The Polish Presidency of the EU Council hopes that, on Wednesday 4 June, the Member States will finally reach a common position on the proposals to recast the legislation on pharmaceutical products.
The aim is to get the Committee of Permanent Representatives of the Member States to the EU (Coreper) to approve a mandate to start negotiations with the European Parliament on the pharmaceutical package (see EUROPE 13645/9).
With regard to regulatory data protection, the Polish Presidency is proposing, in a compromise text dated 2 June and consulted by Agence Europe, to maintain the current period of eight years after the granting of marketing authorisation (MA) - compared to seven years in the mid-May version of the text, which provided for a bonus of one year under certain conditions.
However, the period of market protection, currently set at two years, could be extended, particularly for medicines addressing an unmet medical need.
More specifically, the compromise text provides for regulatory data protection to remain an unmodulated period of eight years, as in current legislation, while a modulation would be applied to the second year of market protection. This modulation would cover the following cases: one year of market protection would be granted to a medicine addressing an unmet medical need, or cumulatively meeting the following conditions: - clinical trials conducted in more than one Member State; - the use, in these trials, of a relevant and evidence-based comparator to support the initial marketing authorisation application; - proof that the marketing authorisation application was first submitted to a competent authority in the EU or no later than 90 days after the submission of a marketing authorisation application outside the EU.
In addition, a number of changes have been made to introduce additional safeguards in response to concerns expressed by several Member States regarding patient safety. The article in question has been amended to only allow for the ‘re-dispensing’ of certain specific medicines, and only of products bearing safety features - i.e. prescription medicines. Further provisions have also been introduced to make the mechanism more secure, in particular by introducing one time ‘re-dispensation’.
The Polish text aims to remove the possibility of imposing a penalty on manufacturers who fail to supply the European market. The Commission could, however, propose a new text providing for penalties, four years after the entry into force of the regulation and after evaluation of its effects.
With regard to the ‘transferable data exclusivity vouchers’ that the Commission could issue to manufacturers producing new antibiotics, the Polish Presidency is proposing to reduce the number to five, compared to 10 in the previous compromise texts.
In addition, on Tuesday 3 June, the European Parliament’s Committee on Public Health decided to start negotiations with the Council on the pharmaceutical package as soon as possible. The first trilogue could take place on 17 June. (Original version in French by Lionel Changeur)