Seven European Supply Chain Organisations Adopt Constructive Approach to Tackling Medicine Shortages
- 09/12/2019
- Articles
In an unusual joint move, seven European organisations which represent a range of stakeholders in the medicine supply chain call for a dialogue with European and national authorities in hopes of finding solutions to prevailing medicine shortages (see, attached press release of 6 December 2019). The seven organisations take a stance on behalf of suppliers of innovative medicines, generic medicines, biosimilars, vaccines and over-the-counter medicines as well as wholesalers, parallel traders and pharmacists. They indicate to prefer a dialogue that creates results over an approach that involves “placing short term disproportionate requirements on manufacturers and supply chain stakeholders that could have opposite effects to the ones intended”.
An example of such a short term and disproportionate requirement seems to be in the making in the Belgian federal house of representatives where a committee of legislators has already voted a first time in support of a measure that attempts to stamp out supply quota systems while paying little attention to a range of other possible causes of occasional shortages.
The appeal of the European organisations comes ahead of a meeting of the European Employment, Social Policy, Health and Consumer Affairs Council on 9 and 10 December 2019. Health ministers will pursue avenues for strengthened cooperation to improve access to medicines (see, Van Bael & Bellis Life Sciences Newsflash of 26 November 2019). Medicine shortages feature as a prominent topic under that umbrella.
For their part, the seven organisations list a number of what they refer to as “root causes” of medicine shortages which include a list of factors of a regulatory, production, quality, economic and supply chain nature (see, attached position paper).
Given the diversity of causes of medicine shortages, the solutions advocated by the seven organisations are equally multi-faceted. They express support for:
- EU lines of communication which, in turn, imply pan-European cooperation, a European definition of what constitutes a shortage of medicines, a European reporting and monitoring system, the identification of high-risk medicinal products, and the creation of reasonable security measures, incentives and penalties;
- Regulatory flexibility which involves a case-by-case approach to specific shortage situations;
- Efficient use of the “repeat use” procedure which involves reliance on the mutual recognition procedure more than once for subsequent applications to other Member States in relation to the same medicinal product;
- Incentives for essential low-price products;
- A predictable and sustainable pricing and reimbursement environment; and
- Adequate information to all stakeholders, including healthcare professionals, patients and suppliers of alternative products to those under scrutiny.