UN Office Of Drugs And Crime Enters Debate Over Fake Medicines And IP

The Vienna-based United Nations Office on Drugs and Crime (UNODC) has been working for several years to fight “fraudulent” medicines in the global supply chain. But an alleged new draft model legislation it is developing includes intellectual property rights, an issue which has led to intensive debates in other international fora. This week, a closed-door UNODC informal expert group drafting the model legislation is meeting in Vienna.

The Second Informal Expert Group Meeting to Review Draft Model Legislative Provisions to Combat Fraudulent Medicines is scheduled to take place from 8-10 December, according to a copy of the agenda.

The draft model legislation is available here.

The little-known UNODC is waging the UN’s global fight against organised crime. In 2011, its member states passed Resolution 20/6, setting a mandate for the organisation on “countering fraudulent medicines, in particular their trafficking.” Such products are tied to organised crime, economies, and public safety. Resolution 20/6 is available here [pdf]. UNODC has developed model laws for a range of other crimes, such as trafficking in persons or money laundering.

Background information on UNODC’s work on fraudulent medicines is available here. The UNODC could not be reached for this story by press time.

The Fight over IP Rights

The new draft legislation appears to have added intellectual property rights into the work of the UNODC effort against fraudulent medicines. The latest draft also makes a change to cover “medical products”, which appears to go beyond the 2011 mandate to address fraudulent “medicinal” products.

The World Health Organization, among others, had a protracted disagreement in the past over how to define the problem, eventually settling on referring to it as SSFFC – “substandard/spurious/falsely-labelled/falsified/counterfeit” products. A key element of the WHO debate was that the organisation does not have responsibility or expertise for dealing with IP rights. And under the World Trade Organization, ‘counterfeit’ refers only to trademark violations and does not deal with the quality of the product, recognising that agency’s lack of expertise in assessing, for instance, quality of pharmaceuticals.

The new draft model legislation shows an awareness of the debates that came before, stating: “The term fraudulent medical product is not in universal use. Also used are the terms falsified medicines (Falsified Medicines Directive)[1], counterfeit medical products (Medicrime Convention)[2] and Substandard/spurious/falsely-labelled/falsified/counterfeit (WHO MSM)[3].”

“The term fraudulent medical product is similar in meaning to the Medicrime Convention meaning and the Falsified Medicines Directive meaning,” the UNODC draft says.

But the draft states that it leaves open the possibility for each member state to implement the measure as it sees fit, using whatever term they prefer nationally.

European Inside Track?

Further concern has been raised about participation in the informal expert group, as representatives from large parts of the globe and several stakeholder sectors appear to not be represented. It is not clear how the group members were chosen, but membership was said to reflect a strong European – and in particular French – presence.

Initiating the UNODC process was a Paris-based group called the Institute for Research Against Counterfeit Medicines (IRACM). According to its website, IRACM is itself an initiative of French pharmaceutical manufacturer Sanofi, and is led by Bernard Leroy, a former UNODC official. IRACM posted a note on its website about this week’s meeting. Leroy previously worked [pdf] on the UNODC’s hardline war against narcotics, which might explain a tough approach on fraudulent medicines.

Major influencers in the UNODC group’s work include the French government, Interpol (based in Lyon), and the Council of Europe (based in Strasbourg). The Council of Europe Medicrime initiative in 2010 set the first international standard for criminalising the manufacturing and distribution of counterfeited medicine risking public health (IPW, European Policy, 24 April 2010). Interpol has made a priority of fighting against medicines crimes, having helped with World Health Organization in the past. In October, it held a conference entitled, Global INTERPOL Conference – Ten Years of Combating Pharmaceutical Crime: Review and Prospects.

And today, several European pharma industry groups published an announcement that they are joining forces against “counterfeit” medicines. The European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Generic medicines Association (EGA) said they will be joining the the European Stakeholders Model. The stakeholder model was established for the implementation of the EU Falsified Medicines Directive (Directive 2011/62/EU), with participation from supply chain stakeholders, the release said.

The UNODC effort might be seen by some observers as another “forum-shopping” effort by northern governments and industry seeking in part to protect markets. In addition to WHO and the Council of Europe, the Brussels-based World Customs Organization had an ill-fated foray into the issue several years ago which was defeated by several developing countries (IPW, Enforcement, 9 July 2009, and IPW, Inside Views, 24 April 2013).

On a separate note, a senior UNODC official, John Sandage of the United States, this month became the top official for patents at the World Intellectual Property Organization.

EU Text with an IP Twist

The latest UNODC draft copies almost verbatim the definition of “falsified medicinal products” agreed under EU law. But it changes it to “fraudulent medical products,” and it removes a statement of exclusion of intellectual property infringement that also ensured that “unintentional quality defects” were not criminally punished.

This table shows the comparison:

EU definition of “falsified”

UNODC/Irish definition of “fraudulent”

Falsified medicinal product:   Any medicinal product with a false representation of:   (a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;   (b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder;   or   (c) its history, including the records and documents relating to the distribution channels used.   This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.’

Falsified medicinal Fraudulent medical product:   Means any medicinal medical product with a false representation of:   (1) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;   (2) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorization holder;   or   (3) its history, including the records and documents relating to the distribution channels used.   This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.’

 

It is notable that the UNODC effort stemmed from work of Argentina several years ago that ostensibly attempted to go in the opposite direction from this latest draft. Argentina appeared to drop the effort and instead hosted a WHO group on the issue.

Other fora, including an international pharmaceutical industry group, have sidestepped IP rights in their efforts against fake medicines. The industry-led Fight the Fakes campaign distinctly says “Fake medicines have nothing to do with patents,” and “This campaign is not a forum for intellectual property (IP) protection.”

And an academic and health professions consensus, published here, also avoided inclusion of IP rights.

According to a source, an official at the Irish Medicines Board wrote the new draft: Hugo Bonar of the Irish Medicines Board, who was formerly a principal in drafting the Council of Europe’s Medicrime Convention. This could not be confirmed by press time. But the properties underlying the Microsoft Word text of the document shows “Irish Medicines Board” as responsible for the original text.

A July meeting of the group was almost exclusively European representatives, and led to the current draft text, according to sources. A report on that meeting was published in a blog by Stefano Bonino, a research associate in the School of Applied Social Sciences at Durham University (US).

An exception to the view in July was presented by Prof. Amir Attaran, Canada Research Chair in Law, Population Health and Global Development Policy, Faculties of Law and Medicine; University of Ottawa. Attaran served as a lead consultant to the group.

Attaran presented an alternative view that did not include IP rights, and attempted to dissuade the group from moving forward with it, the source said. But his proposal was rejected and he appears to be out of the group.

Attaran recently published a paper on Model Law in Medicine Crime, available here. And in 2012, he and others published a plan for a global treaty against these types of medicines in the British Medical Journal, available here.

The Meeting this Week

This week’s group has somewhat more diversity than the July meeting, still heavily European led by France, IRACM, and the Council of Europe. Other countries represented include Belgium, Cambodia, Ireland, Israel, Jordan, Niger, Nigeria, Singapore, United Kingdom, and the United States. Also represented are the New Partnership for Africa’s Development (NEPAD) and the Pharmaceutical Security Institute, a pharma industry group.

There do not appear to be representatives from the major developing countries, foundations, or health advocacy groups, among others.

 

[1] Directive 2011/62/EU of the Parliament and of the Council of 08 June 2008 amending Directive 2011/83/EC on the Community code relating to medicinal products for human use, regarding the prevention of the entry into the legal supply chain of falsified medicinal products (The Falsified Medicines Directive). Official Journal of the European Union, at http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf

[2] Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health and similar crimes. Moscow, 28.x.2011, at Conventions.coe.int/treaty/EN/Treaties/Html/211.htm  

[3] World Health Organisation (2014). Substandard/spurious/falsely-labelled/falsified/counterfeit medical products, at http://apps.who.int/gb/ssffc/