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What does the EU have to do with me?

The RPS representative on the Pharmaceutical Group of the European Union, Sid Dajani, takes a look at the areas of EU policy that can affect UK pharmacy practice

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The EU was originally conceived as a means to unite a fractious and warring Europe. Although it is easy to think that decisions made in Brussels are remote and irrelevant to our profession, there are many EU matters that can impact on the practice and business of pharmacy in the UK. Our profession will be increasingly driven by a pan-European agenda that seeks to harmonise services for European citizens.

Naturally we will need to pursue cooperation across Europe on initiatives affecting pharmaceutical science and the practice of pharmacy actively simply because the UK has wider interests that do not simply stop at the White Cliffs of Dover. Examples include the single market, foreign policy, defence policy, the environment, renewable energy and even climate change.

Alongside the recent financial crisis, there are important developments directly affecting pharmacy, such as tackling counterfeiting, drug trafficking, pandemics and other public health issues, medicines shortages and sharing research and best practices that will bring benefits our patients.

Some changes have already been implemented, such as abolishing the “threeyear rule”, which prevented EU-registered pharmacists from working in a UK pharmacy that had been open for under three years. Other changes are coming soon that will directly impact upon every pharmacist and pharmacy in the EU. So it is important you know what is happening, how you can be ready for the changes, how they may impact upon you, what you think about things, how you might influence them and how our profession could change.

Our mission as a rigorous, proactive and constructive stakeholder is to:

  • Establish co-operation in pharmacy among the European nations
  • Contribute and share resources to improve health systems, public health and services
  • Highlight threats to services, access and quality patient care at the earliest opportunity
  • Ensure pharmacy is reflected in EU policy and legislative developments
  • Through the Pharmaceutical Group of the

European Union, the Royal Pharmaceutical Society is engaging in more than 40 Directives, projects and issues at the EU level. These are described below.

Falsified medicines

It is estimated we already import around £2bn worth of medicines annually from the EU. Although most counterfeit medicines in Europe are acquired through illegal internet sources, the risk of a fake medicine entering our supply chain is a real one and accounts for around £20bn a year in Europe.

Incidents of counterfeit medicines entering the legitimate UK supply chain might be few, but the risks will increase as the EU and internet pharmacies continue to expand. The Falsified Medicine Directive, adopted in July 2011, aims to eliminate this risk through a “delegated act” to which the RPS is responding. What is agreed will be enshrined in UK law and adopted into practice by 2017. This will affect us all.

Cross-border healthcare

The number of cases where European citizens receive healthcare in a European member state other than their own is increasing. To ensure safe cross-border dispensing, in 2011 the PGEU adopted a statement on the necessary common elements of cross-border prescriptions, in line with the EU Directive on patients rights in cross-border healthcare. These elements include the specification of both international nonproprietary name and brand name of the prescribed medicine and the patient’s diagnosis. As with all EU matters, this is a complex and costly process, with many issues still remaining outstanding, including agreement on an EU-wide authentication system for the prescriber, a prescription template, patient verification, medicines availability and substitution.

Free movement of professionals

The EU Directive on free movement of professionals allows pharmacists to work more easily in different member states. The UK will potentially face a large influx of workers due to language being less of a barrier than in other EU states. PGEU discussions have been around harmonising education, introducing medicines management standards, looking at the concept of the European professional card or e-certificate from the home country, language testing and deciding what knowledge and skills pharmacists need.

The EU wants there to be fewer differences to exist between professionals, but we believe this may have the potential to lower professional expectations and standards rather than raise them.

Pharmacovigilance

Even after a medicine has undergone extensive clinical testing and received market authorisation, unexpected adverse drug reactions can come to light. Occasionally medicines are withdrawn. New pharmacovigilance legislation looks at the key elements of reporting potentially harmful effects of medicines and medical devices to the appropriate authorities. We have been discussing what the implementation of this legislation means for day-to-day pharmacy practice.

The RPS, through its involvement in the PGEU, is in a position to make the case that proposed changes must fit seamlessly with existing practice and that the intended advantages do not lead to unnecessary additional costs or workload. The EU has an ever growing influence on issues that affect pharmacies in the UK so it is right that we set out to the commission, MEPs and other stakeholders at the European level our aspirations for the profession.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.20065768

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