On the 17th February 2016, the European Parliament Committee on Environment, Public Health and Food Safety (ENVI) took the first step to change the way medicines are approved at European level, by voting in favour of the report and the amendments to the Regulation No 726/2004. This regulation is one of the key legal documents laying down how the European Medicines Agency (EMA) works and how new drugs are approved by EMA (click here to check all the legal sources on which EMA bases its work).

Background on the Draft Regulation

The Regulation 726/2004 gives the European Medicines Agency (EMA) responsibility for the centralised authorisation procedure for human and veterinary medicines in all EU/EEA countries. In 2015, the European Commission proposed to update the veterinary part, and to create a separate regulation for the veterinary products.

In the process, ECPC has strongly advocated the European Parliament to take this chance to update also the rules for human use products (medicines).

Several MEPs took this chance to propose a series of amendments to the Regulation 726/2004, which were collected within the report produced by MEP Claudiu Ciprian Tanasescu (Romania, S&D), responsible of this file within the ENVI Committee (so called “rapporteur”). Overall, the amendments proposed are expected to facilitate patients access to innovative drugs by reducing the time spent to decide the value and price of new medicines at country level.

In total, 53 amendments were tabled in the ENVI Committee, including the 16 amendments contained in the draft report (click here to check the full list of amendments and Tanasescu’s report).

In many EU countries the value of new drugs is decided on the base of how better the new drug is, in comparison to the drugs currently available (so called “relative effectiveness”) and on the financial resources a country has available. Relative effectiveness is calculated using the same data that the European Medicines Agency uses to check if a drug is safe, efficient and efficacious and therefore to allow it to enter the market (so called market authorisation). A harmonized European evaluation (as opposed to 28 evaluations, one per Member State) will help patients to have faster access to life-saving medicines. Moreover, having one single relative effectiveness evaluation would also cut duplications and inefficiencies at the national level.


The problem highlighted by ECPC

All EU countries are obliged to adopt and make available a new drug within 180 days from the moment the holder of a marketing authorization submits an application to the national authority to include a medicine in the national list. However, several studies show that in many countries the access to new, potentially lifesaving drugs is delayed. Today, each EU country has to assess the relative effectiveness on its own, independently, even if the data used to calculate it are the same for all EU countries. This helps to create significant differences in the time to access life-saving medicines across countries as the same drug is evaluated for its efficacy only once (at EU level), but 28 times for its clinical and economic impact.

A good example in this regard is transtuzumab, a drug which targets the ERB2 receptor and quickly became the new standard of care for this aggressive breast cancer. In April 2015, trastuzumab was included in the list of WHO essential drugs, which is a list of the medicines that every healthcare system in the world should make available to patients. Even if this medicine is so effective, there are great differences in time to approval/reimbursement across EU members (see figure below). For metastatic disease for example, variations within Western Europe were significant. While transtuzumab was immediately reimbursed to patients in Germany, the Netherlands and Spain, in the UK, the average delay was 564 days, in Belgium 1160 days and in Denmark 1891 days. Delays were even more pronounced in Eastern Europe: Hungarian patients had to wait 2713 days, Romanians 2878 days, Slovakians 3686 days and Latvians 4660 days before having access to this essential breast cancer drug.

Our readers should keep in mind that the EU Directive on drug pricing and reimbursement specifies a 180-day limit for the application holder of a marketing authorization to include a medicine in the national list. Obviously, adherence with this deadline is extremely variable and these significant delays lead to unacceptable loss of lives and dramatic reductions in breast cancer survival in many countries compared to the rest of Europe.


ECPC: accelerating access to life-saving medicines

Some ENVI Committee Members, in particular Elisabetta Gardini MEP (EPP, IT), Alberto Cirio (EPP, Italy) and Mathias Groote (S&D, Germany), have been instrumental to propose changes to this Regulation in line with ECPC policy position. The adopted amendments would require the Commission to establish a European relative effectiveness evaluation, valid for all EU/EEA countries.

The Commissioner for Health and Food Safety, Dr Vytenis Andriukaitis, who will be responsible to implement the new 726/2004 once adopted, has already shown his support for the creation of a single European relative effectiveness evaluation, demonstrating that the highest political level of the Commission is also in line with the demand of cancer patients (click here to read Andriukaitis’ speech from the European Health Forum Gastein 2015).

What’s next?

The draft report, complete with the approved amendments is expected to be voted by the European Parliament during its Plenary sitting in Strasbourg in Spring 2016. Once the final document is adopted by the European Parliament, Ministers of Health will analyse the text and provide their opinion on the changes introduced by the Parliament.

ECPC President Prof Francesco De Lorenzo declared that: “this is a great challenge to the status quo, a turnover for the future of many cancer patients. ECPC kept fighting this battle on behalf of its 383 member organisations knowing that we were translating the needs and rights of cancer patients into new norms. We have won the first round thanks to the collaboration with Ms Gardini and with a vast, cross-party support from the ENVI committee. This is the apex of a process that ECPC started more than one year ago, which shows our resilience and the solidity of our partnership with the European Parliament”.

Support from our members and media

 Il Parlamento Europeo si impegna a facilitare l’accesso alle medicine innovative salvavita – FAVO

Quotidiano Sanita’

Associazione Italiana di Oncologia Medica