Drug Shortages: International Summit

In June 2013 we co-hosted the first International Summit on Medicine Shortages with the International Pharmaceutical Federation (FIP). Recognizing that at issue are medicines not commodities and long-term strategies are needed rather than short-term quick fixes, the following recommendations were made:

1. In order to advance transparency and increase communication between all stakeholders on existing shortages, each country should establish a publicly accessible means of providing information that is:

• Timely
• As complete as possible
• Focusing on current shortages and their reasons
• Includes expected duration and responses

It may involve ministries of health, medicines regulatory authority, professional bodies and/or industry trade associations and other stakeholders. The mid- to long-term aim should be to aggregate this information at international level.

2. A global process to determine the list of Critical or Vulnerable products should be developed.

This would be most easily done by a multilateral organization within the United Nations structure and with inputs from ministries of health, medicines regulatory authority, professional bodies like FIP and industry trade associations. Definition and criteria for designation based on the vulnerability of supply, the complexity of production, number and location of sites of API and finished pharmaceutical products manufacture, medical necessity and the ability to substitute should be developed.

This list will require continuous revision and will inform regulatory responses, procurement practices and risk mitigation strategies. Each country could adapt the list to local conditions.

3. All procurers of medicines are urged to move towards active procurement processes that assure the continuity of supply of quality medicines. Elements of high-quality active procurement processes would include:

• Improved quantification including forecasting
• Direct communication between procurement agencies and manufacturers around issues of sustainable capacity
• Deliberated and considered approaches tailored to the specific situation for each product (long-term, short-term, split contracts, etc.)
• Responsible pricing that values quality
• Meaningful binding contracting

4. All countries are encouraged to remove unnecessary variability of regulatory practices within and between countries. All regulatory authorities need to advance responsible transparency in relation to all regulatory processes. Manufacturers are encouraged to find a non-threatening means to share non competitive aspects of audits of suppliers and contractors in order to improve transparency and enable coordinated responses.

5. All countries should investigate the potential to establish a national body charged with gathering and sharing information about demand for and supply of medicines within their jurisdiction. This body could also develop an ethical framework for decision making relating to resource allocation at times of scarcity. This body could also coordinate the dissemination of information about the national available stock disseminated through the whole supply chain.

6. All countries are encouraged to develop evidence-based risk mitigation strategies which might include strategic buffer stocks and stock piles, contingency planning, pandemic planning and capacity redundancy appropriate to their national needs.

More information is available in our press release, "Drug Shortages International Summit Releases Recommendations" and in the FIP Report.