After long hours of negotiations, the EU Council and European Parliament reached a provisional agreement on the morning of Thursday 11 December on the “pharmaceutical package”, a new set of rules designed to improve patient access to medicines and make the EU’s pharmaceutical sector fairer and more competitive (see EUROPE 13764/2).
Danish Minister for the Interior and Health Sophie Løhde said that the agreement “strengthen[s] incentives for priority antimicrobials, reduc[es] red tape for the life science industry, and safeguard[s] the availability of essential medicines”.
Adam Jarubas (EPP, Polish), chair of European Parliament’s Standing Committee on Public Health, stressed the need to develop innovative therapies for certain diseases. Speaking to the press, he said: “We need new innovative therapies [addressing] unmet medical needs for conditions currently without treatment, rare disease, paediatric medicines, new antibiotics. We need equal access to medicines in all Member States without delays, as differences between EU Member States can now reach up to two or more years. [...] We need medicines we can afford, meaning that competition from cheaper medicines begins immediately after an agreed deadline that protects innovation”. He said he was convinced that on these objectives “we have managed to achieve a balance in the regulation”.
Tiemo Wölken (S&D, German), rapporteur on the regulation, felt that this package “represents a major step towards a fairer and more accessible healthcare system for our citizens and, indeed, towards a modern and strengthened pharmaceutical framework”. With regard to antimicrobial resistance, the rapporteur fought to introduce the so-called ‘Netflix’ model, or subscription model, as a second tool, in addition to the transferable data exclusivity voucher. The aim is to “further fix market failures in relation to antimicrobial resistances because [...] unfortunately [...] investing in the development of a new antimicrobial is really expensive. Companies would like to sell as many pills as possible, but this [...] then increases resistance. Hence, we need a system which ensures income for the pharmaceutical companies working on them and at the same time [prevents their] overuse. With the subscription model, we do that”, he explained.
Dolors Montserrat (EPP, Spanish), rapporteur on the directive, hailed it as a “victory for patients” and a reason for Europeans to be confident: “There will now be fast and fair access to the best medicines in all 27 Member States, with more innovative medicines to treat rare diseases, paediatric cancers and to combat antimicrobial resistance”. Thanks to the Bolar exemption, “the day after a patent on a medicine expires, generics or similar medicines will be available to all citizens”, she pointed out.
Laurent Castillo (EPP, French) said that the European Medicines Agency (EMA) would have to authorise a drug in less than 180 days (compared with 210 at present) or monitor critical shortages in conjunction with EU countries. Mr Wölken also welcomed a very important point for European Parliament, namely the membership and voting rights of patients and healthcare professionals within the EMA. The regulation of medicines “remains scientifically rigorous, but socially legitimate and firmly rooted in real-world experience”, noted the rapporteur.
Regulatory protection. Under the agreement, companies bringing a new drug to market will benefit from an eight-year data protection period, which means that they have exclusive rights to data from preclinical and clinical trials. They will benefit from one year’s market protection - the exclusive right to sell a product without immediate competition from generics or biosimilars - a period that can be extended by an additional year for innovative medicines that meet two of the three stipulated conditions.
Pharmaceutical companies will be eligible for additional periods of market protection: if the product meets an unmet medical need (12 months); if it contains a new active substance, meeting a combination of conditions relating to comparative clinical trials, clinical trials conducted in several Member States and the obligation to submit an application for market authorisation within 90 days of submitting the first application for authorisation outside the Union (12 months); if the company obtains authorisation for one or more new therapeutic indications offering a significant clinical benefit compared with existing treatments (12 months).
There is a ceiling of eleven years for the total combined period of regulatory protection.
Orphan medicines intended to treat a disease for which no treatment is currently available could benefit from a market exclusivity period of up to eleven years.
Availability of medicines. To ensure the availability of essential medicines, the co-legislators retained a provision introduced by the EU Council (Article 56a) allowing EU countries to require companies to supply sufficient quantities of medicines with regulatory protection to meet patient needs. During negotiations, safeguards were added to clarify the obligations of companies and Member States and prevent Article 56a from being used for parallel trading activities.
Bolar exemption. An exemption is provided, allowing manufacturers to take the necessary steps to ensure that generic versions of a medicine can be made available from the first day after the expiry of intellectual property rights. Patent rights would not be infringed when studies, trials and other activities are conducted for the purposes of obtaining market authorisations, carrying out health technology assessments, obtaining pricing and reimbursement decisions or submitting bids in public procurement.
Antimicrobial resistance. A system of ‘transferable data exclusivity vouchers’ has been introduced, designed to encourage pharmaceutical companies to combat antimicrobial resistance by developing priority antimicrobials.
This voucher will offer companies an extra year of market protection for the pharmaceutical product of their choice. This 12-month extension may be used once only, either for the priority antimicrobial or for another centrally authorised medicinal product.
All antimicrobials must be prescribed by a doctor, and there are information requirements in the package leaflet.
When applying for market authorisation, companies will have to provide an ‘antimicrobial stewardship plan’ and include an assessment of the risk of antimicrobial resistance as part of the mandatory environmental risk assessment.
European Parliament agreed to maintain the ‘blockbuster clause’, which limits the potential impact on national health budgets by stipulating that the transferable voucher cannot be used for products with annual gross sales of more than €490 million over the previous four years.
The provisional agreement must now be approved by the EU Council and European Parliament before being formally adopted and entering into force on publication in the Official Journal of the European Union. (Original version in French by Lionel Changeur)