Transparency of pricing and reimbursement of medicines - a step towards a European Single Market

Zofija Mazej Kukovič MEP spoke during the plenary session in Strasbourg as the EPP Group's Shadow Rapporteur on "Transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems".

The proposal for the Directive establishes a simpler mechanism to facilitate the arrival of new products on national markets. Consequently, this means quicker accessibility of medicines, due to the shortening of procedures in which the competent authorities decide on the pricing and reimbursement procedures within the health insurance systems.

Mrs Mazej Kukovič stated in her introduction that the proposal for the Directive is an important step forward. The Directive has never been amended and does not reflect current realities in the sector. It also brings siginficant changes and faster accessibility of medicines for patients. Member States have different time limits when it comes to pricing and reimbursement. For this reason, the patients' safety can be endangered and consequences for industry are huge. This proposal is a step further to a single market."

The Report was accepted at first reading in plenary by a strong majority. Many Member States believe that the subsidiarity principle is endangered. The Parliament proposal intends to balance different approaches and wants to find a solution for Member States on one hand, and patients and the pharmaceutical industry on the other hand.

In her speech, Mazej Kukovič said: "The Commission has made a proposal which was in some way too ambitious for both Parliament and the Member States. After negotiations and complementarities, the proposal is balanced and offers a good starting point to move forward."

The representatives are responding to the concerns of the Member States by demanding less strict time limits than the European Commission. In the Council of Ministers, the proposal is presently blocked. The EPP Group Co-ordinator in the Environment, Public Health and Food Safety Committee of the European Parliament, Peter Liese MEP, hopes that the Parliament's vote will stimulate the deadlocked negotiations: "We have heard that the Commission will withdraw its proposal and prepare a new one following the moderate approach of the Parliament. This will finally bring about progress for the patients as well as for the innovative industries."

Pharmaceuticals are either licensed by the European Medicines Agency (EMEA) in London or by the responsible authorities of the Member States according to a European procedure. This makes sure that they are potent and the side effects are justifiable. However, afterwards, the Member States have, according to the principle of subsidiarity, the opportunity to decide on the price at which medicines are sold and if they are recompensed by the public health care system or the statutory health insurance.

Nevertheless, this decision has to correspond to certain rules since 1989 to grant a procedure which is transparent for all stakeholders and to assure that a binding decision is actually made. Unfortunately, practical experience shows that the Member States often do not adhere to the set time limits. It can take up to two years until a decision is rendered.

Peter Liese continued: "It often takes too long to get to a decision on pricing. This leads to the result that patients in some EU countries have no access to innovative pharmaceuticals, even though these can sometimes save lives. Moreover, this is a real obstacle, especially for innovative small and/or medium-sized companies."

Mazej Kukovič stated that patient safety should be our first concern. "As a former Health Minister, I am reminding you about the complexity and different time lines needed for medicines to enter the market. Time limits are too long, for both patients and for the industry."

Mazej Kukovič concluded: "Today is World Cancer Day, so we need to be especially aware of the importance of rapid and transparent access to medicines, especially of those medicines that save lives."