Medicine Shortages - Growing Pressure on European Commission To Take Action in Next Legislative Cycle
On 17 May 2019, a broad group of organisations representing patients, consumers, healthcare professionals and public health advocates called on the European Commission to investigate medicine shortages and take appropriate action that complements the work undertaken by a joint task force of the heads of national medicine agencies and the European Medicines Agency (“EMA”) (see annex 1 - letter addressed to European Commissioner responsible for Health and Food safety Vytenis Andriukaitis and the Director General for Health and Food Safety, Anne Bucher). The initiative comes ahead of the European elections at the end of May 2019 which will create a new European Parliament but will also trigger the designation of a freshly composed European Commission. The letter advocates action “during the next legislative period”.
The letter reflects the position of heavyweight organisations such as the European Association of Hospital Pharmacists which, in November 2018, published the results of a pan-European survey (1,666 responses from 38 countries) on medicine shortages in the hospital sector and listed the major challenges to be tackled (annex 2). It is the latest voice in a growing chorus of calls from various sectors in favour of action at the European level. For example, in early April 2019, the European Society for Medical Oncology, published its own set of “recommendations for the 2019-2024 legislative cycle”, including the adoption of legislation for early notification requirements for medicine shortages and the creation of catalogues of shortages (annex 3).
Earlier, in February 2019, France’s pharmaceutical trade association Leem came out in favour of increased cooperation between national and European regulators to tackle what it described as a sharp increase in the number of medicines at risk of shortages (annex 4). According to Leem, in 2008 companies reported to the French medicines regulator ANSM 44 medicines of major therapeutic interest at risk of or experiencing shortages. That number grew to 538 in 2017.
Leem attributes the shortages to an expanding global demand coupled with insufficient production capacity, as well as changes in production chains, controls and regulatory obligations. It supports an EU-wide effort to monitor shortages and also recommends a boost in the EU-based production of active pharmaceutical ingredients. Additionally, Leem backs improvements to hospital public procurement mechanisms and to the exchange of information between the various stakeholders in the medicine supply chain. Leem’s proposals follow in large part the findings of a report which the French Senate released in October 2018.
The pressure on the incoming European Commission to put medicine shortages high on its list of priorities is considerable and is thrown into sharp relief by Member State initiatives such as that of Belgium which try and address medicine shortages at the local level (see, Van Bael & Bellis Life Sciences Newsflashes of 8 and 17 May 2019).