#Health: Patient safety is a pan-EU issue

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The European Parliament’s Committee on the Environment, Public Health and Food Safety is, among other matters, currently discussing two pieces of ongoing legislation on improving patient safety and requirements for registration of veterinary medicinal products, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.  

In the first instance, the Rapporteur Piernicola Pedicini MEP contends that a person’s right not to be harmed while being treated needs to be viewed as central to the needs of patients. Well, of course.

During the financial crisis, it became clear that patient safety was suffering under austerity measures (eg health service cuts) and recent figures suggest that from 8-12% of EU hospital patients - that’s in excess of 3 million citizens - suffered harm or even adverse events. These effects often include healthcare-associated infections, of which up to 30% are deemed preventable.

These views are fully endorsed by the Brussels-based EAPM, a multi-stakeholder organisation that is watching developments closely in this field. Health-service managers across the EU are, of course, aware of patient safety issues and such matters have inevitably been scrutinised extensively by not only the European Parliament but also the World Health Organization, the European Commission and European Council, and bodies such as the European Medicines Agency (EMA).

The rapporteur has concluded that among the main factors adding to patient risk (apart from the aforementioned cost cutting) are a lack of patient-safety measures at national level, difficulty in reporting adverse events, a lack of proper training for healthcare professionals, and overuse or misuse of antibiotics. There are other factors, of course.

Italian Pedicini, of the Europe of Freedom and Direct Democracy Group, believes that, rather than cuts, there needs to be “investment in continuing training, monitoring of medical and healthcare provision, alert systems, and preventive preparatory action if adverse events are largely to be averted, including those caused by the use of drugs”.  He has suggested that independent bodies should be made responsible for reporting adverse events and their potential causes.

On top of this, he says that such bodies should be tasked with determining forms of compensation for categories of patients harmed.  He also wants to see the presence of product specialists in treatment settings.  The Rapporteur also called for healthcare facilities to be managed by those people selected on the strength of their ability and merit, rather than by their political affiliation.

Meanwhile, on the subject of registration of veterinary medicines, Rapporteur Claudiu Ciprian Tănăsescu has called for a comprehensive assessment that will include the division of responsibilities between the EU and member states.  The Romanian MEP, part of the Group of the Progressive Alliance of Socialists and Democrats, says that this assessment should also establish the scope of the responsibility of the EMA. He has called for “a robust analysis of a clearly defined legal framework”.

To get a little technical, in late 2014 in the wake of an assessment of the internal market in this sector, the European Commission issued a proposal to bring together the rules on veterinary medicines under a single Regulation on veterinary medicinal products. This replaced an earlier Directive (2001/82/EC) while also amending a further Regulation.  A key reason was to remove references to veterinary medicines. This had the effect of decoupling provisions concerning veterinary medicines and those governing medicines for human beings.

In his position as rapporteur, Tănăsescu has written that he broadly endorses the proposal and welcomes the alignment to the Lisbon Treaty. The decoupling of marketing authorisations for veterinary and human medicinal products is welcome, he said.   The MEP has, however, also stated that the proposal could be improved, citing his disagreement with (among other matters) remuneration to national competent authorities being set by an implementing act.

Tănăsescu believes that the European Parliament should be “fully involved in the setting of agency fees” and mentions that this occurred in the pharmacovigilance legislation.  Amendments have therefore been suggested and the contents continue to be debated.  The influence and the importance of the Parliament’s involvement in such vital ongoing legislation is, according to EAPM, vital to maintaining stakeholder involvement in key areas of health and, while the Alliance notes that health care remains a Member State competence, involvement by EU institutions working on the basis of consensus and co-decision is to be welcomed.

The overarching aim of EAPM is to improve patient care by accelerating the development, delivery and uptake of personalised medicine and diagnostics, through consensus, and is a response to the need for wider understanding of priorities and a more integrated approach among distinct lay and professional stakeholders.  The Alliance has its own Interest Group of MEPs in the European Parliament and is engaged in significant, ongoing dialogue with relevant European Commission departments as well as the EMA.

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