The EU Wednesday released a draft of its proposed overhaul of drug manufacturing laws. The changes have caused controversy among manufacturers, with some stating they will leave the region if the laws take effect. However, according to an announcement made by EU Health Commissioner Stella Kyriakides, the changes will provide EU citizens with “more accessible, affordable and innovative medicines.”
The reforms fall within the greater EU health plan from 2021 to 2027, where one of the goals is the affordability of medicine for members. This revision looks to address the shortcomings of the industry as well by increasing the supply chain in Europe so there is more access to medicine. The measure also seeks to address environmental issues and take action on antimicrobial resistance (AMR).
The hope is that the changes will benefit not just Europe but also third parties to the EU, such as associated countries, by providing a stronger global supply chain from Europe to the rest of the world. The program will include reforms to data exclusivity, meaning that other companies can use their competition work sooner. The public has viewed the changes positively after many were upset at how the health sector has struggled since the beginning of the COVID-19 pandemic.
However, the changes sparked some pushback from the drug manufacturing industry. Many of the costs are passed directly to the manufacturer, with some manufacturers considering moving away from Europe. This attitude is heightened as there are more lucrative markets in other countries, such as the largely unregulated markets in the US and China, where doing business could be more profitable. Bayer’s Pharmaceuticals CEO Stefan Oelrich stated that he hopes this is “a first draft,” and that sharing data in such a time frame could have ” a catastrophic impact for Europe.”