Info Service on Health Issues (April 13/04)
Organised crime approach to fraudulent medicines raises concerns
The UN office on Drugs and Crime is considering making the issue of fraudulent medicines a crime. This criminal law approach to IP enforcement by conflating the issue of the quality, safety and efficacy of medicines with intellectual property rights could affect access to affordable medicines.
The following article by K. M. Gopakumar is reproduced with permission from South-North Development Monitor SUNS #7572, 24 April 2013
With best wishes
Health: Organised crime approach to fraudulent medicines raises concerns
By K. M. Gopakumar, Vienna, 23 April 2013
A draft resolution for the consideration of the Commission on Crime Prevention and Criminal Justice (CCPCJ) further blurs the distinction between criminal acts and intellectual property infringement of medicines, by proposing the involvement of transnational organised crime enforcement in addressing the issue of fraudulent medicines.
This has raised concerns over the issue of access to affordable medicines.
The 22nd session of the CCPCJ is taking place from 22-26 April in Vienna, Austria, the headquarters of the UN Office on Drugs and Crime (UNODC).
(The CCPCJ is the central body within the United Nations system dealing with crime prevention and criminal justice policy, including trafficking in persons, transnational crime and aspects of terrorism prevention. The UNODC administers the activities of CCPCJ.)
Two documents on fraudulent medicines will be considered on 25 April. The first is a report of the Executive Director of the UN Office on Drugs and Crime to the CCPCJ titled "Countering fraudulent medicines, in particular their trafficking" (E/CN.15/2013/18, hereafter "the report"). The second is a draft resolution proposed by Argentina titled "Curbing illicit trafficking in fraudulent medicines" (E/CN.15/2013/L.11, hereafter "the resolution").
Both the report and the resolution recommend the use of the UN Convention against Transnational Organised Crime as a tool to address the issue of fraudulent medicines.
The report states: "The Organized Crime Convention provides the scope for applying the Convention to serious offences that are transnational in nature and involve an organized criminal group. There is a compelling need to treat trafficking in fraudulent medicines as a serious offence established in accordance with the Organized Crime Convention".
Further, the preamble of the resolution states: "... underscoring in that regard the potential utility of the United Nations Convention against Transnational Organized Crime, in reinforcing international cooperation in the fight against trafficking in fraudulent medicines, including their illicit production and distribution, through, inter alia, mutual legal assistance, extradition and the recovery of the proceeds of crime, ..."
However, there is no shared understanding among UNODC member sates regarding the meaning or definition of the term "fraudulent medicine". The absence of clarity regarding this provides room to include infringements of intellectual property (IP) such as trademarks and patents. Thus, the adoption of the report and the resolution is expected to strengthen UNODC's criminal law approach to IP enforcement by conflating the quality, safety and efficacy (QSE) of medicine with intellectual property rights. The UNODC initiative is widely viewed as another organisational capture by the pharmaceutical companies to push the IP enforcement agenda.
The report contains five parts viz. introduction; challenges in successfully countering trafficking in fraudulent medicines; existing frameworks and the complementary role that can be played by the UN Convention against Transnational Organised Crime (CTOC); research activities on the involvement of transnational organised crime in trafficking in fraudulent medicine; and recommendations.
The report makes seven recommendations for the future work of the UNODC with regard to fraudulent medicines:
"(a) Convene joint training seminars involving law enforcement agencies, such as police, border police, customs and other relevant actors, to promote greater understanding and cooperation at the national, regional and international levels;
"(b) Provide UNODC with information and statistics on the trafficking of fraudulent medicines involving, in particular, organized criminal groups;
"(c) Inform UNODC of technical assistance needs such as training programmes and legislative drafting assistance in order to more effectively prevent and combat trafficking in fraudulent medicines;
"(d) Use relevant databases and tools already developed by competent regional and international organizations such as the European Police Office (Europol), INTERPOL, the World Customs Organization and WHO to assist in the fight against trafficking in fraudulent medicines;
"(e) Make use of the provisions of the Organized Crime Convention to more effectively investigate and prosecute activities of organized criminal groups related to the production of and trafficking in fraudulent medicines."
Further, it recommends the endorsement of CCPCJ to consider UNODC to develop additional criminal justice tools and training programmes that could be used to assess and strengthen legal and regulatory framework. Lastly, it recommends that CCPCJ encourage the Member States to provide extra-budgetary resources for the implementation of Resolution 20/6, in particular to implement the technical assistance.
MANDATE ON FRAUDULENT MEDICINES WORK
Resolution 20/6 adopted at the 20th session of the CCPCJ in April 2011 provides the mandate for UNODC to work on fraudulent medicines. The first paragraph of the preamble defines the term "fraudulent medicines". According to the preamble, "fraudulent medicines", usually referred to as "falsified medicines", include "purported medicines whose contents are inert, are less than, more than or different from what is indicated, or have expired".
This definition is problematic because the definition equates fraudulent medicines with the term "falsified medicine".
The operational paragraphs (OP) of the resolution state the following:
OP 1 urges Member States and international and regional institutions to strengthen and implement measures and mechanisms to prevent trafficking in fraudulent medicines.
OP 2 urges Member States to introduce legislation covering all offences related to fraudulent medicines such as money laundering, corruption and smuggling, confiscation and disposal of criminal assets, extradition and mutual legal assistance.
OP 3 urges Member States to review their legal and regulatory framework to provide effective legislation and improved regulatory mechanisms including strengthening of public-private partnership.
OP 4 encourages Member States to adopt measures enhancing cross-border cooperation including exchange of information, joint investigations, special investigations techniques, enforcement at national, regional and international levels and cooperation of national agencies to curb trafficking fraudulent medicines.
OP 5 invites Member States to make strong efforts to publicise the consequences of purchasing fraudulent medicines.
OP 6 invites UNODC to conduct further research in cooperation with other international organisations on the modalities of organised crime including its involvement in the issue of fraudulent medicine.
OP 7 encourages UNODC to identify key Member States in the most affected regions and to provide corresponding technical assistance upon request.
OP 8 requests UNODC to work in close cooperation with other UN bodies and international organisations, relevant regional organisations, national agencies, private sector, civil society organisations and professional associations.
ARGENTINA'S PROPOSED RESOLUTION FOR CCPCJ CONSIDERATION
The draft resolution proposed by Argentina for the ongoing 22nd session of CCPCJ contains the following OPs:
"1. Invites the United Nations Office on Drugs and Crime to convene joint training seminars involving law enforcement agencies, such as police, border police and customs agencies and other relevant actors, in order to promote greater understanding and cooperation at the national, regional and international levels;
"2. Urges Member States to provide the United Nations Office on Drugs and Crime with information and statistics on trafficking in fraudulent medicines involving, in particular, organized criminal groups;
"3. Invites Member States to inform the United Nations Office on Drugs and Crime of technical assistance needs such as training programmes and legislative drafting assistance, in order to more effectively prevent and combat trafficking in fraudulent medicines;
"4. Encourages Member States to make use of the provisions of the United Nations Convention against Transnational Organized Crime to more effectively investigate and prosecute activities of organized criminal groups related to the production of and trafficking in fraudulent medicines;
"5. Invites Member States to provide extra budgetary resources to implement Commission on Crime Prevention and Criminal Justice resolution 20/6 of 15 April 2011 and relevant subsequent resolutions;
"6. Requests the Secretary-General to report to the Commission on Crime Prevention and Criminal Justice at its twenty-third session on the implementation of the present resolution."
This draft resolution also contains eight preamble paragraphs. The first preamble paragraph recalls the relevant past resolutions. The second reiterates the importance of international cooperation to fight against illicit trafficking. The third reaffirms the willingness of Member States to cooperate on health and crime issues and in promoting access to medicines that are safe, affordable, effective and of good quality. The fourth observes that sufficient supply of certain medicines and quality assurance is still lacking. The fifth underscores the potential utility of the CTOC in reinforcing international cooperation in the fight against trafficking in fraudulent medicines. The sixth notes the strong mandate for UNODC from the CTOC. The seventh recognises the need to strengthen and implement mechanisms for tackling organised crime networks involved in the production of and trafficking in fraudulent medicines by enhancing the criminal justice of affected Member States. The eighth acknowledges the information shared during the technical conference on trafficking of fraudulent medicines held in Vienna on 14-15 February 2013.
THE CCPCJ REPORT AND ITS PROBLEMS
This report will be discussed by CCPCJ Member States this week. The second section clearly states the absence of common position on many issues including the use of the terminology, especially the term "counterfeit". The report states that stakeholders may refer interchangeably to "counterfeit", "illicit", "fake", "substandard" or "falsified medicines". It also quotes the definition used by Resolution 20/6. It further stresses the need for considering offences as serious crimes. However, this section cites the lack of adequate legal frameworks in many countries. It also states that in many countries, the penalties are not commensurate with the seriousness of the crime.
The third section of the report mentions the various existing multilateral or plurilateral initiatives on medicines such as WHO's new Member State Mechanism on substandard/spurious/falsely labelled/falsified/counterfeit medical products from the standpoint of public health (and not trade or intellectual property), the Council of Europe Convention on the Counterfeiting of Medical Products and Similar Crimes etc. However, it proposes to address the issue of trafficking of fraudulent medicines within the framework of CTOC.
The fourth section deals with research activities on the involvement of transnational organised crime. It clearly cites a figure of US$150 million as the annual import of fraudulent medicines in West Africa.
The fifth section describes the two activities carried out under the technical assistance activities promoting the use of the UN Convention against Transnational Organised Crime.
One of the important concerns with regard to the UNODC initiative on "fraudulent medicines" is the lack of clarity with regard to the term " fraudulent medicines". The preamble of the resolution 20/6 adopted at the 21st Session of the CCPCJ in April 2011 defines the term "fraudulent medicine". According to the first paragraph of the preamble of the Resolution 20/6: "...for the purposes of the present resolution and without prejudice to other accepted definitions or work in this area, ‘fraudulent medicines', usually referred to as ‘falsified medicines', include purported medicines whose contents are inert, are less than, more than or different from what is indicated, or have expired ..."
This definition is problematic because the definition equates fraudulent medicines with the term "falsified medicine".
The EU Directive on Falsified Medicine defines a "falsified medicine" as a medical product with a false representation of: (a) its identity, including its packaging and labeling, 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.
However, this definition explains terms such as "identity" and "source" in a non-exhaustive manner. Therefore, these terms can be interpreted to include infringements of trademarks or patents.
The UNODC definition of fraudulent medicine in Resolution 20/6 includes the infringement of intellectual property and therefore can be used for IP enforcement.
In other words, the definition of "fraudulent medicine" does not exclude IP infringements from the scope of the definition, and accordingly could be used to criminalise alleged IP infringement. Secondly, the definition is so broad that it includes substandard medicines within its scope. This broad scope would bring all the licensed manufacturers under the constant threat of criminal prosecution. Often, circulation of substandard products occurs without any criminal intent. Thirdly, the definition does not refer to criminal intention, i.e. mens rea, which is the constituent element of any criminal act.
UNODC's approach to the circulation of medicines with compromised quality, safety and efficacy is enforcement of criminal law especially within the framework of CTOC. According to one developing country delegate, in the absence of such clarity, the licensed producers who may infringe IP or produce and sell substandard product without any criminal intent or negligence, due to factors beyond their control, might face criminal investigation and prosecution.
The criminal law approach without looking at strengthening of drug regulatory authorities and access to affordable medicines is also mooted by the International Medical Product Anti Counterfeit Taskforce (IMPACT). The IMPACT working group has even drafted a model law. Many developing countries rejected this approach in the WHO, realizing the limitation of this approach.
(Due to protests from civil society groups working on public health and several WHO Member States, IMPACT was removed from the WHO where it was originally located.)
Another important problem with UNODC's initiative is the lack of verifiable evidence. UNODC has so far published four transnational organised crime threat assessment reports. All of these reports used data from questionable sources. For instance, the UNODC report titled "Globalization of the Crime: A transnational Organized Crime Threat Assessment" and published in 2010 cites the Pharmaceutical Security Institute (PSI) and states that: "According to the incident database of the Pharmaceutical Security Institute, countries in Asia report the largest share of counterfeits detected globally".
Two recently published reports also use the same pattern. Further, UNODC reports also use data from the World Customs Organisation, INTERPOL etc. Data from these organisations substantially includes IP infringement or violation of customs or registration laws rather than the quality of compromised medicines. Thus, public health is not their focus.
Further, UNODC also cites documents that cannot be traced. For instance, Paragraph 2 of the document circulated in the current 22nd session of the CCPCJ states: "While there remains significant gaps in our understanding of the problem, trafficking in fraudulent medicines is recognized as a major public health threat, leading to an estimated 200,000 deaths worldwide every year."
Footnote No. 2 of the document referencing the number of deaths simply cites ‘WHO2008' without citing further details of the source to help one to retrieve the document. One WHO observer disclosed that there is no such WHO study in existence.
The first round of the informal consultations on the resolution proposed by Argentina is in progress. The CCPCJ report and the resolution will be discussed at the plenary meeting on 25 April.