The Council of the European Union has adopted the new pharma package marking a major overhaul of the bloc’s pharmaceutical legislation aimed at improving patients’ access to safe, effective and affordable medicines while strengthening the competitiveness of Europe’s pharmaceutical industry.
The reform introduces new rules covering regulatory protection, medicine availability, generic drugs, antimicrobial resistance and treatments for rare diseases.
New Protection Rules for Medicines
Under the new legislation, companies launching new medicines in the EU will receive an eight-year data protection period, giving them exclusive rights over data generated through pre-clinical and clinical trials.
Companies will also receive one year of market protection, during which generic medicines and biosimilars cannot immediately enter the market.
An additional year of protection may be granted to innovative medicines that meet specified conditions, including conducting comparative clinical trials, carrying out clinical trials in multiple EU member states and applying for authorization early in the EU.
Medicines that address an unmet medical need may also qualify for an additional year of market protection.
The combined protection period for a new medicinal product will generally be capped at 11 years, or 12 years if a transferable exclusivity voucher is used.
EU Seeks to Prevent Medicine Shortages
The package also introduces measures aimed at improving the availability of essential medicines.
EU member states will have the ability to require pharmaceutical companies to supply medicines covered by regulatory protection in sufficient quantities to meet patient needs.
Safeguards will ensure that these requirements focus on preventing shortages and meeting patients’ needs rather than facilitating parallel trade between member states.
Generic Medicines and the ‘Bolar Exemption’
A new intellectual-property provision known as the “Bolar exemption” will allow manufacturers of generic medicines to conduct necessary studies, trials and regulatory preparations before the relevant intellectual-property rights expire.
The measure is designed to allow generic versions of medicines to become available from the first day after the relevant protection ends.
The exemption will also cover applications connected to procurement tenders.
New Incentive to Fight Antimicrobial Resistance
The pharma package introduces a transferable exclusivity voucher designed to encourage pharmaceutical companies to develop priority antibiotics and help tackle antimicrobial resistance.
The voucher can provide one additional year of market protection for another pharmaceutical product chosen by the company.
However, the measure includes a “blockbuster clause.” A transferable voucher cannot be used for medicines with annual gross sales exceeding €490 million during the preceding four years.
Additional Protection for Rare-Disease Medicines
The new rules also address orphan medicinal products*, which are medicines developed to treat rare diseases.
Such medicines will receive nine years of market exclusivity** under the new framework.
“Breakthrough” orphan medicines may qualify for an additional two years, bringing the potential total to 11 years.
A medicine may qualify as a breakthrough orphan medicine when no medicinal product has previously been authorised in the EU for the relevant rare condition and the treatment produces a clinically relevant reduction in illness or mortality associated with the condition.
A Major Overhaul of EU Pharmaceutical Rules
The Council’s adoption of the pharma package represents a significant change to the EU’s pharmaceutical framework.
The legislation combines measures intended to improve patient access and medicine availability with incentives for pharmaceutical innovation, while introducing provisions aimed at supporting generic competition and addressing antimicrobial resistance.
The reforms are intended to create a pharmaceutical system that is more resilient, competitive and responsive to the needs of patients across the European Union.
