134th WHO Executive Board meeting – Agenda item 9.5: Regulatory system strengthening
Speaker: Rohit Malpani, Director, Policy and Analysis, MSF Access Campaign
Médecins Sans Frontières welcomes the report of the Secretariat on regulatory system strengthening, particularly its confirmation of WHO’s leadership in setting independent norms for quality control, and its call for collaborative solutions to fill the vacuum of regulatory oversight for many health products.
We wish to bring the following four points to Member States’ attention:
• Firstly, the report suggests transitioning some activities of the WHO prequalification programme to strengthened regional regulatory systems. Although MSF encourages Member States to align with this vision, we are concerned about the potential risks, should the activities of Prequalification be transitioned too prematurely. The WHO Prequalification programme has been pivotal in ensuring that affordable generic antiretrovirals meet quality standards. Close to one third of countries have very limited regulatory capacity, and they, as well as UN agencies and humanitarian organisations like MSF, will still need a strong WHO prequalification programme in the medium term.
• Secondly, Member States should allow for a potential expansion of the remit of the WHO prequalification programme, to other critical life-saving products, including biological therapeutics such as immunoglobulin serums and biosimilars, complex products like liposomal formulations, and critical anti-infectives at high risk of resistance.
• Thirdly, Member States should encourage recognition of WHO-prequalified products by national and regional regulatory authorities and networks, to avoid duplication and ensure prompt registration of life-saving products.
• Finally, as new models of financing, including a new fee-for-service structure, are considered for the Prequalification programme, fees should be set reasonably so they do not discourage small-sized companies to submit dossiers. Donor support to the programme will need to continue, ideally in a non-earmarked manner to ensure the sufficient flexibility for Prequalification to determine and address priority issues.
MSF urges Member States to support both the strengthening of regional regulatory systems long-term, and the expansion of the WHO Prequalification programme to fill the many regulatory gaps that remain.