By Charlotte Roffiaen, France Assoc Santé
In France, shortages of medicines have regularly made the headlines over the past 12 months. Their numbers have indeed skyrocketed since 2008, from 44 to 868 in 2018, with a further 60% increase expected in 2019. In recent years, similar situations have been evidenced and denounced by patients, consumers, and healthcare professionals’ organisations across the European Union. Shortages have evidently become a massive access issue in Europe and their consequences on people’s health classify them among the worst public health emergencies, especially when they affect essential medicines and last for long time periods.
Shortages are not a new phenomenon. In France, HIV patients started reporting their antiviral treatments were missing in pharmacies back in 2008. That’s when patient organisations started looking into the issue, creating a Shortage Observatory to assess the entity of the problem and understand the root causes behind medicines short supplies. The relentless advocacy of civil society has helped progressively improve the applicable regulation; it now includes public service obligations on wholesalers and pharmaceutical companies such as supply obligations and limitations to parallel trade, obligation to declare any short supply of high therapeutic interest medicines (MIT) lasting for more than 72 hours, obligation to propose and implement shortage management plans (PGP), and so on.
Nevertheless, these measures have not succeeded in slowing down the exponential increase of the phenomenon. First, the controls and sanctions necessary to enforce these obligations were insufficient, which means the system partly relied on the goodwill of stakeholders. Second, some measures asked for by patient organisations, such as the compulsory stockpiling of medicines with high therapeutic interest, were still missing from the legal framework. Third, shortages often hit more than one country at the same time and sometimes have a global dimension. Trying to prevent or manage short supplies within the boundaries of France is thus not sufficient anymore.
We urgently need true cooperation at EU level, based on thorough and transparent information on the root causes of shortages in EU countries, as a group of over 30 organisations requested in a recent letter to the Health Commissioner and to DG Santé. The recommendations of the EMA / HMA Task Force on availability of medicines are a step in the right direction, but their impact is expected to be limited as they rely exclusively on the goodwill of stakeholders and Member States. Without a bold initiative of the new European Commission promoting a common policy on shortages, more and more Europeans may not have access to the essential medicines they need in the coming years.
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Charlotte Roffiaen joins representatives from the Romanian Health Observatory, the European Association of Hospital Pharmacists and the European Association of Euro-Pharmaceutical Companies to discuss the current crisis of medicines shortages across Europe at EPHA’s upcoming Universal Access and Affordable Medicines Forum “Time for a New Deal: Challenging the status quo on medicines policy” which takes place on 14 November, at Scotland House in Brussels. Norway’s view on access to medicines, the EU’s plans to tackle cancer and transparency in pharmaceuticals policy are also on the agenda.