Service on Health Issues (Aug20/04)
Geneva, 7 Aug (D. Ravi Kanth) – Several developing countries have expressed serious concerns at the World Trade Organization about rising “vaccine nationalism” and attempts to restrict affordable access to vaccines and therapeutics for combating the Covid-19 pandemic, as the worsening health crisis has continued to ravage countries by claiming nearly 700,000 lives around the world.
At the WTO’s TRIPS Council meeting that ended on 3 August, members elected South Africa’s trade envoy Ambassador Xolelwa Mlumbi-Peter as the new chair of the TRIPS Council.
The meeting witnessed sharp discussions on “IP measures in the context of the Covid-19,” “intellectual property and the 1998 e-commerce work program,” and “intellectual property and public interest: beyond access to medicines and medical technologies towards a more holistic approach to TRIPS flexibilities”, among others, said a participant, who asked not to be quoted.
The developed countries agreed to discuss TRIPS flexibilities beyond access to medicines and associated patent-related issues, but emphasized that intellectual property rights (IPRs) must be protected and enforced while innovation must be accorded protection, the participant suggested.
On the issue of non-violation and situation complaints under the TRIPS Agreement, positions remained unchanged between the United States and Switzerland on the one side, and India and South Africa on the other.
India and South Africa among others expressed serious concerns about the debilitating impact that non-violation complaints in TRIPS can have on the regulatory policy space of members and on the TRIPS flexibilities.
“These complaints can not only have a chilling effect on Member’s exercise of their IP regimes but also severely restrain ability of Members to achieve public policy objectives,” India argued.
However, the United States, Switzerland, and the European Union stuck to their position that the moratorium on TRIPS non-violation complaints should be discontinued, the participant said.
With emerging intellectual property disputes that could hinder development and production of COVID-19 vaccines, South Africa expressed concern that “the rush by developed countries to sign deals to gain preferential access to vaccines” will leave many countries behind.
“Vaccine nationalism may address short-term political demands of a country but drastically falls short of what is required to contain this pandemic,” said a South African delegate at the TRIPS Council meeting.
“World leaders from the north and south have referred to vaccine as a global public good, that should be fairly and equitably available globally, leaving no one behind,” said South Africa, emphasizing that “now is the time to put it into action.”
South Africa pointed out that “beyond access to pharmaceuticals and biosimilars, the effects of patents have also hindered the introduction of affordable vaccines in developing countries, with the focus on pneumococcal conjugate vaccines (PCV) and human papillomavirus vaccine (HPV).”
South Africa suggested that “the patents increase uncertainty, costs and delays in competition resulting in high prices for low- and middle-income countries.”
“The challenge before us,” said South Africa, “is to produce an effective vaccine to meet the needs of the world population of 7.8 billion in as short a time frame as possible.”
It will require “the sharing of knowledge and technology of successful vaccines so that the widest distribution at lowest cost can be achieved,” South Africa argued.
In a separate development, the World Health Organization chief Dr Tedros Adhanom Ghebreyesus on 6 August warned against “vaccine nationalism”, saying that “vaccine nationalism is not good, it will not help us.”
During his interaction with the US-based Aspen Security Forum, the WHO chief argued that “for the world to recover faster, it has to recover together, because it’s a globalized world: the economies are intertwined. Part of the world or a few countries cannot be a safe haven and recover.”
On the discussion on Covid-19 at the TRIPS Council meeting, South Africa emphasized that “curbing the pandemic and limiting the social and economic fallout is dependent on an unprecedented timely rollout of sufficient quantities of medical supplies to all countries in need including masks, personal protective equipment, ventilators, diagnostic kits as well as therapeutics and vaccines as they are identified.”
It requires “global solidarity to transfer of technology and massively scale-up manufacturing globally,” South Africa suggested, arguing that “there are vast shortages of medical products within a country as well as between developed and developing countries.”
Moreover, with the possible second waves of the coronavirus, “countries must take measures to ensure that they are able to restock medical products that will be needed to fight the virus,” South Africa said.
The WHO has estimated that around 500 million tests are needed during the next 12 months in low- and middle- income countries.
“Testing, if deployed in a timely way, could contribute to saving at least 9 million lives and avert at least 1.5 billion COVID-19 infections,” South Africa argued.
There is an urgent need to develop new rapid diagnostic tests that are reliable and affordable, South Africa suggested, pointing out that “the challenge of intellectual property is most apparent in the area of therapeutics.”
Referring to several of the therapeutics that are under investigation and that do not have patents granted or pending in many countries, particularly for the drug Remdesivir, South Africa said that “earlier this month, it was reported that Gilead had agreed to supply the US its projected production for the next three months, raising concern about supply of Remdesivir to other countries.”
Commenting on Gilead Sciences that developed Remdesivir, South Africa said that “Gilead has entered into 9 licensing agreements with generic manufacturers from 3 countries for the supply to 127 countries.”
“These limited, non-transparent exclusive licenses (obtained by Gilead) seem to be an attempt to contain competition by creating an oligopoly and generic manufacturers globally that can contribute to expanding global supply have been excluded,” South Africa noted.
South Africa cautioned that “the lack of transparency, and accountability in the present dire times is extremely worrying and dangerous.”
“It is an indicator of the IP and access challenges ahead of us, that the WTO Members need to address effectively and swiftly,” South Africa argued.
In its intervention during the discussion on the Covid-19 pandemic, India said that “while the disease has no preventive vaccines at the moment, more than 100 candidate vaccines are in various stages of development” and “similarly, many medicines are being tried for treating this disease.”
“Though a safe and effective vaccine may still be a few months away, countries are already competing to lock in assured access, which may drive up the prices and crowd out others who may find it difficult to access it at affordable prices,” India warned.
India called on the WTO members to “work together in TRIPS Council to ensure that IP rights do not block access to critical technology required for rapid scaling up and augmenting the manufacturing capacity for such medicines, vaccines and other goods.”
The ACP (Africa, Caribbean, and Pacific) group has called for holding a workshop to discuss IP (intellectual property)-related challenges with respect to access and to explore approaches to deal with COVID-19 in the context of intellectual property rights.
South Africa, India, and several other countries supported the ACP group for convening the workshop at the earliest.
While the WTO should be cognizant of IP obstacles across essential medical products needed to contain the pandemic and take urgent steps to address these barriers in a comprehensive manner, the time has come for taking a fresh look at the “WTO TRIPS Agreement” which provides a number of flexibilities that may be utilized by member states to overcome IP obstacles, said South Africa.
“In anticipation of such barriers,” said South Africa, “some WTO members have undertaken urgent changes to national patent legislation to make it easier to issue compulsory licenses.”
But there are a number of challenges, South Africa said. These challenges include:
1. IP barriers go beyond patents, and often flexibilities in other intellectual property such as industrial designs, copyright and trade secrets is often less understood and implemented nationally.
2. Developing country Members may face legal, technical and institutional challenges in using TRIPS flexibilities. This is especially true for countries that have never utilized flexibilities such as compulsory licenses.
3. When an exporting country is producing under a compulsory license mainly for export, the mechanism established by the 30 August 2003 decision, and later translated into an amendment of the TRIPS Agreement as Article 31bis, would be applicable. This mechanism waives the condition in Article 31(f) that a compulsory license should be predominantly for the supply of the domestic market.
However, experience in using this mechanism is largely non-existent. In 2006, Medecins Sans Frontieres (Doctors without Borders) attempted to use the procedures to export HIV medicines from Canada to Rwanda but it concluded that the mechanism is neither expeditious nor workable. The implementation of the Article 31bis mechanism at a national level is rather limited or may not achieve its intended objectives. Further, some countries have opted out of using this system as importers, which may pose a challenge to access.
4. Several voluntary initiatives have emerged since the outbreak of COVID-19 including pledges and voluntary licenses. While these initiatives are recommendable, these are ad hoc initiatives, and simply inadequate to systematically and comprehensively address IP barriers. IP holders of essential technologies may also decide not to participate in such initiatives.
Commenting on the WHO’s COVID-19 Technology Access Pool (C-TAP) calling on IP holders to voluntarily issue global non-exclusive licenses or to voluntarily surrender intellectual property rights to facilitate the wide-scale production, distribution, sale and use of such health technologies throughout the world, South Africa said that there has been no response from any pharmaceutical company.
“Instead, limited, exclusive and often non-transparent voluntary licensing seems to be the preferred approach and these are insufficient to address the needs of the current COVID-19 pandemic,” South Africa argued.
It called for new bold measures that will comprehensively and expeditiously address the IP challenges.
South Africa called for considering the following approaches. They include:
(a) Members must explore international collaborations and binding commitments to facilitate the open sharing and right to use technologies, know-how, data and global non-exclusive rights to use and produce COVID-19 medical products.
(b) Members must take policy and legislative measures to ensure that patents and other intellectual property do not erect barriers to access to medicines, diagnostics, vaccines and medical supplies and devices. This includes addressing “evergreening” of patents by restricting the grant of secondary patents on known medicines and excluding from patentability second medical uses as being mere methods of treatment in terms of Article 27 of the TRIPS Agreement.
(c) Members are encouraged to take measures to facilitate the local manufacturing or import of essential medical supplies, devices or technologies including diagnostics, medicines and vaccines.
In short, the TRIPS Council meeting has paved the way for initiating a major discussion on TRIPS flexibilities as part of the WTO reforms, said another participant, who asked not to be quoted.