The 11th Annual International Generic Pharmaceutical Alliance Conference — Geneva


Ladies and Gentlemen,
It is a pleasure for me to make this keynote speech at the annual conference of the International Generic Pharmaceutical Alliance.

Although your interests are admittedly much broader, my intervention this morning will focus on the interface between trade-related intellectual property rights and access to medicines — an issue of direct relevance to your industry.

My starting point today is the WTO's core mission of opening trade, which intersects with health in many ways, none of which can be treated in an isolated manner.

International trade helps improve the health conditions of many people both indirectly — through increase in incomes — and directly, through imports of health-related products or through health-related services.

Public health is a key value whose importance is recognized in all WTO Agreements, starting as far back as 1947 with the GATT that confirmed the right of WTO members to give priority to health policies even if it leads to trade restrictions. This was reconfirmed in 1995 in the then new agreements on trade in services (GATS) and on intellectual property rights (TRIPS).

Intellectual property rights, as other matters covered by the WTO Agreements, constitute only one piece of a much bigger puzzle that determines the level of access to medicines by patients in a given country.

Other pertinent factors include the existing infrastructure in a country and its national health system in general, or the transparency and efficiency of the procurement regime. Recently attention has also focused on existing tariffs on imported healthcare products whose reduction or even elimination could facilitate their accessibility. For an objective evaluation of the situation, we thus need to pay attention to various factors, as well as to the relevant domestic policies put in place by governments.

Among these factors, the issue of TRIPS and public health is certainly one of the most emotive and, consequently, frequently debated issues.

As recognized by the Doha Declaration on the TRIPS Agreement and Public Health, and reiterated by several World Health Organisation Resolutions, we are talking here about a delicate balancing act between guaranteeing the protection of intellectual property rights as an important incentive for the development of new medicines on the one hand, and addressing concerns about the potential impact on prices for such medicines on the other hand.

I am happy to note that the European Generic Medicines Association's recent report on patent-related barriers is drafted along similar lines. It recognizes the role of patents to promote innovation in the pharmaceutical sector and to recoup R&D investment, but also calls for generic competition to be available immediately after patent expiry.

That the debate on intellectual property and public health is sui generis has been explicitly recognised by WTO members when they confirmed that medicines are not just an ordinary tradable commodity.

The 2001 Doha Declaration on the TRIPS Agreement and Public Health backed the carefully negotiated balance of rights and obligations in the TRIPS Agreement. It provided a number of important confirmations and clarifications, including the right of WTO members to grant compulsory licences, the freedom to determine the grounds for such licences and the definition of national emergencies, as well as the freedom to adopt the appropriate exhaustion regime without challenge.

Since its adoption in 2001, there have been concrete examples of the use of the flexibilities incorporated in the TRIPS Agreement at country level, including allowing parallel imports, defining patentability criteria, and permitting exceptions to patent rights, such as the regulatory review exception.

The WTO dispute settlement mechanism has also confirmed these flexibilities. But it is also true that not every WTO member has yet taken the necessary steps at national level to avail itself of the existing flexibilities.

Let me now turn to the Paragraph 6 System, established under the General Council Decision of August 2003. This system was used for the first time in September 2008 to ship generic medicines from Canada to treat HIV/AIDS patients in Rwanda.

At the same time we have seen criticism expressed on the cumbersome and complex nature of this mechanism which would “hardly ever work” in the words of some critics.

It is precisely to address these kind of situations that WTO members agreed to subject this system to periodic review. I would note that WTO members did not raise concerns during the last annual review of the operation of the system and instead, led by the African Group, reaffirmed the system two years after its adoption.

This may be linked to the fact that the use of the Paragraph 6 System is confined to specific and well-defined circumstances, thus keeping the burden on potential users with fewer administrative resources to a minimum. In fact this system constitutes an additional flexibility to many that are already in the TRIPS Agreement, including as recognized and clarified in the Doha Declaration on the TRIPS Agreement and Public Health.

In any event, the system is far from being the sole solution to problems encountered in the public health sector. But this does not mean that we should have a blind faith in its success. Just like any WTO agreement, the Paragraph 6 System should be periodically reviewed and lessons drawn from these evaluations so that the WTO can continue its effort to make it work as a contribution among others to enhancing access to medicines.

I would like to briefly add the WTO's perspective to three issues which are often debated these days outside the TRIPS Council and which I know are on your mind.

First, as regards undisclosed information, its protection clearly forms part of the obligations under the TRIPS Agreement. Thus, test data submitted to obtain the marketing approval for pharmaceutical products are, under certain circumstances, to be protected both against unfair commercial use and disclosure. This has led to questions as to how such protection must be provided, an issue which is not explicitly addressed by the TRIPS Agreement.

While there has been some debate as part of the preparatory process leading to the adoption of the Doha Declaration in 2001, there is as yet no confirmed WTO jurisprudence or authoritative guidance on this question, other than that the application of the pro-public health interpretation in the Doha Declaration clearly covers the TRIPS Agreement as a whole.

As regards the more general concern often expressed with regard to “TRIPS plus” provisions in FTAs, certain of the provisions concerned may potentially have a bearing on access to medicines, as well as on the generic industry. At the same time, the developed country members participating in such FTAs have more recently confirmed their commitment to access to medicines for all, stating that such provisions are not meant to affect the ability of the parties to take measures to protect public health. The WTO's role in all this remains limited: the TRIPS Agreement tells us that members are free to adopt higher standards of protection. Therefore, we can at best monitor the content of such FTAs and offer a platform for discussion, as we do, for example in the trade policy reviews of our members. Any more ambitious initiative has to come from the membership, the WTO being a member-driven organization.

I would finally like to briefly take up the combat against counterfeit medicines which is being intensively debated these days. We certainly all share the common goal to keep counterfeit medicines out of the market, as they can have serious public health consequences.

I believe we also concur in recognizing that the effective enforcement of intellectual property rights, in particular trademarks, constitutes a powerful tool to combat counterfeit medicines.

At the same time, I have noticed the concerns expressed by some of you about an overly extensive interpretation of the term “counterfeiting”, potentially leading to confusion with cases of ordinary patent infringement and thus impeding generic competition.

Those issues are currently not debated in the TRIPS Council. But I can safely say here that the TRIPS Agreement gives a clear meaning to the term “counterfeiting”, linking it directly to trademarks. I am convinced that we can all join forces to continue the fight against counterfeit medicines through the appropriate means, including through the protection and enforcement of intellectual property rights as provided for in the TRIPS Agreement.

To conclude, I would like to share with you a cautiously optimistic assessment of the current state of play in the field of access to medicines. Important steps have been taken in the WTO and elsewhere since the adoption of the Doha Declaration in 2001. Access to medicines has been improved through a major reduction of prices, enhanced international funding, a greater recognition of the need to find a balance within the intellectual property system, as well as the use of some of the TRIPS flexibilities by certain WTO members.

But although the situation has improved over the last couple of years, the continuous and constructive engagement of all relevant stakeholders would still be required. This clearly includes the generic industry, which is playing a vital role, as underlined by its important market share in many countries. Only joint efforts will lead to further improvements in access to medicines for patients around the world. That's the common endeavour that, I believe, unites us all.

I wish you a rich debate over the next few days. Thank you for your attention.

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