SEA/RC65/10 - Reports of WHO global working/advisory groups: substandards/spurious/falsely-labelled/falsified/counterfeit medical products and strengthening drug regulatory authorities
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AbstractThe issue of substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC) has been discussed at the World Health Assembly since 2010 following the seizure in 2008 of generic medicines in transit through the Netherlands on the basis of infringement of intellectual property. Since then the lack of a uniform definition of “counterfeit” medical products and certain activities of International Medical Products Anti-counterfeiting Task Force (IMPACT) set up to combat counterfeit medical products in 2006, have engaged the attention of Member States. IMPACT and WHO’s involvement was discussed at the Sixty-third World Health Assembly in 2010. The World Health Assembly decided “to establish a time-limited and results-oriented working group on substandard/spurious/falsely-labelled/falsified/counterfeit medical products comprised of and open to all Member States” to examine inter alia WHO’s role in ensuring availability of quality, safe, efficacious and affordable medical products and WHO’s relationship with IMPACT. The Inter-Governmental Working Group (IGWG) presented its report to the Sixty-fifth World Health Assembly in 2012. Indonesia was Vice-Chair in both the IGWG meetings of 2011. There is unanimous support for WHO’s role in measures to ensure the availability of good quality, safe, efficacious and affordable medical products and concern was also expressed at the lack of sufficient financing for WHO’s work in this area. The IGWG recommendations are incorporated into Resolution WHA65.19 which urges Member States to: (1) voluntarily participate and collaborate with the proposed Member State Mechanism; (2) provide sufficient financial resources (US$ 2 370 000–3 230 000 in 2012–2013) to strengthen the work of the Secretariat in this area; and requests the Director-General to: support the proposed Member State Mechanism; assist Member States in building capacity to prevent and control SSFFC, which will necessarily involve strengthening drug regulatory authorities. At the Sixty-fifth World Health Assembly, 33 delegations made statements on SSFFC. A number of delegations emphasized the importance of WHO’s involvement in combating SSFFC and expressed their concern about the funding gap. It is important that all Member States participate, and Member States of SEA Region adequately engage in this proposed new Member State Mechanism. Member States may like to consider their support to improving access to safe, efficacious and affordable medicines of good quality by strengthening drug regulatory authorities, incorporating public health safeguards and not decreasing access through intellectual property policies. The High-Level Preparatory (HLP) Meeting held in the Regional Office in New Delhi from 3 to 5 July 2012, reviewed the working paper and made the following recommendations: Actions by Member States (1) To participate in the proposed Member State Mechanism. (2) To undertake in-depth assessments of the capacity of the national drug regulatory authorities (NDRAs) in combating SSFFC. (3) To provide sufficient human and financial resources to strengthen the capacity of NDRAs in combating SSFFC. Actions by WHO-SEARO (1) To provide technical support to Member States to undertake in-depth assessments of the capacity of the NDRAs in combating SSFFC. (2) To develop, based on evidence from the assessment in Member States, a regional medium-term strategic plan to combat SSFFC. (3) To explore the possibility of establishing a mechanism for bulk purchase of drugs and vaccines of assured quality particularly for Member States who depend on importation of drugs and vaccines. (4) To report the progress and outcome of the implementation of the regional mediumterm strategic plan to the Sixty-eighth meeting of the Regional Committee. The working paper has been revised to include discussions from the HLP Meeting and is submitted with the HLP Meeting recommendations to the Sixty-fifth Session of the Regional Committee for its consideration.
World Health Organization, Regional Office for South-East Asia. (2012). SEA/RC65/10 - Reports of WHO global working/advisory groups: substandards/spurious/falsely-labelled/falsified/counterfeit medical products and strengthening drug regulatory authorities. WHO Regional Office for South-East Asia. http://www.who.int/iris/handle/10665/128318
Gov't Doc #SEA/RC65/10