At today’s Plenary session, the European Parliament adopted its Report on the shortage of medicines – how to address an emerging problem. 

Speaking about the vote, EFPIA Director General, Nathalie Moll said. “We are acutely aware of the impact medicine shortages can have on patients. Addressing them is a priority for the European research-based pharmaceutical industry, as was acutely exemplified by industry‘s frontline role over the past eight months to avoid any shortages of medicines during this pandemic.” She went on to say. “While some of the recommendations put forward by the European Parliament could have a positive impact in reducing medicines shortages, we are deeply concerned that other measures proposed not only fail to address the root causes of this emerging problem, but if implemented, could severely undermine the ability of our companies to innovate”.

The report underlines that the multifactorial root causes of medicines shortages need to be further assessed. This should begin with the identification of bottlenecks in the supply chain. Equally, we welcome the acknowledgment of certain supply chain practices as one of the potential causes of shortages and the need for the EU to take necessary action to tackle the issue. In this respect, we believe that more transparency is needed and we propose that the repositories system established in the context of the Falsified Medicines Directive be used to inform on the nature of drug shortages. We believe the creation of a High-level forum and a European model of the US Biomedical Advanced Research and Development Authority would be important steps in the right direction. 

The report underlines that a complete repatriation of supply chains might not be feasible in a global economy. EFPIA concurs that the EU should maintain its diverse global supply chains as driver for Europe’s welfare, resilience and as an engine for the post-COVID-19 recovery. Ultimately, forced localization of pharmaceutical manufacturing in Europe would undoubtedly have a negative impact on the competitiveness of the EU.

While the Parliament has recognised patent protection as a key incentive for companies to invest in innovation, EFPIA notes with concern that several suggestions made in the report, such as changes to EU intellectual property rules, as well as pricing and procurement policies, are disproportionate and unbalanced. Similarly, in calling for a number of regulatory reforms and sanctions for manufacturers, the European Parliament does not consider the extreme complexity of the issue, and the need to produce additional evidence and knowledge about the key drivers and extent of medicines shortages. 

Nathalie Moll concluded by saying “EFPIA welcomes initiatives to address shortages and shares a common goal with all partners in healthcare to ensure timely access for patients to high quality medicines and vaccines. Measures considered should be proportionate and provide the right conditions to support innovation and long-term sustainability of supply. This should include predictable pricing, market access and regulatory policies that reflect economic and healthcare needs across Europe. We look forward to a constructive dialogue with the European Parliament and other EU authorities to identify and implement solutions effectively addressing the root causes of this growing issue”.