The EU’s Council and Parliament have reached agreement on major reform of EU pharmaceutical rules, to increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive.
“The deal demonstrates the EU’s commitment to both innovation and to ensuring that patients in Europe have access to the medicines they need,” said Denmark’s minister for health Sophie Løhde, for the EU presidency: “We are strengthening incentives for priority antibiotics, reducing red tape for the life science industry, and safeguarding the availability of essential medicines.”
The deal also seeks to boost the competitiveness of the pharmaceutical industry by cutting regulatory burdens and strengthening security of supply to prevent and manage shortages.
Under the text agreed by the co-legislators, companies placing a new medicine on the market benefit from an eight-year data protection period, meaning they have exclusive rights to data from pre-clinical tests and clinical trials.
They will also benefit from one year of market protection (the exclusive right to sell a product without immediate competition from generic medicines or biosimilars), which may be extended by an additional year for innovative medicines that satisfy two out of three conditions.
To ensure the availability of key medicines, the co-legislators have kept a provision introduced by the Council (article 56a) giving EU countries the power to require companies to supply medicines benefiting from regulatory protection in sufficient quantities to meet patient needs.
Following negotiations, safeguards have been added to the text clarifying obligations for companies and member states, and preventing the use of article 56a as an opportunity for parallel trade.
The pharma package includes an intellectual property exemption allowing manufacturers to take the necessary steps (such as studies or trials) to ensure that generic versions of a medicine can be made available on day one after the intellectual property rights have expired.
The co-legislators have clarified the wording of this provision, and have maintained the Council’s extension of the scope to include submissions for procurement tenders.
The pharma package introduces a new transferrable exclusivity voucher incentivising pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics.
Under the agreement reached between the Council and the Parliament, this voucher will grant companies one additional year of market protection for a pharmaceutical product of their choice.
The Parliament has also agreed to maintain the Council’s proposed ‘blockbuster clause’, which limits the potential impact on national healthcare budgets by stipulating that the transferrable voucher cannot be used on products with annual gross sales of more than €490 million in the preceding four years.
The ‘pharma package’: new EU rules on medicines explained (background information)
