WHO Needs Another Year To Solve Differences On Fake Medicines, Committee Decides

Country delegates gathered Saturday at the World Health Assembly decided to give another year to a working group in charge of making recommendations on falsified medicines. Unanimously, countries decided that more time is needed to reach consensual recommendations, in particular on the prickly issue of intellectual property rights.

All countries meeting in “Committee A” of the annual Assembly agreed that falsified medicines are a major public health problem especially affecting developing countries, resulting in a large number of fatalities because patients receive the wrong ingredients, the wrong dosage, or no active ingredients at all.

However, the way to address that problem remains an area of discord. Countries are trying to define the role of the World Health Organization (WHO) in addressing the problem. Some countries have found that WHO strayed into trade and intellectual property concerns, such as patents and trademarks, instead of focusing solely on public health.

Delegates in committee approved the resolution [pdf] on falsified medicines. The resolution includes details on the future role of WHO in the fight against falsified medicines, including awareness-raising among regulatory authorities, political decision-makers, health professionals and consumers, increased activities on prequalification of products, technical support for countries, and the role of WHO with its anti-counterfeiting taskforce.

The resolution now goes before the full Assembly for final approval. The WHA is meeting from 16-24 May.

All countries taking the floor advocated extending the working group for one year, keeping its initial mandate and asking for a clear schedule of meetings and that it report to the next WHA in 2012. Some strong statements were delivered on the issue of intellectual property, and the need to strengthen regulatory authorities.

In May 2010, the annual World Health Assembly (WHA) asked the WHO director general to convene a working group on “substandard/spurious/falsely-labelled/falsified/counterfeit” medical products (SSFFC). The cumbersome terminology was agreed upon at the same WHA, to address the concern of some developing countries that the past use of the term “counterfeit medicines” referred more to an intellectual property right infringement, such as patent or trademark, than a concern on quality. The working group was mandated to report at the May 2011 Assembly.

In January, member countries at the WHO Executive Board meeting raised concerns that the working group had not met yet (IPW, WHO, 19 January 2011).

The group met from 28 February – 2 March (IPW, WHO, 3 March 2011) but could not agree on specific recommendations to the WHA, and the working group, chaired by Darlington Mwape of Zambia, asked that the May Assembly consider extending the period set out in Decision WHA 63 [pdf], establishing the working group.

One of the mandates of the working group was to “examine the following matters from a public health perspective, excluding trade and intellectual property considerations.” The matters to be considered were: WHO’s role in measures to ensure the availability of quality, safe, efficacious and affordable medical products, WHO’s relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), and WHO’s role in the prevention and control of medical products of compromised quality.

IMPACT- Italy Not Far Enough for Some

The role of IMPACT, which involves law enforcement agency Interpol in the activities of WHO, has been highly criticised by some developing countries because it was deemed to focus mainly on intellectual property issues over public health issues, since law enforcement has no health expertise.

A key concern among generic-producing nations is that the counterfeit issue is being used to confuse consumers about safe and legitimate generic medicines, which are allowable after the patent expires and sold more inexpensively than the brand-name version.

On Saturday, India gave a statement on behalf of countries of the WHO South-East Asian region (SEAR). “The problems regarding access and affordability posed by high prices, weak drug regulatory infrastructure and other capacity constraints are further exacerbated by efforts from some quarters to promote deliberate confusion between intellectual property considerations and quality related issues,” the delegate said, according to his written statement [pdf].

SEAR countries “continue to hold the view that IMPACT has a predominant IPR agenda and has no mandate to be associated with the WHO in any way,” the official said. “The WHO should therefore, terminate any remaining links with IMPACT if it has to pursue its global public health mandate with undivided attention.”

IMPACT was recently relocated from WHO headquarters in Geneva to the Italian Medicines Agency in Rome. The Indian official asked that all WHO relations with IMPACT be suspended until the outcome of the working group is finalised and its recommendations endorsed by the WHA.

The Indian delegate also said IMPACT “or the bringing it into the WHO,” was an initiative taken by the WHO secretariat and not by the WHO governing bodies. He called for strengthening national health surveillance systems, drug regulatory authorities, promoting access to medicines and scrupulously distancing the WHO from IP enforcement matters.

The request to suspend relations with IMPACT was also requested by countries such as Sri Lanka, Kenya, and Thailand. Tunisia said the work of IMPACT needs to be refined and improved but recalled that IMPACT was created in the absence of consensus on an international instrument against bad medicines.

An official from Hungary, on behalf of the European Union, said the countries understand the concern on the governance aspect of IMPACT, but believed that the taskforce had been efficient and said the relationship between WHO and the taskforce deserved more discussion. France, Monaco, and Canada also supported the work of IMPACT.

Regulatory Authorities Strengthening, Affordability Key

Many of the countries that took the floor on Saturday, some of which struggled with the SSFFC terminology like a tongue twister, emphasised the role of WHO in helping countries strengthen regulatory authorities, and the absolute need to have affordable good quality medicines as the most efficient way to fight falsified medicines.

Tanzania, on behalf of the African region, said fake medicines are a major problem in Africa, and asked that an international legal instrument be developed to regulate and monitor in particular the systems of distribution of medicines.

Kenya said generic medicines are also affected by counterfeit issues and if affordable medicines were available for the population, it would be easier to control falsified medicines. Brazil asked that the fight against fake medicines be addressed in parallel with access to medicines for all, as both goals are mutually reinforcing

Interviewed by Intellectual Property Watch at the start of the WHA, Afghanistan Health Minister Suraya Dalil said that in her country, where 42 percent of the population live with less than US$ 1 a day, fake medicines are an acute problem. The country needs support to increase its capacity for testing and certifying medicines, she said, and also to be able to manufacture its own essential drugs, either with local companies or with international ones. Technical and financial assistance are keys to achieving those goals, she said.

Industry Welcomes Resolution, NGOs Advocate Drug Affordability

Pharmaceutical Manufacturers & Associations told Intellectual Property Watch afterward that it approves of the working group extension.

Mario Ottiglio, International Federation of Pharmaceutical Manufacturers & Associations associate director for public affairs and global health policy, said “it is vital for member states to agree on an appropriate long-term platform for international collaboration which puts patients’ safety at its core. This will permit the building of a truly global shared commitment to address the fake medicine issue effectively, as part of the broader effort to combat poor quality medicines. To do anything less would be play into the hands of the criminals who are profiting at the expense of patients’ health.”

A non-governmental organisation representative from Third World Network, speaking on behalf of CMC Churches Action for Health and other like-minded public interest NGOs, said a critical but currently under-stressed component to address the falsified medicines problem is to ensure the availability of medicines at affordable prices as a deterrent to engage in the business of compromised medicines, according to his written statement.

He emphasised the importance of regulatory capacity, particularly in Africa, where he said a WHO study concluded that countries did not have the capacity to control the quality, safety and efficacy of the medicines on their market.