Enforcement, Creative R&D Financing Priority Issues For Public Health in 2009

The number and intensity of debates over the role of intellectual property rights in public health is set to increase in 2009.

New leadership and new mandates for key intergovernmental organisations implemented last year have created opportunity for change. And while old debates over the balance between IP rights and access to health products are not going away, this year will see more exploration at the intergovernmental level of different systems to stimulate innovation.

The debate over substandard and counterfeit drugs is a major issue to watch, with both the World Health Organization and the World Trade Organization involved in the issue and with relevant non-governmental and industry groups deeply invested in achieving differing outcomes.

Also significant is the ongoing implementation process of the WHO global strategy on intellectual property and public health – in particular an expert working group tasked with finding innovative ways to finance research on neglected diseases.

The related ideas of patent pools – in particular one announced by UNITAID in July (IPW, Public Health, 9 July 2008) – is likely to be interesting this year, as is the question of how to ensure that benefits from the use of genetic resources in health products go to the appropriate stakeholders.

Stopping Dangerous Drugs, Safeguarding Generics

“Enforcement will dominate everything” in 2009, said Tahir Amin of the Initiative For Medicines, Access and Knowledge (I-MAK) in New York. The use of the term “counterfeit” in reference to enforcement efforts, with its connotations of trademark law, will be “one of the major battlegrounds.”

“The fact that the IP enforcement agenda seems to be contradictory” to other international agreements protecting public health will “be a big issue going forward,” Michelle Childs of the Médecins Sans Frontières Access to Essential Medicines Campaign told Intellectual Property Watch.

“Counterfeit products pose a threat to patient safety and impact our industry’s ability to recover the high R&D costs for innovative therapies,” said Caroline Ruggieri of Bio-Connect.com, a pharmaceutical consulting firm. “I believe the industry will work to ensure adequate mechanisms to prevent counterfeit products from entering the market.”

The counterfeit drug issue generated consternation but no consensus at the WHO Executive Board meeting, which met from 19 to 27 January (IPW, WHO, 27 January 2009). A draft report and resolution on counterfeit drugs tabled at the Executive Board was so strongly objected to by enough member states that the secretariat is expected to write a new report in order to take into account the concerns of members.

The debate hinges on whether the term “counterfeit” – which has a legal definition linked to trademark law – adequately protects public health. Governments, mostly developing countries, as well as non-governmental entities, are concerned use of it might impede access to legitimate generic drugs and distract from what they see as the real problem, substandard (or poor quality) medications. There were also questions raised about the involvement the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) – which some felt had been unduly influenced by developed nation and industry interests – on whose technical work much of the original counterfeit report was based.

The new report being prepared by the secretariat is to be presented at the 62nd World Health Assembly on 18-27 May, where member states can then decide how to take the work forward. It will be factual and not contain a draft resolution. It is unclear how much of the old report is to be carried forward in this new draft.

Elizabeth Finney, the WHO spokesperson responsible for this issue, would say to Intellectual Property Watch only that the organisation “will carefully study the comments received” and that the “report will focus on the public health impacts of substandard, spurious, and falsely labelled products and WHO’s role in providing support to member states.” She added that “decisions on the exact contents of the document that will be tabled at a future WHA will be made in the coming weeks.”

At the same time as concerns are being raised about false brand names, the generic industry is worried about safeguarding their own market niche.

The National Association of Pharmaceutical Manufacturers, representing the South African generics industry, wrote to Intellectual Property Watch [doc] that “the disparaging of generic medicines by originator companies” could lead to healthcare professionals and patients being misled “regarding the safety, quality and efficacy of generic medicines.”

They also raised concern about “pseudogenerics” – or generic versions launched by the brand-name company a few years before the patent expires, thereby capturing a major part of the market share and preventing “real” generics from entering.

Counterfeit in other Fora

But the debate at WHO is not the only place counterfeit is likely to come up. “Other efforts may be even more important,” said Richard Kjeldgaard, associate vice president on International Intellectual Property for the Pharmaceutical Research and Manufacturers of America (PhRMA). International and national policing efforts, such as those coordinated by international police agency INTERPOL and reforms in specific countries are going to be significant.

Trademark is a “hook with which” customs officials can stop counterfeit products from entering their markets, he said, as those willing to mislead about the source of their product probably also have poor quality control.

But the customs issue has worried some.

“We have real concerns,” said Childs, “that the push for higher enforcement measures is contradictory and undermining the principles of the Doha Declaration.” This refers to the 2001 Doha Declaration on the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health [pdf].

In particular, a delayed generic drug shipment between India and Brazil was brought up at the WTO General Council meeting in early February (IPW, WTO/TRIPS, 3 February 2009) has lent weight to that concern.

MSF wrote to the European Commissioner raising the concern [pdf] that the incident not set a precedent in EU countries “to intercept legitimate trade between generic manufacturers and developing countries [that] could severely impact the affordability and availability of medicines.”

“If countries don’t have manufacturing capacity, then the trade in legitimate medicines is fundamental to ensuring access,” Childs said. “If enforcement provisions seek to impede that trade, it undermines the workability of the Doha Declaration,” in particular the “30 August decision” that allows countries manufacturing drugs under compulsory licence to export a majority of them to a country in need.

A letter was written from 16 key non-governmental agencies expressing concern on the issues (IPW, WTO, 21 February 2009).

A new IP Division director at the WTO could also have an effect on the way TRIPS discussions continue this year, as WIPO’s Antony Taubman steps into the WTO role on 1 May.

Customs interference with trade flows and shipping of legitimate products from competing nations also is the subject of concern at the World Customs Organization, which has recommended discontinuance of one committee on IP issues only to consider creating another.

Global Strategy on Neglected Diseases

Also important this year is the continuing implementation process of the WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property [pdf]. In particular, eyes are on an expert working group on innovative financing mechanisms for incentivising research on neglected diseases – created as a part of the global strategy.

The working group met for the first time just before the Executive Board in January – when they focussed primarily on procedural issues – and will not meet again formally until June or July, after the Health Assembly. However, the global strategy asks that the group submit a progress report at the May 2009 assembly, and the group chair George Alleyne told Intellectual Property Watch that online consultation processes would be occurring between up to the WHA. These will include work on substantive issues.

The question for the working group, said Childs, is “whether there will be proposals that meet the real needs of resource poor settings, both in terms of technologies and the price.” Her group is “supportive of mechanisms that del-ink the cost of R&D from the access price,” she said, including prize fund proposals from Barbados and Bolivia.

Also to come up at the May assembly are the IP issues in pandemic influenza preparedness, which proved too controversial for productive discussion at the WHO meeting on the topic in December (IPW, WTO, 15 December 2008), in particular how they will be addressed in standard material transfer agreements on genetic resources.

Patent Pools

UNITAID, an intergovernmental drug purchasing mechanism, announced it would form a patent pool in July 2008; several sources see this as an evolving project to watch in 2009.

“If the patent pool succeeds, it’s major,” said Ellen ‘t Hoen, who recently took responsibility for the patent pool at UNITAID. “It may take longer than a year, but at the end of 2009 we’ll have a good picture of whether it will succeed or not,” she explained, cautioning that it is “not just up to us, it’s voluntary: those who hold the IP will have to be willing to come to the table.”

Brand-name pharmaceutical manufacturer GlaxoSmithKline announced on 13 February that it would form its own patent pool, which is significant as it indicates not only private sector interest in such set-ups, but also innovator interest. Producers of brand-name drugs have traditionally been more inclined to traditional methods of IP protection.

Interested NGOs have hailed the move, though some have raised concerns over how well it will fit with UNITAID’s pool. James Love, in a statement for Knowledge Ecology International, said the GSK move is being “read by some public health experts as an attempt to undermine the model presented in the UNITAID patent pool.”

WIPO on Global Issues; Development Agenda

“In view of the changes at WIPO, how the work streams move forward is something to watch,” Kjeldgaard said, noting especially WIPO’s recent reorganisation under new director general Francis Gurry.

Several member states have said the first conference on Global Challenges at WIPO – to be held 13-14 July – will be significant. New Director General Francis Gurry said in an October interview with Intellectual Property Watch (Inside Views, 28 October 2008) that the new global challenges division, which is still taking shape, will include work on issues of access to medicines and access to healthcare.

Also important is implementation of the WIPO Development Agenda, launched in autumn 2007 (IPW, WIPO, 28 September 2007), which can include discussions of IP and public health. The WIPO Committee on Development and Intellectual Property, which has oversees implementation, will meet from 27 April to 1 May.

A WIPO official told Intellectual Property Watch the organisation plans to continue collaborative work with the WHO on issues where their mandates cross over.

ECOSOC, Convention on Biological Diversity

IP and public health issues are likely to crop up at other UN bodies this year as well. The UN Economic and Social Council (ECOSOC) has begun looking into intellectual property issues, most recently with a meeting on traditional medicine on 13 February in New York [pdf].

Another venue is the UN Convention on Biological Diversity, where an international regime on genetic resources is meant to be in place in 2010. That process has drawn the scrutiny of sceptical pharmaceutical and biotechnology industry lobbyists.

Depending on how such a regime is designed, said Kjeldgaard, it “could have impact on research, particularly small research organisations [and] small companies that have difficulty complying with ambiguous regulatory requirements.” But, he added, “there’s so much uncertainty…[it is] worth watching to see how it evolves, as it might or might not have IP implications.”

Meetings of the CBD expert working group on access and benefit sharing will take place from 2-8 April, and tentatively on 9-15 November.

The International Federation of Pharmaceutical Manufacturers Associations (IFPMA) is also planning to step up its activities in Geneva, as returning president Fred Hassan said in his November speech, crediting “the cycle of lP and innovation” as responsible for causing “not only prosperity, but… the rule of law, democracy, tolerance, philanthropy and care for the environment.”