Generic Drugmakers, Activists Praise Lamy; Gurry Defends ‘Respect’ For IP

By William New
Generic pharmaceutical producers have grown in importance in recent years despite or because of intellectual property rights, and at their annual meeting this week in Geneva they attracted the leaders of the primary intergovernmental institutions engaged in IP rights policy.

Generic industry representatives and access to medicines activists praised an opening speech given by World Trade Organization Director General Pascal Lamy Tuesday.

Meanwhile, World Intellectual Property Organization Director General Francis Gurry on Wednesday drew applause in his closing remarks to the meeting when he said, “No one should make confusion between substandard, counterfeit medicines and generics.”

Gurry spoke as WIPO member governments debated his proposed new programme and budget. One of the key areas of debate is whether his goal of engendering “respect for IP” is a way of increasing WIPO’s enforcement efforts. “Some people think this is the artist formerly known as enforcement,” he said, alluding to the way of referencing the musician Prince after his name change.

Gurry also said he is proposing a stronger look at the “social benefits of IP.” A “very important initiative” is to implement the WIPO Development Agenda and “mainstream” development across the organisation. But, he said, “the reality is that at this moment the Development Agenda is just an idea. The task is to transfer that idea into an operational reality.”

Another goal is to build the global IP infrastructure, as the normative framework for IP has reached a “stalemate.” This includes developing global databases of patent information and terminology with broader linguistic capabilities. A key focus will be on the sharing of knowledge, he said. But WIPO also will step up its involvement in global policy debates over key issues such as public health and climate change, he said.

Lamy Offers a Possible “Opening”

While far from a radical speech, the audience found hopeful signs in Lamy’s remarks about the use of flexibilities for public health within the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Lamy spoke in some detail about TRIPS and public health at the International Generic Pharmaceutical Alliance (IGPA) conference, held on 8-10 December (IPW, WTO/TRIPS, 10 December 2008).

Alexandra Heumber of Médecins Sans Frontières said there was “an opening” in Lamy’s remarks on the so-called paragraph 6 decision of the 2001 WTO Doha Declaration on TRIPS and Public Health. The decision to offer a waiver to TRIPS rules in order to allow export of cheaper versions of patented medicines was reached on 30 August, 2003.

Heumber supported Lamy’s comment that the 30 August mechanism is not the sole solution for improving access to medicines, that stakeholders should not have blind faith in it, and that if member states request a review, then it should be reviewed.

She and other activists were favourably struck by Lamy’s statement that counterfeiting, while a problem, is clearly not a patent issue but rather related to trademarks.

“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,” Lamy said. “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.”

They also liked Lamy’s comments on exclusive rights given to drug test data. Heumber said that he said TRIPS Article 39.3 on the protection of undisclosed information should be interpreted in the light of the Doha Declaration, which called for a pro-public health implementation of TRIPS.

“As regards undisclosed information, its protection clearly forms part of the obligations under the TRIPS agreement,” he said. “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,” he continued, “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.”

Greg Perry, director general of the IGPA concurred with MSF’s reaction. “It was made clear everywhere here,” he said at the end of the meeting. “Hopefully we’re coming to an end on this.”

There were numerous other speakers at the generics industry conference, such as Skhumbuzo Ngozwana, deputy CEO of generics producer Cipla Medpro in South Africa. He described patent policy in that country and said that while fighting patent infringement is important, patent abuse also should be just as carefully scrutinised. He also said “pseudo-generics” – those actually made by brand-name companies – are an increasing trend, threatening the generics industry, and said disparagement of generics is on the rise.

Exploit the LDC Transition Period for TRIPS

Frank Schmiedchen of the German Federal Ministry for Economic Cooperation and Development (BMZ) discussed Germany’s programme to foster pharmaceutical production by using TRIPS flexibilities in developing countries. He said business opportunities are unique in least-developed countries, and that due to the long period for such countries to adopt the TRIPS agreement (not until 2016), they are allowed to re-engineer and produce any highly innovative health product legally until a minimum of 2016. Schmiedchen also encouraged development of local and regional industry, and highlighted the use of TRIPS flexibilities to their fullest extent.

William New may be reached at wnew@ip-watch.ch.