A substantial number of amendments were adopted as demonstrated in the report published on 25 January [1].

A couple of people expressed concerns about the adoption of the proposal since a considerable rewriting of the articles was suggested. Some MEPs believe that the proposal on transparency on medicine pricing may never be adopted. However Antonyia Parvanova MEP (Bulgaria, S&D), the Rapporteur, already confirmed her determination to move forward with the adoption of the proposal.

- Background information

The European Commission published a new proposal for a Directive which should repeal the so-called “Transparency Directive” (Directive 89/105/EEC), adopted at the end of the 1980s. The main aim of the latest proposal is to safeguard public health by ensuring that the quality, safety and efficacy of medicines are properly evaluated before they are made available to patients in the European Union.

Two major reasons have fuelled the need to update the existing legislation. Firstly, theemergence of generic medicines: Generics can provide cheaper versions of existing products, as well as more transparency concerning prices. Secondly, the constant rise in public expenditure on pharmaceuticals over the last few decades has encouraged member states to devise more complex and innovative pricing and reimbursement systems. These and related developments created a proportionate need for more transparency during the whole process. Basic procedural obligations should be met to ensure that pricing and reimbursement measures are compatible with Single Market rules and that they do no create barriers to trade. In addition, the European Commission stated that deadlines for pricing and reimbursement decisions are regularly exceeded by member states [2].

The new proposal considers a few changes while taking into account the provisions of Directive 89/105/EEC. The shorter time limits for pricing and reimbursement is the most important measure for public health and patient safety since delays can have potentially negative impact for patients, pharmaceutical companies, member states and healthcare systems. For generic medicines time limits have been reduced to 15/30 days when the reference product has already been priced and included in the health insurance system. The time limits applicable to all other medicinal products have been reduced to 60/120 days. The reduction for originator medicines is from the current 90/180 days to 60/120 days.

- EPHA Position

All patients are entitled to have timely access to high quality, efficient, safe, essential medicines. No patient should be prohibited from accessing such medicines due to costs. Hence EPHA calls for Member States’ compliance to ensure timely pricing and reimbursement decisions. Patients should not be in a position where they cannot access medicines they need because of governmental inaction.

Generic products have already demonstrated their potential for generating cost savings for both health systems and patients, they are now widely recognised, and their use is steadily increasing in Member States with proactive generic substitution policies. From a public health standpoint it is essential that they reach patients without due delay.

- Next steps:

Currently the procedure is awaiting the first reading at the European Parliament.

  • During 2013 it is expected that agreement can be found on the final text by the Council and European Parliament.

EPHA related articles:


[1] REPORT on the proposal for a directive relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems. 24.01.2013

[2] Faster access of patients to new medicines - Revised Transparency Directive. MEMO/12/148, 1 March 2012

Last modified on February 4 2013.