TWN Info Service on Health Issues (May13/01)
Argentina’s draft resolution on “fraudulent medicines” withdrawn
Vienna, 29 April, (K.M. GopaKumar) – A draft resolution proposed by Argentina on “fraudulent medicines” at the 22nd Session of the Commission on the Criminal Prevention and Criminal Justice (CCPCJ) was withdrawn in the absence of consensus.
The 22nd session of CCPCJ was held in Vienna on 22-26 April 2013.
The proposed resolution on “fraudulent medicines” titled “curbing illicit trafficking in fraudulent medicines” proposed the use of the UN Convention against Transnational Organized Crime (UNCTOC) to address the issue of “fraudulent medicines”. In the absence of conceptual or legal clarity on the term “fraudulent medicines”, the initiative by the UN Office on Drugs and Crimes (UNODC) has raised concerns related to access to medicines (SUNS#7572). UNODC’s work program on “fraudulent medicines” is believed to be an attempt to promote intellectual property enforcement standards by conflating the quality, safety and efficacy (QSE) of medicines with intellectual property protection and enforcement.
According to the Secretariat there are three options based on the practices at CCPCJ in the absence of a consensus on a resolution. First, the sponsoring Member State(s) can withdraw the resolution. Second, the sponsor(s) can propose a voting on the resolution. Third, if there is a consensus in the plenary the consideration of the resolution can be postponed to the next session of the CCPCJ. In this case Argentina, the sponsor of the fraudulent medicines resolution exercised the first option and withdrew the draft resolution.
Even after the withdrawal of the draft resolution, UNODC's mandate under the CCPCJ Resolution 20/6 which was adopted in 2011 is still a matter of concern because that resolution defines "fraudulent medicines" in a manner that includes intellectual property (IP) enforcement rights of the pharmaceutical IP-holders. However, this resolution does not provide a mandate to UNODC to extend the UNCTOC framework to address "fraudulent medicines".
This article details the five days of contentious but short negotiations on 22-26 April that failed to reach consensus on two issues viz. the definition of the term “fraudulent medicines” and the mandate for the UNODC to carry out technical assistance by using extra budgetary resources.
UNODC Member States such as China, India and Iran expressed concerns on the potential involvement of the pharmaceutical industry in the technical assistance. According to these countries a broad mandate to receive extra budgetary resources would pave the way for funding from organizations having direct or indirect commercial interest such as pharmaceutical transnational corporations or the foundations controlled by them.
During the negotiation at the Committee of the Whole (COW) on 23 April, consensus was reached to replace the preamble Paragraph (PP) 3 with a new definition on “fraudulent medicines”. According to this new amendment, “Stressing that for the purposes of the present resolution and without prejudice to other accepted definitions “fraudulent medicines” also referred to as “falsified medicines” include medicines which are inert or different from what is labelled in a manner that poses danger to health or safety and are of compromised quality, safety and efficacy, with criminal intent,”. Further, a footnote was added to this paragraph based on the proposal from India.
According to this footnote, “fraudulent medicines as medicines where the contents are inert, less than indicated, more than indicated, different than indicated, misbranded, or expired. It does not include adequate generics labeled as generics, even if produced in contravention of intellectual property law. It does not include traditional medicines, which are what they purport to be but which may not be clinically effective for the purposes they are generally used. It is intended to address only cases involving criminal intent (Mens Rea) and not unintentional and mistakes made in content and dosage”.
This footnote and the last sentence in the PP3 was introduced by India which proposed this definition from a UNODC document titled “Transnational Organized Crime and Fraudulent Medicines “ presented at the 21st Session of the CCPCJ on 23-27 April 2012 (E/CN.15/2012/CRP.4). This footnote explicitly excludes intellectual property infringements, substandard medicines and traditional medicines from the scope of the definition.
[However, the Secretariat while circulating the redrafted resolution did not include the language of the footnote and only cited the document number at the footnote. India raised this issue from the floor on 25 April. Even after India’s intervention the Secretariat refused to put the text of the definition in the footnote. The Secretariat displayed the text in the footnote on screen, not in the document, only after India’s intervention on 26 April. Similarly after India’s intervention on 25 April on the footnote, Argentina stated that it is ignorant of the decision to accept the footnote and the accompanied text. However, the language in the footnote continued to be an issue of contention through out the informal consultation. Both Argentina and France wanted to renegotiate the definition during the informal, which was rejected by India. The Secretariat also expressed their disappointment on the footnote to this writer.]
According to sources, India refused to negotiate on the bracketed language without the recognition of the footnote. India conveyed to the sponsor of the draft resolution (Argentina) as well as France, which attended the informal consultation, that it was not ready to reopen the language, which had already agreed to by the COW.
Another issue of contention was related to the operational paragraph (OP) 5 on the financial resources for the technical assistance activities. The original OP 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”. During the negotiation words “and other interested donors” were added after the words “Member States” without the standard caveat “in accordance with the rules and procedures of the United Nations”. Further, the term “interested donors” is also a deviation from the standard language used in other CCPCJ resolutions i.e. “other donors”.
India also proposed an OP 5 bis which stated, “Request the UNODC to take necessary steps to avoid conflicts of interest while carrying out the technical assistance programs and also limit the technical assistance activities to address the trafficking of medicines with compromised QSE with criminal intension”.
In the light of the lack of consensus at the 22 April negotiations at the COW Argentina proposed the bracket on OP 5 bis (indicating no consensus) and India also bracketed the words “other interested donors” in OP 5.
the negotiation at the COW led to the following language in OP 5:
“invites Member States [and other interested donors] to provide
extra budgetary resources for the purposes of the present resolution
and Commission on Crime Prevention and Criminal Justice resolution
20/6 of 15 April 2011 in accordance with the rules and procedures
of the United Nations, including those for avoiding conflicts of interest;
India insisted on the importance of OP 5 bis because the words “interested donors” paves the way for financial resources from pharmaceutical companies. Further, according to sources, India also stated in the informal consultation that it is not even comfortable with the standard use of “other donors” because it includes the private sector. As a compromise India proposed the replacement of term “interested donors” with “international organisations”. India also wanted to have clear language on conflict of interests.
On 26 April China stated that the issue of conflict of interests is important and the concern is about the conflict of interest of the donors rather than the staff of UNODC.
Iran also aligned with the concerns expressed by India and China.
There was a last minute attempt by France, while the final plenary was in session, to reach a consensus on the resolution by proposing the deletion of the definition and focussing only on technical assistance. This failed to garner consensus. The negotiation on 23 April resulted in consensus on the following Preamble paragraphs (PP) and OPs. The new language introduced during the negotiation on 23 April is shown in italics.
Both the title and PP1 were retained without any change. However, the words “a heinous form of transnational organised crime” were deleted from PP2 and a new sentence was added. PP2 reads: “Reiterating the importance of international cooperation to fight illicit trafficking in fraudulent medicines, which has severe consequences, as a public health risk, with those affected suffering serious health consequences or even death, in terms of a loss of confidence by the general public regarding the quality, safety and efficacy of pharmaceutical products and in terms of higher health care costs …”
from the original draft resolution was deleted and replaced with a
new PP4 which reads: “Expressing its concern also over the risks
posed to human health and safety by fraudulent medicines in all stages
of the supply chain and in particular, their trafficking, advertising
and distribution, …”
PP7 changed the original version by removing the reference to the Chair’s statement at the technical conference of February 2013. It also replaced the word “acknowledging” with “taking note”. It now states: “Taking note of the report of the Executive Director on countering fraudulent medicine, in particular their trafficking including the technical conference on the trafficking in fraudulent medicines, held in Vienna on 14-15 February 2013, …”
Changes were also made to the OP1 of the draft resolution and expanded the scope of cooperation with other national and international organisation to organise joint training. However, the amended OP1 also restricted the scope of the training seminars to trafficking in fraudulent medicines with compromised quality, safety and efficacy with criminal intention. OP1 now reads: “Invites the United Nations Office on Drugs and Crime in cooperation with relevant international organizations to convene joint training seminars involving law enforcement agencies, such as police, border police and customs agencies and other relevant actors such as the competent national authorities that regulate medicines, in order to promote greater understanding and cooperation at the national, regional and international levels of trafficking in fraudulent medicines with compromised quality, safety and efficacy with criminal intention ; …”
There were no changes in OP2 and OP3:
OP2: “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; …”
OP3: “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; …”
OP4 diluted the language of the draft resolution by replacing the words “to make use” with “to take into consideration” the provisions of UNCTOC and now reads: “Encourages Member States, as appropriate, to take into consideration the provisions of the United Nations Convention against Transnational Organized Crime and of relevant regional instruments to more effectively investigate and prosecute activities of organized criminal groups related to trafficking in fraudulent medicines when this is carried out by an international criminal organization; …”
Further, a new OP4 bis was introduced: “Also encourages Member States to cooperate with other UN bodies engaged in the issue of fraudulent medicines, such as WHO and INCB; …”
(INCB is the International Narcotics Control Board, a quasi-judicial expert body established by the Single Convention on Narcotic Drugs of 1961. It consists of 13 members who are elected by the UN Economic and Social Council and who serve in their personal capacity, not as government representatives. Three members with medical, pharmacological or pharmaceutical experience are elected from a list of persons nominated by the WHO and 10 members are elected from a list of persons nominated by Governments. Current members are from Australia, the US, Russia, France, South Africa, India, Egypt, Germany, Thailand, Indonesia, Belgium and Colombia with one vacant seat.)
OP6 “Requests the (UN) 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.”
Ultimately there was no consensus and Argentina withdrew its proposed resolution. Vigilance by developing countries, however, is still needed because UNODC's mandate under the CCPCJ Resolution 20/6 of 2011 does define "fraudulent medicines" in a manner that includes IP enforcement rights.