European Council announces progress on pharmaceutical package adoption

The European Council is set to begin negotiations with the European Parliament about the pharma package, having agreed its position on the new rules.

The proposals comprise of a regulation and directive. Once in place, the package will represent the biggest pharmaceutical reform in over twenty years. Two of its main aims is improving competitiveness of the EU pharmaceutical industry and reducing administrative burden.

The package is intended to achieve numerous goals, including ensuring equitable access to medicines, streamlining the regulatory framework, address security of medicine supply and reduce the impact on the environment.

Specifically, the proposals intend to enhance the periods of data protection that medicine developers have in the EU, such as those producing ‘game-changing’ antimicrobials and also promote research into rare diseases through improved market exclusivity for these treatments.

Ensuring medicine innovation in Europe

The mandate agreed by the EU Council of Ministers regarding revision of the General Pharmaceutical Legislation “is a vital step toward ensuring that all Europeans have timely and equitable access to safe, affordable, and effective medicines. At the same time, it strengthens the competitiveness and sustainability of our pharmaceutical sector and supports improved regulatory conditions to boost clinical research and to address public health needs,” Izabela Leszczyna, Polish Minister for Health stated.

Adopting the pharma package – European Council’s position

However, according to the European Federation of Pharmaceutical Industries (EFPIA), the EU Council of Ministers announcement “represents a missed opportunity to position Europe’s life sciences sector at the forefront of global competition”.

EFPIA reasoned that “while a significant number of Member States have acknowledged the urgency of reinforcing Europe’s competitive edge, the text falls short of delivering the bold action Europe needs”.

Furthermore, the European Council’s decision to reduce intellectual property (IP) protections for pharmaceutical companies could lower the attractiveness of investment in Europe “without addressing the underlying barriers and delays to patient access”, EFPIA commented.

As the legislative process enters its final phase, the organisation emphasised that EU decision-makers must ensure Europe offers “a predictable and globally competitive environment for research, development and manufacturing”.