Myths to be dispelled on article 85 of the Pharma Directive, so called “Bolar”
Medicines for Europe is committed to improving public health through improved access, availability and affordability of medicines, in line with the pharmaceutical strategy for Europe.
In the context of the new EU pharmaceutical legislation, this document provides an economic analysis of the extension of regulatory data protection periods proposed in the European Parliament, which have strong political support. These extension proposals derive from a misunderstanding about their concrete impact on the cost and access to medicines (see explanation below) due to the complex interplay between the EU pharmaceutical
legislation and other patent and SPC laws.
The revised Pharmaceutical Legislation must deliver more access to medicines, fair competition and prevent artificial extensions of monopolies beyond what the EU system foresees.
In order to effectively allow timely access to generic and biosimilar medicines for patients and achieve the stated objectives of the ‘Bolar exemption’ (ie. early generic/biosimilar development and approvals for immediate competition after Intellectual Property expiry), it is pivotal to ensure
that the final revised Bolar leave no room for diverging interpretations in different Member States and provide clear, unequivocable provisions removing any grey area or legal uncertainty that may allow the use of ‘patent linkage’ to delay competition
The Biosimilar Market Access Committee (Biosimilar medicines Group, a Medicines for Europe sector group) undertook a 2023 Biosimilar market review consisting of updates on biosimilar medicines policy across Europe (28 European countries).
The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy interventions (e.g. pricing and reimbursement, procurement, prescribing and dispensing) to enhance biosimilar medicines use and competition in the biologics market in Europe.
The Generic Market Access Committee (Generic medicines Group, a Medicines for Europe sector group) undertook a 2023 Generic medicines market review consisting of updates on generic medicines policy across Europe (28 European countries).
The highlights of this overview have been consolidated below and illustrate both key challenges and recommendations on how to improve specific policy interventions (e.g., pricing and reimbursement, procurement of medicines) to ensure access to medicines across Europe.
Medicines for Europe welcomes the introduction of harmonised labelling, notably regarding recycling symbols which are sometimes already present in national legislations or the blue box – for example, in Bulgaria, France, and Austria.
The proposal, however, also introduces a requirement to provide information on the material composition, as well as information regarding the manufacturer and its contact details. We are concerned by the introduction of that information as there is limited space available on the packaging of pharmaceutical products.