Statement |

Regulatory System Strengthening: MSF intervention at 67th WHA

World Health Assembly 67 – Agenda item 15.6

Patients cannot receive proper health care without accessing safe, efficient and quality-assured health products. 

The responsibility for assessing the manufacture, distribution and use of medicines and health technologies lies with national regulatory agencies. But the financial and human resources needed for them to fulfill all their functions are lacking in many countries.

Médecins Sans Frontières believes the WHO Prequalification programme and the WHO Essential Medicines and Health Products Department play a critical role in this respect, not just in prequalifying medicines, vaccines and other health products, but also in strengthening capacity at national regulatory agencies and in providing technical support to regional regulatory harmonisation initiatives. The technical support provided to countries for the establishment of proper pharmaceutical policies, the development of adequate supply channels, and the implementation of sustainable pricing policies and of rational drug use is also valuable.

Given the importance of these programmes, it is critical that Member States fund all key activities of the WHO EMP department. Voluntary contributions from donors are not enough.  The EMP must be able to address the priority health needs of Member States, rather than being driven by its voluntary donors’ agenda. 

Member States should introduce predictable, long-term core funding that benefits the EMP department so that it can do four things:

  1. enhance the support given to national medicine regulatory agencies and regional agencies under development;
  2. expand the current portfolio of the Prequalification programme so that more health products are assessed;
  3. provide enhanced technical assistance at country level on rational drug use, pricing and procurement policies;
  4. set norms and standards for global medicines regulation through its expert committees and groups; this last activity may require coherence with harmonisation initiatives, but should deliver normative texts elaborated  independently from private and commercial interests.Patients cannot receive proper health care without accessing safe, efficient and quality-assured health products.