms which will promote access while allowing innovation to occur.”

It is typically the pharmaceutical industry lobby which is pushing back, and painting a “misleading picture” that relies on arguments unrelated to the pharmaceutical sector, such as that implementing flexibilities that promote access to healthcare (and that reduce employee healthcare expenses) might generally shine a negative light on the country for foreign direct investment, he said. “Corporate executives outside the pharmaceutical sector are not so short-sighted. They recognize the importance of containing healthcare costs,” he said.

A major problem with those misleading arguments is that they are conveyed up to the presidential level of the country, said Abbott, and since most governments work with a lot of authority flowing down from the presidential office that affects the outcome of trade negotiations and legislative efforts.

Image Credits: Othoman Mellouk – ITPC Global