Non-governmental and industry reactions are mixed to a new report from the World Health Organization on the relationship of intellectual property rights, innovation and access to medicines in developing countries.

The comprehensive report, issued on 3 April and two years in the making, contains about 50 recommendations for making improving in the current situation but does not call for substantive changes to the existing patent system (IPW, Public Health, 3 April 2006).

Sisule Musungu, acting coordinator of the programme on innovation, access to knowledge and intellectual property at the intergovernmental South Centre, gave a preliminary reaction. He said that “although the report makes important recommendations such as on the idea on a global plan of action and the focus on WHO taking a more proactive role on these issues as well as the cautions sounded on FTAs [free trade agreements], there is an important question regarding how far the commission has taken us in addressing the challenges we face on these matters.”

Musungu said the report’s contribution should be assessed by: how far the commission has gone beyond previous efforts such as a notable report by a United Kingdom commission on intellectual property rights, innovation and public health; whether the report fulfils the commission’s terms of reference; and whether it meet the broader expectations of member governments who called for the commission at the 2003 World Health Assembly (in resolution WHA.56.27).

Ellen ‘t Hoen of Médecins Sans Frontières said the report contains strong analysis but that “the recommendations do not always follow by the same strength.” This indicates the diverging political views of the commission members, she said.

For example, ‘t Hoen said, the report talks about the importance of research and development exemptions in boosting research, but in the recommendations developing countries are only advised to consider what form of exemption they would like, which she called “very weak.”

She said the report is “very, very strong on bilaterals,” referring to bilateral trade agreements, and does not shy away from technical issues, for example, in spelling out that the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) does not require data exclusivity.

She also praised the report’s finding that there is no evidence that the TRIPS agreement has significantly boosted R&D, as pharmaceutical industry expenditure has increased but innovation has decreased. The report also includes “delivery” as part of the access problem, recognising that if innovation does not reach those in need, it is meaningless, ‘t Hoen said.

Finally, ‘t Hoen noted the report’s support for the R&D resolution proposed at the WHO by Kenya and Brazil, which has been forwarded to the May World Health Assembly. She said the report does not call for a radical overhaul of the patent system but states that some serious action is required, of which the R&D resolution could be the first part in what would be the “most logical step” for further work.

A Lost Opportunity?

James Love, director of the Consumer Project on Technology, said the topic was “extremely important,” and a “great opportunity” to address needed changes. “But the CIPIH has managed to do the minimum,” he said. “The report says many good things, and we agree and welcome many of the recommendations. But if measured by what the report could and should have done, it has to been seen as a lost opportunity – a disappointment to many.”

The minimal outcome was due to makeup of the commission membership, which had to reach consensus. “Some members were so closely tied to the status quo, there was this natural limit on recommendations,” he said. As the WHO secretariat had little interest in pushing for greater gains, lobbying by the US government and the major pharmaceutical companies “was effective in reducing the impact of the report, which is a shame, and shame on them for that.”

But Love added that “there is much to like in the specific discussions,” adding that, “we are pleased that they give a modest shove forward to continue work on creating a new sustainable global framework for supporting R&D that is consistent with both access and priority-setting.”

IFPMA Takes Aim at Report, WHO

Harvey Bale, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), called the report “meritorious,” but found fault with numerous recommendations and with the WHO itself for becoming involved in IP and trade issues.

“The report has so many unseen consequences,” Bale said in a 3 April press conference. “It is a roadmap for health but it is also a roadmap for disaster.”

“The WHO doesn’t have the in-depth expertise in this area,” Bale said. “This is why I think the report suffers in analysis.” For instance, he cited a recommendation that industry collaborate more with public-private partnerships on diseases of developing countries, and then later suggests the use of compulsory licences, which he sees as contradictory. “I have never seen in theory or practice that compulsory licence promotes R&D,” he said, though he allowed it might be appropriate in a case of pandemic or other emergency.

Bale also said the report “treats with too light a hand” proposals for medical R&D treaties, praised by Love and ‘t Hoen. Bale said if the WHO had more expertise, it would have said such proposals exist but “are not going to work.”

He also took a shot at WHO members’ decision to fund the report. “How many children could have been vaccinated by the budget that went to studying IP,” he said. “Where are the priorities? Is a health institution supposed to focus on IP?” Bale further questioned whether the WHO has a mandate to work on intellectual property, but acknowledged that it is up to the member states whether to continue the agency’s work in this area, which it began several years ago.

Bale may have reason to try to undermine the report’s credibility. Last fall, the Microsoft Word tracking text of an employee in Bale’s Geneva-based office was found in a version of the report that circulated to the 10 commission members, despite an understanding that the report would not be shared outside the commission (IPW, Public Health, 23 January 2006). Commission chair Ruth Dreifuss was said to help quell concern within the commission by barring the comments that had been submitted.

Lobbying Irregularities Downplayed

Asked by Intellectual Property Watch about the “irregularities” and whether his group’s lobbying was rendered ineffective when it was apparently caught inappropriately influencing the text and the comments blocked, Bale suggested that commissioners were encouraged to seek technical expertise on the report, and that IFPMA offered such advice. The group maintains that no wrong-doing was committed.

Bale said there is expected to be a 28 April meeting of six WHO regional groups with a few governments from each. He said that the Kenya-Brazil proposal on an R&D treaty might be approved at the WHO but would be better suited for a non-governmental framework such as the Gates Foundation.

Bale praised the report’s recommendation for stronger measures to promote research and development on ‘neglected’ diseases primarily found in developing countries, reducing tariffs on medicines in developing countries, greater harmonisation of regulatory standards on quality of medicines, fighting counterfeit medicines, and ways to keep developing country health professionals from migrating to developed nations.

But Bale criticised the recommendation that countries consider using compulsory licences, and the finding that there is a negative correlation between health and intellectual property protections. He said the recommendation for industry transparency on pricing would run into antitrust problems.

Bale warned of a “growing gap” economically between countries that have strong intellectual property systems and those that do not. He recommended that developing countries on the track to higher IP systems (such as Korea or Singapore) likely would simply “not take the recommendations.” And for about 40 least-developed countries, intellectual property protection is “largely irrelevant,” he said.

Industry Vocal in Opposition

Philip Stevens, health programme director of the International Policy Network, which receives funding from the pharmaceutical industry, echoed the criticism offered by Bale.

Stevens highlighted the report’s mention of the failure of health systems in developing countries, which he said “is a crucial reason why access to medicines is so low in many countries.” But he also criticised the report’s recommendation on the use of compulsory licensing in poor countries.

“Widespread and indiscriminate compulsory licensing would ruin the R&D environment for diseases of poverty, making it less likely that companies will get involved in the first place,” he said. “Because the threat of compulsory licensing adds a great degree of political risk to research, the industry will shift away from researching serious diseases and will instead focus more and more on diseases that carry little risk, e.g., erectile dysfunction and baldness.”

“Let’s face it,” Stevens said. “Even if medicines were free, the needy still would not have access to them.” He highlighted a competing new report by his organisation that he said “shows how developing counties impose needless barriers – such as taxes – that prevent the poor from receiving medicines.”

“The issue is not intellectual property, it is government intervention,” Stevens asserted. “Until this addressed, millions of people will die needlessly.”

As was the case before this report came out, the reason for these deaths remains a matter of interpretation.