Deep divisions among Member States have resulted in the Working Group on Substandard/Spurious/Falsely-labelled /Falsified/Counterfeit (SSFFC) Medical Products of the World Health Organisation (WHO) ending its three-day meeting last week with a recommendation to the World Health Assembly (WHA) this year to extend its mandate.
While there were differences among Member States over the many issues that were under discussion in the Working Group that met from 28 February to 2 March, the conflict among Member States over WHO^s relationship with the International Medical Products Anti-Counterfeiting Task-force (IMPACT) was particularly pronounced. Many Member States questioned IMPACT^s legitimacy and insisted that WHO distance itself from IMPACT^s activities.
It has also emerged that the IMPACT^s Secretariat, which was hosted by WHO in Geneva, is now (since September 2010) provisionally being hosted by the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation, based in Rome.
As mandated by World Health Assembly decision 63(10) of 2010, the Working Group met to discuss WHO^s role in measures to ensure the availability of QSE (quality, safety and efficacy) and affordable medical products; WHO^s role in the prevention and control of medical products of compromised QSE such as substandard/spurious/falsely-labelled/falsified/counterfeit medical products from a public health perspective, excluding trade and intellectual property considerations; and WHO^s relationship with IMPACT.
As Member States were unable to bridge their differences in the three-day meeting, a report (Doc. A/SSFFC/ IGWG/5) of the discussions undertaken by the Working Group will be submitted to the upcoming World Health Assembly in May this year with recommendations on "Next Steps". The report to the WHA reflects areas of agreement, issues considered by the Working Group and the conflicting positions of Member States on a number of issues over which disagreements persisted, such as on WHO^s relationship with IMPACT and the approach to terminology and definitions. The report also notes in the introductory section that "The Working Group decided to focus the discussion on identifying principles".
As "Next Steps", the report states that "In view of the need for further deliberations in order to make specific recommendations", it "requests that the World Health Assembly consider extending the period set out in Decision 63(10) in order to allow the Working Group to complete its work as soon as possible, building on the work thus far achieved".
It also states that "WHO should continue its programmatic work related to WHA mandates contained in resolution WHA 41.16, resolution WHA 47.13 and resolution WHA 61.21" and that "These resolutions are not related to IMPACT". It further adds that "Mechanisms adopted by WHO to fulfill its mandate should ensure transparency and inclusiveness in their conception and composition, avoiding the emergence of conflicts of interest in the actors involved and should guarantee oversight of its activities and accountability".
WHO^S RELATIONSHIP WITH IMPACT According to some sources, examination of WHO^s relationship with IMPACT consumed a significant amount of time of the Working Group, with discussions often being tense and bordering on the emotional.
[WHO^s involvement in IMPACT was tendentious even at the WHA. IMPACT is a multi-stakeholder initiative, initiated without a mandate from the World Health Assembly, with a heavy private-sector presence. The G8 countries and the European Union, among others, have identified IMPACT as an important initiative in the context of the Intellectual Property (IP) enforcement agenda, leading to concerns that WHO is being used as a front by IMPACT to validate its activities that are aimed at protecting IPRs].
Discussions on the links that WHO should have with IMPACT split the Working Group into two camps, namely, one camp unequivocally calling for WHO to disengage from IMPACT, while the other supporting WHO^s continued engagement with IMPACT. Supporters of IMPACT, however, did acknowledge the need to reform IMPACT. The Africa Regional Office (AFRO), in its statement at the meeting, qualified its support of IMPACT. It recommended that the mandate, role and status of IMPACT be redefined in accordance with the governance structure of the WHO to ensure accountability to Member States. It also called for transparency and participation in its decision-making processes, reporting mechanism and funding. It added that the composition of IMPACT should also be reviewed, pointing out that the five working groups were either chaired by developed countries or by the industry or by other organizations, with WHO playing a "peripheral role".
According to some sources, AFRO^s call for reform hit a dead-end, as it emerged that WHO had little authority over IMPACT and cannot "unilaterally change the terms of reference" of IMPACT.
Some countries proposed the formation of an intergovernmental mechanism to replace IMPACT when looking into spurious/falsely-labelled/falsified/counterfeit (SFFC) medical products, removing "substandard" and placing it in a separate category of compromised QSE medical products.
According to some delegates, several developing countries also requested Dr Margaret Chan, the WHO Director-General, to exercise her administrative authority to disassociate WHO from IMPACT. This request led Dr Chan to claim that WHO had already taken some steps to distance itself from IMPACT. She pleaded against the request, arguing that no single position had emerged regarding IMPACT, the delegates said.
[Despite Dr Chan^s assertion, WHO^s links with IMPACT continue visibly. For instance, IMPACT^s website is hosted by WHO, and Dr Carissa Etienne, the Assistant Director-General, Health Systems and Services of WHO, continues to Chair IMPACT^s Planning Group. While WHO-IMPACT links continue, IMPACT^s Secretariat, which was located in the WHO, is now provisionally being hosted by the Italian Medicines Agency (AIFA), the national authority responsible for drug regulation, based in Rome, as many Member States questioned its legitimacy and insisted that WHO distance itself from IMPACT^s activities.]
The distinct positions and proposals in the Working Group are reflected in the Working Group^s report to the WHA: "Following a general discussion, there was no consensus on WHO^s relationship with IMPACT. The positions ranged from disengagement from, to continued engagement, with IMPACT. Some Member States suggested a moratorium on WHO^s involvement in IMPACT activities until this issue is duly assessed by the Working Group, while other Member States supported WHO^s continued involvement. Some Member States proposed an intergovernmental mechanism to discuss the issue of SFFC. Some Member States acknowledged the need to reform IMPACT. However, it was noted that WHO cannot unilaterally change the terms of reference of IMPACT."
The report further states: "Several Member States recognized that there have been benefits to some countries; several Member States, however, expressed their concerns about the controversial nature of the work of IMPACT and confusion between public health goals and commercial interests."
(A developing-country delegate said privately that despite the lack of consensus on the WHO^s relationship with IMPACT, the "political message" to the WHO Secretariat has been made clear.)
TERMINOLOGIES AND DEFINITIONS According to some sources, some of the time of the Working Group was spent attempting to bridge differences over terminologies and definitions.
The WHA Decision had not defined the scope of the term "medical products" and thus it fell on Member States to define it. The scope of "medical products" was one of the few areas on which agreement was reached in the Working Group. On this, the report notes: "For the purpose of this Working Group, it was agreed that the term medical products refers to medicines, vaccines and in-vitro diagnostics".
According to some sources, several countries sought to expand the scope to include "medical devices". While the attempt was not successful, a footnote to the agreed definition of the Working Group leaves the option of expanding the scope to include medical devices in the future. The footnote states: "This may also include medical devices at an appropriate time in the future".
Divergences also surfaced over the manner in which medical products with compromised QSE should be referred to. This was a contentious issue even at the 2010 WHA, which saw a group of developing countries voicing concern about WHO promoting an IP enforcement agenda under the guise of dealing with compromised medical products, calling for WHO to discontinue the use of the term "counterfeit". This was opposed by some other countries.
[The only multilaterally agreed definition of "counterfeit" is in the TRIPS Agreement wherein the term refers to a specific category of trademark infringements. WHO^s use of the term "counterfeit" to refer to QSE-compromised medical products led to concerns that WHO was conflating the issue of QSE with Intellectual Property Rights (IPRs).]
The irreconcilable differences during the WHA were provisionally diffused with agreement to substitute the term "counterfeit medical products" with substandard/spurious/falsified/falsely-labelled/counterfeit medical products (SSFFC), pending agreement by the Working Group.
The first meeting of the Working Group was not able to reach agreement on the matter.
The Working Group discussed use of the terms "substandard" and "falsified". On the former, discussion took place on the basis of a WHO definition developed by the Expert Committee on the Specification of Pharmaceutical Preparations in October 2010 as follows: "Substandard medicines are pharmaceutical products that do not meet their quality standards and specifications. Each pharmaceutical product that a manufacturer produces has to comply with quality assurance standards and specifications, at release and throughout its shelf-life, according to the requirements of the territory of use. Normally, these standards and specifications are reviewed, assessed and approved by the applicable national or regional medicines regulatory authority before the product is authorized for marketing."
Use of the term "falsified", suggested by the WHO Secretariat in document A/SSFFC/WG/3 Rev. 1, received the support of Canada and the European Union in particular, with the former presenting principles in relation to "falsified" medical products, while the latter presented a legal definition for consideration of the Working Group.
Elements proposed in relation to "falsified" medical products are reflected in the report: "With regard to falsified medical products, some Member States proposed the following non-exhaustive elements of a definition: a falsified medical product gives a false representation of its identity and/or source and/or record keeping for traceability; pretends to have been assessed and approved by the competent regulatory authority, pretending to be a genuine quality product; has an intention to deceive by a fraudulent activity; is falsified for profit motives, disregarding public health and safety; and that disputes concerning patents or trademarks must not be confused with falsification of medical products."
However, with no consensus on the matter, the report simply notes: "Differences remained among Member States on the appropriate terms to be used to represent medical products of compromised quality, safety and efficacy".
WHO^S ROLE IN ENSURING QSE AND AFFORDABLE MEDICAL PRODUCTS Deliberations on WHO^s role in QSE matters also saw the Working Group divided over approaches to deal with the problem of proliferation of compromised medical products.
The report of the Working Group captures these differences. Under the section on "WHO^s role in measures to ensure the availability of quality, safe, efficacious and affordable medical products", the report notes: "Some Member States stressed that the improvement of access to affordable, quality, safe and efficacious medicines is an important element in the effort to prevent and control medicines with compromised quality, safety and efficacy."
"Overall, WHO should continue to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems which includes national medicine policies, health risk management systems, sustainable financing, human resource development and reliable procurement and supply systems, and to enhance and support work on pre-qualification and promotion of generics, and efforts in rational selection and use of medical products. In each of these areas, WHO^s function should be: information sharing and awareness creation; norms and standards and technical assistance to countries on country situation assessment; national policy development; and capacity building, supporting product development and domestic production".
On "WHO^s role in the prevention and control of medical products of compromised quality, safety and efficacy such as substandard/ spurious/ falsely-labelled/falsified/counterfeit medical products from a public health perspective, excluding trade and intellectual property considerations", the report states: "Some Member States expressed their desire to set up an intergovernmental negotiating body to draw up legally binding instrument at the international level designed to prevent the manufacture, export, import, or trade of counterfeit medical products on international markets and in international trade and regulate and oversee supply and distribution networks".
[According to some sources, this proposal was rejected by several developing countries that argued that such an instrument would legitimise WHO^s involvement in the various "anti-counterfeiting" initiatives (which is focussed on IP enforcement) when it should be focusing on QSE matters].
The report further states: "Some Member States stressed that the improvement of access to affordable, safe and efficacious medicines is an important element in the effort to prevent medicines with compromised quality, safety and efficacy".
The Working Group also "considered the future role of WHO" in dealing with substandard and SFFC medical products under the headings of "Information and awareness creation"; "Norms and standards"; and "Technical support to countries".
On each of the headings, the report elaborates on the issues considered: "Information and awareness creation: For substandard medical products, WHO should be a global convenor for information exchange and awareness creation, including through the International Conference of Drug Regulatory Authorities".
"In addition, for SFFC products, WHO should also promote and support awareness raising among regulatory authorities, political decision makers, health professionals and consumers; create a global surveillance and alert system, gathering and disseminating reliable and objective data on SFFC products; and act as a global convener dedicated to combating other SFFC products from a public health perspective". > ? "Norms and standards: For substandard medical products, WHO should develop/update/promote tools and guidelines for quality assurance and GMP (Good Manufacturing Practice), especially addressing the issues of bio-equivalence and inter-changeability, bio-similars and COPP certificates. WHO should intensify activities on pre-qualification of products and quality control laboratories, including specialized laboratories as centres of excellence."
"In addition, for SFFC products, WHO should develop/update/promote tools and guidelines for combating SFFC medical products, including tools for sampling and surveillance of the market and guidelines for good distribution practices for internet sales, importers and brokers".
"Technical support to countries: For substandard medical products, WHO should continue the programme of supporting the assessment of national regulatory authorities, leading to plans of action for strengthening them and monitoring their progress. WHO should increase its efforts to build national and regional regulatory infrastructures and capacity, including the national capacity to implement and enforce the regulations. Technical assistance should focus on quality assurance, safety and pharmacovigilance systems. Technical support to national regulatory authorities should be expanded in the areas of good governance and transparency issues including use of IT-enabled systems, and strengthening national medicine quality control laboratories. WHO should also continue to support regional and sub regional harmonization initiatives and expand their scope to cover aspects of implementation and enforcement of regulations. Training programmes should focus on good manufacturing practice (GMP) and pharmacovigilance. In undertaking the above activities, WHO should intensify its international cooperation and its international cooperation and collaboration".
"In addition, for SFFC products, WHO should also assist countries in identifying gaps in national legislation and regulatory structures, training programmes, support to linking national regulatory structures with other national organizations involved in fighting SFFC medical products, and providing support for the establishment and accreditation of national and international quality control laboratories able to analyse SFFC medicines."
