Safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance

The European Parliament adopted by 637 votes to 32 with 10 abstentions a resolution on safer healthcare in Europe: improving patient safety and fighting antimicrobial resistance.

It recalled that globally, 10 million people would die every year because of antimicrobial resistance by 2050, and that resistance to antibiotics that were commonly used to treat causative bacteria was at least 25 % or more in several Member States.

Ensuring patient safety during economic crisis: Parliament called on Member States to make sure, in this period of economic crisis, that patient safety was not affected by austerity measures and that healthcare systems remained adequately funded. Member States were further asked to avoid short-term savings, which would lead to high costs in the medium to long term and to ensure that there were a sufficient number of healthcare professionals specialised in infection prevention and control, as well as hospital hygiene, with a view to a more patient-centred approach. Amongst other things, the resolution called on Member States to set specific and ambitious quantitative targets for reducing the use of antibiotics.

At the same time, Parliament set out the state of play on the Council’s recommendations on patient safety and the Commission’s second implementation report on the matter (please see the summaries set out in procedure reference 2013/2022(INI)). Members feedback and proposals for improvements include the following:

• ensure that health managers were appointed on the basis of merit and not of political affiliation;
• ensure basic training of all healthcare personnel, even those who were not in direct contact with patients;
• ensure the appropriate and up-to-date training of doctors and other healthcare professionals, as well as the exchange of best practices;
• ensure the adoption of a multidisciplinary approach in medical treatments;
• lighten the burden on healthcare facilities by promoting care and medical treatment at home;
• ensure that medical professionals inform patients when a medicine was used off-label and provide patients with information on the potential risks in order to enable them to give informed consent;
• promote information campaigns for patients concerning the risks of adverse events in the healthcare system and concerning possible preventive measures, starting with basic hygiene measures, and launch awareness-raising campaigns;
• step up hygiene precautions, making greater use of hygiene specialists to monitor all aspects of health and hygiene relating to healthcare facilities, patients and relations between patients and outside ‘guests’;
• develop EU guidance for patients’ involvement in patient safety strategies.

With regard to the need to fight against antimicrobial resistance, Parliament considered research for new antimicrobial drugs to be of the utmost importance, and called on the Commission to use the European Fund for Strategic Investments to stimulate research by, supporting existing structures such as the Innovative Medicines Initiatives. It called for greater attention to be focused on the development of new antimicrobial agents aimed at new targets. With regard to sales of antibiotics, Parliament called on Member States and the Commission to start a reflection process to develop a new economic model, that de-linked the volume of sales from the reward paid for a new antibiotic, which would reflect the societal value of a new antibiotic and allow for sufficient return on investment for the company, while the purchaser would gain the right to use the product and have full control over volumes.

Parliament also proposed the following measures:

• remind physicians of the paramount importance of ensuring that the prescription of antibiotics for treatment was appropriate and responsible;
• ensure that, whenever possible, appropriate microbiological diagnosis was systematically performed before prescribing antibiotics;
• regulate the prescription of antibiotics for treatment;
• encourage the development of new revenue models whereby economic returns for companies were de-linked from prescribed volumes of antibiotics, and at the same time, while encouraging pharmaceutical innovation;
• regulate the sale and distribution of antibiotics;
• intensify infection control, in particular from a cross-border perspective, and especially by carefully monitoring potential carriage of multidrug-resistant bacteria;
• improve safety standards, especially for medical devices that are resistant to sterilisation (e.g. endoscopes);
• launch awareness campaigns targeting a wide audience
• increase public funding and create new academic positions to focus on exploring and validating new approaches for treating bacterial infections.
• make the records of hospitals and other healthcare facilities with regard to HAIs publicly available, so that patients can make informed choices;

Parliament also asked the Commission to reflect on the consequences of the increased mobility provided for in Directive 2011/24/EU with regard to the enhanced antimicrobial resistance that could result from patients travelling throughout Europe for treatment.

Parliament also made a series of recommendations regarding antibiotic use in veterinary medicine in general and in husbandry in particular, notably:

• introduce legal tools to restrict the use of antibiotics in animals if a significant risk to public health is identified;
• implement tougher controls to limit the use of antibiotics in veterinary medicine, by restricting the right to prescribe antibiotics to professionally qualified veterinarians and by decoupling the veterinarians’ right to both prescribe and sell antibiotics so as to eliminate all economic incentives;
• ensure that livestock farming and aquaculture focus on disease prevention through good hygiene, housing and animal husbandry and on strict biosecurity measures, rather than the prophylactic use of antibiotics.

The Plenary did not adopt the position of its competent committee which had urges consideration of the possibility of banning antibiotics in medicated feed in the upcoming discussions on veterinary medicine and medicated feed legislation.

On the other hand, Parliament agreed with its competent committee in calling on co-legislators, when negotiating the proposal for a regulation on veterinary medicinal products (2014/0257(COD)), to ensure that standards of quality, safety and efficacy of veterinary medicinal products were not lowered with the new legislation and to prohibit the on-line sale of antimicrobials. Parliament also called for research into the potential direct or indirect damage arising from by the use of antimicrobials in pets, and to develop mitigation measures to reduce the risk of potential transmission of antimicrobial resistance from pets to people.

It went on to make recommendations on collaborative approaches within the EU, calling on Member States to cooperate on defining minimum patient safety standards and indicators for safety and quality of healthcare at the EU level. The Commission and the Member States were asked to further engage in a dialogue with all stakeholders and develop a coordinated, comprehensive and sustainable EU strategy for patient safety. They were also asked to optimise EU partnerships between academia and the pharmaceutical industry, and Members encouraged pharmaceutical companies, governments and academia to contribute with their best assets (infrastructure, compounds, ideas and financial resources) to ground-breaking fundamental research.

The resolution asked the Commission to consider a legislative framework to encourage the development of new antibiotic drugs, for example in the form of an instrument governing antibiotics for human use similar to that already proposed for antibiotics for animal use.

It also encouraged the EU to promote and take part in any global initiative aimed at improving ways of combating antibiotic resistance, and to support research in this field.

Lastly, Parliament stressed that antimicrobial resistance had become a serious problem that needed to be urgently tackled. It called on the Commission to consider proposing legislation on the prudent use of antibiotics if little or no progress had been made in Member States within five years of the publication of these recommendations.