MEPs adopt directive to give quicker access to generics

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

MEPs adopt directive to give quicker access to generics

Home/Policies & Legislation | Posted 15/02/2013 0 Post your comment

Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the parliament on 6 February 2013.

The draft law aims to give patients quicker access to cheaper generic medicines and will require authorities to meet new deadlines and transparency requirements on pricing and reimbursement of medicines.

‘It is unacceptable that delays in the pricing and reimbursement of medicines can sometimes reach more than 700 days. I am convinced that fair practices in our pharmaceutical market would also benefit patients and national healthcare systems,’ said Dr Antonyia Parvanova, a Bulgarian member of the ALDE group, who is steering the legislation through Parliament. Her report was adopted with 559 votes in favour, 54 against and 72 abstentions. She will now negotiate an agreement with EU ministers.

The draft Transparency Directive proposes:

a shorter price and reimbursement approval time-limit of 60 days for generic medicines
a ban on patent linkage, and
the separation of competences between pricing and reimbursement and marketing authorization authorities.

The proposals intend to give cheaper generics faster market access and according to MEPs the new pricing rules would cut medicine costs for both patients and health insurance schemes. Pricing and reimbursement decisions on new medicines will have to be taken within the current 180-day time limit.

The European Generic medicines Association (EGA) welcomed the adopted text, which it said is in line with the European Commission’s Pharmaceutical Sector Inquiry 1 that had identified the key hurdles that block or delay generic medicines entry to the market and thereby compromise competition, savings and access to treatment for patients.

Permission granted to reproduce for personal and educational use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: European Parliament