Implementing the recommendations of the Lancet Commission on Essential Medicines Policies
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Dear E-druggers
This week's Lancet has an editorial and a letter (and response) that deal with recommendations of the Lancet Commission on Essential Medicines Policies (see http://www.thelancet.com/commissions/essential-medicines).
The editorial notes the adoption by WHO of the recommendations: "WHO should evolve the WHO/UN Prequalification Programme to maintain a moving focus on new essential medicines." Here's the detailed justification from the Commission's report:
" Broaden the WHO/UN Prequalification Programme
In the face of weak national regulatory systems, many countries rely on WHO to verify whether specific selected medicines, vaccines, and in-vitro diagnostic products meet international quality standards. There is substantial opportunity to strengthen and expand this existing programme.
WHO's process of prequalification for participating in international tenders for UN procurement began in 1987 with childhood vaccines.239 Prequalification of medicines started in 2001, initially because of the very small number of affordable products available for procurement by large-scale HIV treatment programmes such as the Global Fund. By August, 2015, 420 products had been prequalified by WHO, including 262 for HIV, 76 for tuberculosis, 41 for malaria, and 41 for other conditions.240 WHO prequalification of diagnostic products has also expanded, focusing mainly on in-vitro diagnostics for HIV, malaria, and hepatitis C. As of August, 2015, 38 medicine quality control laboratories were prequalif ed by WHO. Procedures have been established for rapidly assessing products that have already been approved by a stringent regulatory agency, medicines urgently needed when prequalified products are not available, and products for emergency use, such as diagnostic tests and investigational products for the Ebola virus.
The effect of the prequalification programme is far-reaching; for example, prequalified vaccines now immunise 64% of infants worldwide.241 Without prequalified products, largely from Indian generics manufacturers, widespread affordable access to antiretrovirals would not have been possible. Quality standards used in prequalification have also been adopted by other institutions, including NMRAs, donors such as the Global Fund and UNITAID, and the MPP. The prequalification programme is a concrete application of WHO's global norms and standards for medicines quality and safety (panel 10). It has positioned WHO as a global regulatory agency and has greatly shaped the world's generic markets, driving down costs while ensuring the quality of products.244 It has also become an important training ground for regulators and inspectors, paving the way for regional harmonisation.245
The Commission believes that the WHO/UN Prequalification Programme can and should evolve to address a wider range of essential medicines, at least until international standards have been established and the global generic market has developed sufficient capacity to produce and distribute adequate supplies of quality, safe medicines. For example, assessments of new generic versions of first-line antiretrovirals can now be left to stringent national authorities or regional networks. The focus of WHO's programme should then shift to other priority medicines, such as generic insulin, other biosimilars, and newly developed essential medicines that still pose challenges to NMRAs. The programme's quality standards and public reports should be used as the basis for regulatory convergence and reciprocal recognition; its Public Assessment Reports and Public Inspection Reports can serve as examples for all NMRAs. The transparency initiatives of the European and Australian regulators can also serve as exemplars in this regard.246 A multilateral financing mechanism would enable the prequalification programme to evolve in this way-not merely increasing its existing activities but moving towards the analysis of selected new essential medicines independently from individual donors and manufacturers alike."
The letter (and reply) relate to what are now defined as "substandard and falsified medical products" (no longer as " substandard, spurious, falsely labelled, falsified, counterfeit medical products" or SSFFCs). The Commission's recommendation was that " Payers and procurement agencies must adopt good procurement practices that incorporate effective and transparent quality assurance mechanisms." Here's the detailed background in the Commission report:
" Establish good procurement practices at all levels
Good procurement practices are a crucial tool to assure product quality and safety, protecting against various problems, including corruption.247 Many international organisations (such as the Global Fund, UNITAID, the US PEPFAR, the UN Population Fund, the StopTB Global Drug Facility, Médecins Sans Frontières, and the International Committee of the Red Cross) have implemented strict guidelines that require procurement only of products with stringent regulatory agencies’
approval, WHO prequalification, or interim approval (eg, by a WHO Expert Review Panel).248
Many LMICs have centralised medicines procurement agencies, which provide the opportunity to apply good procurement practice.124 An increasing number of national procurement agencies are applying similar policies, insisting on products that meet prespecified quality standards. The Mission for Essential Drugs and Supplies in Kenya has been a pioneer in this regard. Panel 11 describes how strict quality requirements and frequent controls have reduced the percentage of quality failures.
Many procurement guidelines exist, but major challenges remain in implementation, as quality procurement is complex and costly.249 Corruption in procurement represents a major obstacle for both national and international agencies and contributes to problems in quality and safety as well as efficiency.250 The Commission believes that countries moving towards UHC must invest in improving procurement processes for quality-assured essential medicines. The use of pooled procurement can contribute to improved affordability. Quality assurance mechanisms as described previously can help to attain the ultimate goal. Coordinated international and national eff orts are required to achieve system-wide and sustainable improvement in procurement practices.251"
This is well-timed to appear just before the World Health Assembly convenes in Geneva (22-31 May 2017 - http://apps.who.int/gb/e/e_wha70.html), where a number of essential medicines issues will be debated, including:
WHA70/20 - Addressing the global shortage of, and access to, medicines and vaccines (http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_20-en.pdf)
WHA70/21 - Evaluation and review of the global strategy and plan of action on public health, innovation and intellectual property (http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_21-en.pdf)
WHA70/23 Add.1 - Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_23Add1-en.pdf)
WHA70/25 - Global vaccine action plan (http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_25-en.pdf)
Regards
Andy