EU: New ‘Pharma package’

 

The Council and the European Parliament have reached a deal on the new “pharma package,” a legislative overhaul designed to improve patient access to medicines and strengthen the competitiveness and fairness of the EU pharmaceutical sector. This comprehensive reform modernises EU pharmaceutical rules to ensure that safe, effective and affordable treatments are available across the Union, while also reducing regulatory burdens and reinforcing supply security to help prevent shortages.

Regulatory protection
Under the agreement, companies launching a new medicine will receive eight years of data protection, giving them exclusive rights to the results of pre-clinical and clinical studies. They will also benefit from one year of market protection—shielding them from immediate generic or biosimilar competition—with the possibility of an extra year for innovative products that meet two out of three specified criteria.

Availability of medicines
To safeguard the supply of essential medicines, the co-legislators retained a Council provision (Article 56a) allowing EU member states to require companies to provide adequate quantities of protected medicines to meet patient demand. Additional safeguards were added to clarify responsibilities for both companies and member states and to prevent Article 56a from being misused to facilitate parallel trade.

Bolar exemption
The package confirms an intellectual property exemption that enables manufacturers to carry out the necessary studies and trials so that generic medicines can enter the market immediately once IP rights expire. The wording has been refined, and the Council’s extension of this exemption to procurement tender submissions has been preserved.

Antimicrobial resistance
To encourage the development of priority antibiotics, the package introduces a transferable exclusivity voucher that grants an extra year of market protection for a product chosen by the company. The Parliament also accepted the Council’s “blockbuster clause,” which prevents the voucher from being applied to products with annual gross sales exceeding €490 million over the previous four years, helping to protect national healthcare budgets.

Next steps
The provisional agreement now awaits formal approval by both the Council of the EU and the European Parliament before it can be adopted and take effect following its publication in the EU’s Official Journal.