Italian presidency must wrap up work on health dossiers

Medical devices regulation, genetic testing, antibiotic resistance and the increasing numbers of cancer patients are all issues which must be tackled at EU level, urges Peter Liese.

By Peter Liese

Peter Liese (DE, EPP) is Parliament’s rapporteur on the Revision of the EU Emissions Trading Systems (ETS)

01 Oct 2014

As of 1 July, Italy leads the rotating presidency in the European council. In the field of health policy in particular the current presidency can bring forward or even finish work on dossiers of high importance to patients and industry in Europe.

We see urgent pressure to act in the revision of EU regulation of medical devices. The scandal over defective breast implants produced by French company PiP and other incidents such as the market placement of false HIV tests have led to discussions about the safety of medical devices all over Europe.

In 2012, the European commission published two proposals on regulations for medical devices and in vitro medical diagnostics. My group, together with an overwhelming majority of the European parliament, supports the measures proposed by the commission in general, for example, not-announced controls at the manufacturer following market authorisation, traceability of medical devices and the introduction of a so-called implants passport.

However, we reject centralised authorisation as a general procedure for the marking authorisation for all medical devices. For diagnostics we aim for the introduction of minimum standards for genetic counselling and informed consent for genetic testing if these tests have serious effects on the patients’ future life. Genetic tests claiming to foresee the future are highly sensitive. They should not be done on public market places or on the internet, but only after qualified counselling through a medical doctor or other experienced experts.

"According to current incidence rates, every third male and every fourth female person in the EU will suffer from cancer before turning 75"

Both proposals of the commission have been on the table for about two years now and parliament’s position has been official since October 2013. In the interest of patients, and to give legal safety to industry, the council should finally find a common position to start trilogue negotiations and conclude the legislative procedure. We have to avoid further delay.
In the coming weeks and months one other important topic will find its way to the centre of political debate: resistances to antibiotics. These resistances can lead to a loss of effect of pharmaceuticals both for people and animals. In Europe, we talk about a serious growing problem. According to the world health organisation, 25,000 people in Europe die of resistant pathogens every year. Here, we must reach a decision on swift action if we do not want to lose the opportunity to treat human beings and animals with antibiotics.

There are experts already claiming a post-antibiotics era, with the main reason for this clearly being the mishandling of antibiotics in human medicine. However, we must not lose sight of the interdependence between animal and human resistance against antibiotics. The commission has recently proposed two dossiers taking up these issues which are now to be discussed between council and parliament.

Last but not least, the fight against cancer is a constant duty and is still becoming more important, especially for politicians dealing with health issues. The number of patients in Europe is increasing, and in particular one can observe growing numbers of so-called rare cancers. According to current incidence rates, every third male and every fourth female person in the EU will suffer from cancer before turning 75.

It will soon be the leading cause of death. Every year more than 1.5 million people die from cancer and 2.5 million people are diagnosed with cancer. These numbers cannot leave us calm. Society is ageing, and as such these numbers will continue to get bigger and bigger.

The EU can contribute to reducing the numbers of cancer patients through common research and informational campaigning. This is an issue we want to tackle together.

If the Italian presidency makes progress in these cases, we will be able to speak of a successful six months in the field of health policy.