The co-legislators are beginning their reform of rules on the transparency of measures that regulate the pricing of medicines. The discussions ahead are likely to be difficult.

Under EU legislation, member states are free to take measures to manage the consumption of medicines, regulate their prices and determine conditions for their public financing. To do so, they evaluate the cost-effectiveness of authorised medicines and their usefulness over the short and longer term compared with other medicines of the same therapeutic class. Because these national measures can create trade barriers, the EU has adopted legislation imposing basic transparency conditions for procedures so that decisions on pricing and the reimbursement of medicines do not lead to discrimination against imported products. This includes, for example, setting time limits for decisions and requiring an explanatory statement based on objective and verifiable criteria. Directive 89/105, currently in force, is no longer adapted to the market, however, if only as a result of the emergence of generic drugs.

The Commission’s proposal, adopted on 1 March, therefore provides for shorter deadlines. For originator medicines: it plans to reduce from 90-180 days to 60 days the limit for decisions on pricing, 60 days for decisions on reimbursement and 120 days for combined decisions, to make innovative medicines available to patients more quickly and to reward the pharmaceutical industry. For generic drugs, time limits would be reduced to 15-30 days. If a member state undertakes a procedure to evaluate the relative effectiveness and usefulness of a medicine, the limit is set at 90-180 days.

SUBSIDIARITY PRINCIPLE FLOUTED

Two member states have adopted a reasoned opinion concluding that the draft directive infringes the subsidiarity principle. With the Lisbon Treaty, any chamber of a national parliament may submit a reasoned opinion to the EU institutions within eight weeks of presentation of a text outlining why they consider that it does not respect subsidiarity. The parliaments of Austria and Luxembourg have done so.

For Vienna, the text oversteps the framework of the internal market legal basis (Article 114) since it interferes with states’ right to organise their social security system. Austrian MPs base their arguments on Court of Justice case law stating that EU influence on national social security systems must be limited to a minimum.

Luxembourg’s parliament has concerns about an excessive increase in the administrative burden due to the shorter time limits and numerous new obligations. For its members, the proposal establishes “a blatant imbalance between obligations on member states and those on the pharmaceutical industry”. The chamber concludes that the text infringes the subsidiarity principle and unilaterally gives precedence to the pharmaceutical industry’s interests.

“NOT EASY” FOR COUNCIL

In keeping with the protocol on application of the subsidiarity and proportionality principles, the institutions must “take account” of the reasoned opinions submitted to them. An informed source notes that, in the light of these two warnings, the Council is going to have to be particularly “cautious” when examining the text.

The Council’s working group has already reviewed this issue twice, on 30 April and 31 May. According to an EU official, “it is too soon to give an opinion on the content of the proposal, but we can already say that this issue will not be easy”.

In the European Parliament, Antonyia Parvanova (ALDE, Bulgaria) has to finalise her report for the start of July so that there can be an exchange of views with members of the Committee on the Environment and Public Health (ENVI) towards mid-September.