EU wants to ensure that there are medicines and affordable prices

According to a statement, the Member States voted in favour of the new pharmaceutical package, which reformes EU pharmaceutical legislation and wants to ensure fair access to safe, effective and affordable medicines across the EU.

The legislation, which will still have to go through the European Parliament’s crisis, also seeks to “impel the competitiveness of the pharmaceutical industry, reducing regulatory burdens and enhancing security of supply in order to prevent and manage shortages”.

Companies introducing a new medicinal product to the market will benefit from an eight-year data protection period, which means that they will have exclusive rights to data from preclinical trials and clinical trials.

As regards antibiotics, for example, the pharmaceutical package introduces a modality that encourages pharmaceutical companies to contribute to the fight against antimicrobial resistance by developing priority antibiotics.

On the other hand, in order to ensure the availability of essential medicines, EU countries will have the power to require pharmaceuticals to provide medicinal products that benefit from regulatory protection in sufficient quantities to meet the needs of patients.

The pharmaceutical package includes an exemption from intellectual property which allows manufacturers to take the necessary measures, such as studies or trials, to ensure that generic versions of a medicinal product can be made available the first day after the expiry of intellectual property rights.