Toronto International Medicine Shortage Summit Recommendations
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(24.06.13) The two-day medicine shortage international summit I described in my blog June 21 was the first of its kind to address the increasingly severe problem of medicine shortages worldwide. Attendees represented an impressive diversity in geography and professional expertise. They hailed from four continents and fifteen nations, and included 65 professionals invited because of their interest and expertise in the issue of medicine shortages. They represented pharmacists, physicians, public health officials, patient advocates, governmental elected officials, officers involved in medicine procurement, governmental regulatory officers, medical association professionals and representatives from the pharmaceutical industry including brand name and generic medicine producers.
Out of that process came a series of recommendations to deal with the problem of medicine shortages in the short and long run. The recommendations, which were announced June 21, will provide helpful suggestions to countries dealing with shortages within their own borders. In addition, for shortages which are increasingly global in nature the recommendations provide the framework for organizations and structures to address this area. The report of the summit follows.
RECOMMENDATIONS OF THE INTERNATIONAL SUMMIT
OF MEDICINES SHORTAGES
“Recognizing that medicines should not be considered solely as commodities and the free market does not achieve social goals for medicines. There are both Short-term solutions (fixing current shortages) and Long-term strategies (preventing future shortages)
The Summit recommends that the following approaches should be investigated.
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
- As complete as possible
- Focusing on current shortages and their reasons
- Expected duration and responses
It may involve Ministry of Health, Medicines Regulatory Authority, Professional Bodies and/or, Industry Trade association and other stakeholders. The mid to long-term aim should be to aggregate this information at an international level.
A global process to determine a 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 Ministry of Health, Medicines Regulatory Authority, and Professional Bodies like the International Pharmaceutical Federation (FIP) and Industry Trade associations.
Definition and criteria should be developed 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.
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.
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…)
- Responsible pricing that values quality
- Meaningful binding contracting
- 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
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.
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.
The purpose of the Summit was to provide a forum to discuss the causes and impacts and to develop a means to address medicine shortages with a variety of stakeholders from around the world, including governments, medical practitioners and industry.
Based on my observations of this talented group of professionals at work, I believe the purpose was achieved. This does not however represent a solution to the problem. It represents a first attempt by this intelligent thoughtful group that will serve us well. It is not the last step, but the first step. We need to pursue this problem with doggedly determination and persistence until it is solved. We should understand that success is unlikely to come quickly or easily. Medicine shortages affect people’s lives with adverse effects on health and suffering. It is important therefore that while understanding the need for patience, we preserve the important sense of urgency needed to get things done.