EU governments have adopted a new set of rules — known as the “pharma package” — that would change how medicines are regulated across the bloc, including how long drugmakers can keep competitors off the market.
The package is a major reform of EU pharmaceutical legislation, with measures covering access to medicines, security of supply and incentives for innovation, the Council of the EU said in a statement on Monday.
Irish health minister Jennifer Carroll MacNeill said the reform sought to balance patient needs with maintaining a strong pharmaceutical industry in Europe.
Under the new rules, companies launching a new medicine would get eight years of data protection, meaning rivals cannot use the originator’s pre-clinical and clinical trial data to support their own applications during that period.
They would also receive one year of market protection — exclusive rights to sell without immediate competition from generic medicines or biosimilars — with the possibility of extensions that could bring the total combined protection for a new product to a maximum of 11 years, or 12 years if a separate voucher is used.
Supply duties, generics and antibiotics
EU countries would be able to require pharmaceutical companies to supply medicines that benefit from regulatory protection in sufficient quantities to meet patient needs, the Council said, adding that safeguards were included to stop the obligation being used to facilitate “parallel trade”, where products are bought in one member state and sold in another.
The package also expands the so-called Bolar exemption — an intellectual property carve-out that allows generic manufacturers to carry out studies and trials before patents and other protections expire — so that generic versions can be ready to launch “on day one” after protection ends, including for procurement tender applications.
To encourage development of new antibiotics, the rules introduce a transferrable exclusivity voucher that would give a company one additional year of market protection for a product of its choice if it develops a “priority antibiotic.”
The voucher would not be usable for products with annual gross sales above €490 million in any of the previous four years, under a “blockbuster clause” designed to limit the impact on national health budgets.
For “orphan” medicines — treatments for rare conditions — the package sets nine years of market exclusivity, with up to an additional two years for “breakthrough” orphan medicines in specified circumstances.
The regulation and directive that make up the package must still be adopted by the European Parliament before they can enter into force after publication in the EU’s Official Journal.
