By Abhijit Das
A massive storm is preparing for a sentence on patents contained in the recently concluded agreement on the economy and trade in India-Uk. Many health defense groups working on access to experts in medicine and affordable development on intellectual property rights (DPI) are of the opinion that this provision in the APRA SAPE access to affordable drugs. What is this provision, what are the underlying problems, what can we say in his defense, and what could be his implications?
What does the layout say?
In article 13.6 of the APE, the parties recognized that “the preferable and optimal path to promote and guarantee access to drugs is done by voluntary mechanisms, such as voluntary licenses which may include the transfer of technology to mutually agreed conditions”. As a context of this provision, it is relevant to note that a patent holder may grant a voluntary license to any entity for the manufacture, import or sale of the patented drug. Most voluntary license agreements are enveloped in secrecy and very little information exists in the public domain concerning the terms of the agreement, duration, volume and countries which will be provided under the agreement. A concern concerning voluntary agreements is that by artificially limiting production and offer, patent holders are able to charge high prices and profiteers of the multiple health crisis.
The Agreement of the World Trade Organization (WTO) on the aspects linked to the trade in intellectual property rights, commonly known as travel agreements, allows certain flexibilities of public health policy as an alternatives to voluntary licenses. These include instruments such as compulsory licenses. If the price of a patented drug is very high, a government can issue a compulsory license to an entity to make or import its generic version. The generic drug can subsequently be made available to patients at a lower cost, often to a fraction of the price of the patented medication. The patent holder must be paid adequate instead of the granting of compulsory licenses.
On the surface, the controversial arrangement in the AECA may seem rather harmless. In addition, one could argue that, since India has used compulsory licenses in a single case in the past 20 years, this provision simply indicates the evidence. In addition, as very few countries have granted a compulsory license for pharmaceutical products, it could be argued that voluntary licenses are the best world practices.
Concerns about India’s exchange position
Why are health advocacy groups upset by the provision of APRA favoring voluntary licenses? This is based on history, as well as in contemporary developments. When the AIDS crisis ravaged parts of the world, in 2001, some of the largest pharmaceutical companies legally challenged the South African government attempts to invoke travel flexibilities to provide low-cost generic versions of exorbitant patented antiretroviral drugs. Attempts have also been made in other parts of the world by pharmaceutical companies producing patented drugs (“Big Pharma”) to actively dissuade developing countries from resorting to travel flexibilities, including compulsory licenses. At the WTO, in May 2000, the United States challenged a Brazilian law on compulsory licenses.
In this battle of patents on patients, the collective efforts of health defense groups and governments of developing countries led to the adoption of the DOHA declaration on the agreement of travel and public health in 2001. After days of negotiations, this declaration reaffirmed the rights of the members of the WTO to use flexibility of displacements, including compulsory license. Brazil, India and South Africa were at the forefront of this WTO fight. This has enabled many developing countries to counter the strong opposition of Big Pharma to their efforts to invoke flexibility of travel. Consequently, many developing countries, including India, have used compulsory licenses to make drugs accessible to patients at affordable prices.
Over the years, in his effort to promote his commercial interests, Big Pharma has been pressure for more strict standards on the protection of DPIs in the negotiations of free trade agreements. In parallel, any political intervention which can even have a negative impact at a distance on its profits in advance is quickly on the Big Pharma radar screen.
The controversial provision on patents and voluntary licenses in the APRA should be considered in the context of the persistent and tireless efforts of Big Pharma to prevent developing countries from using compulsory licenses. After being at the forefront of the struggle to obtain a reaffirmation of the compulsory license and other sad flexibilities in 2001, through the Inda of the APE, decisively folded in favor of a voluntary license. Consequently, health advocacy groups can, with a certain justification, of doubts about the question of whether the country will have the capacity and resolution to resist the pressure of the great pharmaceutical and to invoke compulsory licenses, even if a health crisis may require this action.
The provision of voluntary licenses in the APRA has another dimension. Until now, India has been perceived as a strong voice from developing countries on issues related to public health and access to affordable drugs. There is a serious risk that India loses its position and leadership among developing countries when these questions are discussed in various intergovernmental organizations, such as the WTO, the World Health Organization and the World Intellectual Property Organization.
In conclusion, the government must make an honesty of soul of what it has won thanks to the controversial arrangement on patents in the APRA. Although it retains legal right to use compulsory licenses, in the light of this provision, the government should be extremely resolved to resist Big Pharma’s opposition to compulsory licenses. Taking into account compulsory licenses can also expose the government to consultations and dispute settlement procedures involving the United Kingdom. The visualization of voluntary licenses as a world practices plays in the hands of Big Pharma. Instead of trying to defend this provision, the government must explore ways to minimize the damage resulting from it.
The writer is an expert in international trade.
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