Experts In Geneva: Substandard, Falsified Medicines Not About IP

Falsified and substandard medical products continue to be a global concern, and how those products are characterised is important to avoid confusion, particularly with intellectual property rights infringement. A panel convened by Brazil, India and South Africa yesterday at the World Trade Organization looked at the implications of a new definition of such products at the neighbouring World Health Organization.

WHO members at their 2017 World Health Assembly simplified the definition of what had been called “substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC)” medical products. At issue was the inclusion in the definition of “counterfeit,” a term that relates to trademark infringement under WTO rules.

The new working definition [pdf] is “substandard and falsified medical products” and includes three descriptions: substandard medical products, unregistered/unlicensed medical products, and falsified medical products.

Roger Kampf, counsellor in the WTO Intellectual Property, Government Procurement and Competition Division, chairing the panel, noted the importance of the issue of falsified and substandard medicines, and mentioned a recent side event to the World Health Assembly on access to quality medicines in Africa, and a Ministerial Declaration [pdf] which was approved during the event (HPW, Africa, 23 May 2018).

The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) considers two cases of trademark infringement, Kampf explained. One is ordinary trademark infringement, and the other one is counterfeit trademark. The latter is described by a deliberate effort to give the impression of being a genuine product, deploying a slavish copying of a trademark, which leads to a confusion between the genuine products and the copy.

According to Kampf, trademarks serve to protect against IP infringement but they can also serve the pursuit of the public interest.

WHO Has Public Health Focus Only; Access Issues Key

Michael Deats, group lead for Substandard and Falsified Medical Products at the WHO, said that during the controversy about the definition of substandard and falsified medical products, in 2012, the WHA established the Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit/medical products. He added that the mechanism excludes all IP and trade considerations. At the time it was recognised that WHO does not have expertise in those areas and deferred to the WTO.

He mentioned two reports published last year on the issue: a report on the WHO Global Surveillance and Monitoring System [pdf] for Substandard and Falsified Medical Products, and a study [pdf] on the public health and socioeconomic impact of substandard and falsified medical products.

There are some limitations to analysing data, according to Deats, when trying to evaluate the prevalence of those medical products is the information is relying on different definitions, standards, and collection protocols.

The WHO Global Surveillance and Monitoring System publication points to three reasons leading to the emergence of substandard and falsified medical products, he said. The first of those is lack of availability, acceptability, and affordability of medicines; second is the lack of technical capacity, and third is poor governance practices, such as poor procurement, unethical practices, and corruption.

According to the publication, substandard medical products are made by registered manufacturers, but they do not meet approved quality standards, for a variety of reasons, such as poor manufacture and faulty packaging.

Falsified medicines, meanwhile, masquerade as medical products, and are deliberately designed to deceive consumers. “They may contain amounts of active ingredient that are either dangerously high or ineffectively low,” may contain contaminants, or no active ingredients at all, the publication said.

Focus on Public Health Prime, But No Justification of Infringement

Carlos Correa, recently elected executive director of the South Centre, said the concept of counterfeit medicines was introduced in the WHA first during a 1985 conference organised by WHO with experts on the rational use of drugs, and it took over 20 years to get the concept out of the WHO.

The new definition adopted in 2017 is well aligned with the concepts of the member state mechanism, which focuses on the protection of public health, he said. The fight against counterfeit products aims to protect the interests of trademark owners, and are about private rights, and this objective should not be pursued at the WHO, he argued.

The presence of the word counterfeit in the definition of falsified and substandard medical products sent the wrong message to many countries, and introduced confusion, said Correa. Estimates of financial damages brought by counterfeit medicines to pharmaceutical companies are misrepresenting real losses, he said, pointing to a methodology issue.

The differentiation between IP rights infringement and public health issues in falsified and substandard medicines is not a justification of counterfeiting, which should be duly sanctioned, Correa added.

IFPMA: IP Not Related to Falsified Medicines

Cynthia Genolet, senior manager for regulatory and health policy at the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), confirmed industry’s view that the issue of falsified medicines concerns every therapeutic area.

Manufacturing and distribution of falsified medicines affects every therapeutic area, she said, and represents a crime against patients, leads to resistance to treatments such as antibiotics, provokes illness, disability, and even death.

The new WHO definition of falsified and substandard medicines is in line with IFPMA’s principles on falsified medicines, and IFPMA welcomes the new approach taken by the WHO definition, she said. Patents have nothing to do with falsified medicines, which are a public health issue not an IP issue, Genolet stressed, while not mentioning trademarks.

Fighting falsified medicines implies a global coordination, an empowerment of regulators, and the joint forces of all stakeholders, she said, calling on countries to ratify the 2011 Council of Europe Medicrime Convention on the counterfeiting of medical products and similar crimes involving threats to public health.

She also mentioned the Fight the Fakes campaign launched in 2013, which now has 36 partners, since the International Alliance of Patients Organization joined in May.

Trademark Infringement

Following a question about the possible overlap of trademark infringement and falsified medicines, Deats said overlaps happen and in the WHO experience, member states take a different approach to this issue, and will use whatever legislation is available to tackle it. The WHO approaches the issue from the public health perspective, he emphasised.

Correa said the important thing is that trademark infringement is not regarded as the essential element to determine whether a medicines is falsified or not. The actual composition of the medicines is the determining factor, he said.

Deats added that each participating country of the member state mechanism has a focal point in regulatory agencies. Most of the reported cases are about falsified medicines, he said, however the most serious cases tend to be about substandard medicines.

For Genolet, trademarks can be used as a tool to spot falsified medicines.

 

Image Credits: Catherine Saez