An Alternative Proposal For Enhancing Developing Country Access To Patented Medicines

By Wagdy Sawahel for Intellectual Property Watch

An intellectual property model intended to preserve the structure of patent protection while adding balance for developing countries has been proposed to provide incentives for innovators to contribute toward the alleviation of suffering in developing countries in dire need of patented medicines largely owned by rich countries.

This IP model, which would increase the role of the World Health Organization (WHO) in the process, was presented recently by Amir Khoury, an intellectual property law and international trade specialist at the law faculty of Tel Aviv University. Khoury said the proposed model seeks to refine the 2005 public health amendment to the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Khoury proposal came at the 4th annual conference on technology commercialisation entitled “Technology Transfer, Research and Development (R&D) and IP Commercialisation, Policies, and Investment” in Amman, Jordan on 12-13 November.

The proposal would put greater decision-making authority on the use of compulsory licensing to obtain cheaper versions of patented medicines in the hands of the WHO. Currently that activity occurs under the World Trade Organization.

But the proposal would appear to restrict the use of such licences by governments to declared emergencies. Under the WTO, governments have greater latitude in choosing to use compulsory licences and other flexibilities to WTO rules.

Khoury said that his proposal for an enhanced “access to patented medicines” (APM) system would not stand counter to TRIPS but rather would reflect the “spirit” of that agreement, as it appears in Article 7:

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Khoury pointed out that the TRIPS agreement recognises the rights of member states to take measures that are necessary to protect their interests, especially with respect to “public health and nutrition.” Article 8 of the TRIPS agreement declares that:

[m]embers may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this agreement.

Appropriate measures, provided that they are consistent with the provisions of this agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

Khoury said that TRIPS Articles 7 and 8 have remained dormant within the periphery of TRIPS and the entire conventional international patent regime with no real effect on shaping the international IP policy. “Nevertheless, the normative weight of these articles remains relevant, and they can still be used to justify any future reformulation of the [patent regime] in the context of APM,” Khoury said.

Proposed PART VIII to TRIPS Agreement

Khoury told Intellectual Property Watch that the proposal calls for establishing clear exceptions in which countries would be entitled to produce medicines even in absence of compulsory licences either at the national level or through a proxy state. He said the authority to produce medicines would be contingent upon a determination by the WHO of the existence of national medical emergency which would be limited in time and subject to periodical review. The proposal also contains rules for extending or truncating granted compulsory licences.

International IP Community

Morad Ahmed Morad, a professor of medicine at Tanta University in Egypt, said the model “provides a fair system to tackle the problem of access to medicines for developing countries.” Morad called upon the WTO and WHO to open discussion about such a system with the view to seek ways to implement it on the ground.

However, Prabuddha Ganguli, chief executive officer of India-based VISION-IPR and a consultant to the World Intellectual Property Organization on IP capacity-building programmes in developing countries, told Intellectual Property Watch that “The approach is theoretical and does not provide any insight into the specific manner in which the issues are to be tackled.”

Richard Gold, professor of intellectual property and president of the Innovation Partnership, told Intellectual Property Watch that the world has too long been divided by opposing theories concerning the role of IP in advancing R&D on the one hand, and in preventing access to needed medicines on the other, a debate that has delayed the finding of practical solutions to the issue of access to medicines.

Gold added that “While, the Doha Agreement [on TRIPS and Public Health, which reinforced nations’ right to flexibilities in applying TRIPS] was a step forward, I agree with Khoury that it is not enough to remedy the problem of access.”

Gold said “the proposed IP model represents a fresh look at the issue of international trade and access, one that tries to get past the highly oppositional nature of past discussions.”

Practical Solutions for Enhancing Medicines Access

“In my view, a revision of TRIPS is highly unlikely,” said Gold. “Further, I believe that there are many flexibilities that currently exist within TRIPS that have been underutilised by low- and middle-income countries.”

According to Gold, key countries such as Brazil have not even implemented the Doha agreement on access to medicines while the sixteen member states of the African Intellectual Property Organization (known by its French acronym OAPI – Organisation africaine de la propriété intellectuelle) do not permit themselves to issue compulsory licences under Article 46 of the Bangui Agreement for the importation of medicines produced under that agreement.”

Gold added that a change in the TRIPS agreement would not be sufficient to ensure access to medicines as changing the international trade rules does not automatically translate into national legislation, and national legislation does not necessarily translate into the real delivery of medicines.

Gold pointed out that “it is not enough to pass legal measures” as indicated by the International Expert Group on Biotechnology, Innovation and Intellectual Property in its September 2008 report entitled “Toward a New Era of Intellectual Property: From Confrontation to Negotiation.”

“What is equally or even more important is to ensure that practices concerning the use of IP are in place,” he said. “Thus, changing TRIPS is unlikely to secure access to essential medicines.” While legal measures can support the adoption of “positive practices” through appropriate incentives like tax credits and grants, and disincentives like compulsory licences, “they are not self-implementing,” he said.

“What is required in the end,” he added, “is collaboration between patent holders – who also hold significant tacit knowledge – governments, and those able to deliver medicines to find sustainable solutions.”

The creation of a patent pool to deliver HIV/AIDS medicines (IPW, Public Health, 9 July 2008), as proposed by the international drug purchase facility UNITAID, would require the voluntary participation of pharmaceutical companies, generic companies and non-governmental organisations such as Médecins Sans Frontières (MSF), http://www.accessmed-msf.org/ also known as Doctors without Borders.

Gold added, “While the WHO has a clear role to play at the normative level in the access debate, practical solutions will not likely emerge from it given its mandate, financing and structure. This is not a criticism of the WHO, but simply an acknowledgement that it does not possess – in the same way that WIPO does not possess – the flexibility and administration to create and sustain partnerships.

“While pharmaceutical companies often overemphasise the importance of IP, so do many concerned with access. Only by encouraging collaboration can a solution be found,” he said. “Countries already have the tools to encourage collaborations within the existing TRIPS agreement. These should be pursued, in my opinion, rather than putting all our energies into a long and likely ineffective renegotiation of TRIPS.”

Wagdy Sawahel may be reached at info@ip-watch.ch.