Recently, the European Commission published a proposal to replace the Transparency Directive (Directive 89/105/EEC). The Directive, which was adopted in 1989, regulates the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems.
The Commission’s aim is for faster Markey entry for medicines and proposes streamlining and shortening national pricing and reimbursement decision processes. According to its Pharmaceutical Sector Inquiry from 2009, delays in pricing and reimbursement decisions can extend to 700 days for innovative drugs and 250 days for generic drugs. This results in the delay of the marketing of medicinal products which in turn slows down the availability of valuable treatments for patients.
The Commission claims that the replacement of the Directive, which was designed to reflect the pharmaceutical market conditions prevailing more than twenty years ago, is necessary to take into account the evolution of the pharmaceutical market and of national policies to control public expenditure on medicines.
The main objectives of the proposal are to:
- shorten time limits for national, regional or local decisions on pricing and reimbursement from 180 days to 120 days of innovative medicinal products and 30 days for generic medicinal products (in particular when the price of the reference product has already been approved or it has been included in the national health insurance system;
- prevent barriers to pharmaceutical trade through reducing any interference of patent and safety issues with pricing and reimbursement procedures;
enforce these new time limits as current deadlines are frequently exceeded. Member States will have to ensure that rapid and effective remedies are available to the applicant in the case of non-compliance with the time limits with a national body having the powers to take remedial measures such as:
- interim measures to correct the alleged infringement or preventing further damage to the interest concerned;
- damages to the applicant in the case of non-compliance with the time limits;
- imposing a penalty payment which would act as a deterrent to further infringements;
- require member states to notify national pricing and reimbursement draft measures to the Commission to facilitate compliance from the beginning require Member States to regularly report on their decisions and the time involved;
- ensure legal clarity and consistency with the Court of Justice case-law and clarifying the scope of transparency obligations;
- and address the uncertainties relating to innovative pricing and reimbursement procedures (e.g. exclusion of tendering and of managed entry agreements from the cope of the Directive.
It is noteworthy that the proposals do not extend to medical devices. The applicability of the new Directive to the medical devices market was considered but later discarded due to the specificities of this market.
The Directive will now be subject to debate within the European Parliament and the Council of Ministers. If adopted, implementation is expected to begin in 2014 with a deadline for transposition by EU Member States in 2015.