Article Text

Round up of EU Monitor news
  1. Richard Price
  1. Correspondence to Dr Richard Price, EAHP, 3 Rue Abbe Cuypers, Brussels 1040, Belgium; po{at}

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The EAHP produces a weekly email of the top European policy developments and other news of interest to Hospital Pharmacists called the EU Monitor. Below, EAHP Policy and Advocacy Officer Richard Price presents some recent highlights.

EAHP EU Monitor 12 October 2012

Responsible use of medicines can save $500bn a year globally

A report published by the IMS Institute for Healthcare Informatics in October 2012 suggests half a trillion dollars a year in global health spending can be saved by more responsible use of medicines through aligning capabilities, resources and activities more strongly.

The IMS Institute report highlights six specific levers of opportunity to improve the use of medicines, namely:

  • Increasing patient adherence

  • Ensuring timely medicine use

  • Optimising antibiotic use

  • Preventing medication errors

  • Using low-cost generics where available

  • Managing polypharmacy.

The report considers that improvements in patient adherence make up more than half—$269 billion—of the $500 billion annual opportunity.

The report includes five recommendations for health ministers and other health system leaders to implement in order to drive improvements. These are:

  • Support a greater role for pharmacists in medicines management

  • Invest in medical audits that focus on elderly patients

  • Implement mandatory reporting of antibiotic use

  • Encourage a ‘no blame’ culture towards error reporting

  • Support targeted disease management programmes for prevalent non-communicable diseases.

Commissioner Dalli gives views on how the health sector can meet the austerity challenge

Speaking at the European Health Forum in Gastein in October, the European Commissioner for Health, John Dalli, set out his views on the need for innovation and efficiency in health systems across Europe in order to effectively meet the austerity challenge.

His suggested solutions for the health sector in meeting growing need in a time of constraint in public finance included:

  • Focusing on cutting known inefficiencies

  • European and cross-border cooperation in health to achieve larger economies of scale and greater sustainability

  • Implementing electronic patient records and prescription systems

  • Increased Health Technology Assessment cooperation between countries

  • Using EU Structural Funds to assist certain health purposes including:

    • investments in eHealth and health technology

    • supporting health education and prevention campaigns

    • training health professionals.

His speech also called for Governments to recognise the role that good health systems can play as a key economic contributor and an asset to workforce productivity.

EAHP EU Monitor 19 October 2012

John Dalli resigns as EU Health Commissioner

John Dalli has resigned as the European Union's Commissioner for Health. His resignation came following an investigation by OLAF, the EU's anti-fraud office. OLAF investigated a complaint made in May by Swedish Match, a tobacco firm. The company alleged that a Maltese entrepreneur had tried to affect legislation, particularly relating to the EU's ban on the export of snus, a smoke-free tobacco used widely in Sweden.

Although the OLAF report did not find any conclusive evidence of the direct participation of Mr Dalli in the matter, it did consider that he was aware of the events. Following the report, Mr Dalli decided to resign ‘in order to be able to defend his reputation and that of the Commission.’

EAHP EU Monitor 5 November 2012

European pharmacovigilance review of diclofenac-containing medicines launched

The European Medicines Agency (EMA) has announced it is commencing a review of diclofenac-containing medicines to assess their cardiovascular safety.

Diclofenac is a widely used non-selective non-steroidal anti-inflammatory drug (NSAID), a type of medicine used to relieve pain and inflammation. A recent review of scientific studies by the Agency's Committee for Medicinal Products for Human Use assessed the latest data on the risk of cardiovascular side effects (such as heart attack or stroke) with non-selective NSAIDs. It concluded that the latest available data provide further evidence on the known risk with these medicines. Overall, the studies consistently indicate a small increase in risk with diclofenac compared with other non-selective NSAIDs, similar to the risks of COX-2 inhibitors (another class of painkillers). The review will cover diclofenac-containing medicines formulated for systemic use (such as those taken by mouth or injection). The EMA will evaluate the impact of the latest information on the benefit/risk balance of diclofenac and consider the need to update the existing treatment advice with regard to cardiovascular risk.

The review of diclofenac has been initiated at the request of the UK Medicines Agency under Article 31 of Directive 2001/83/EC. The review is being carried out by the Pharmacovigilance Risk Assessment Committee, the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.

Pharma industry make proposals to resolve medicines supply threat in Greece

EFPIA, the principal trade association for pharmaceutical companies in Europe, has made a proposal to cap the total amount the government of Greece pays for its medicines in a bid to resolve a crisis that is jeopardising the supply of drugs to hospitals and patients.

According to reports from Reuters news agency, EFPIA has suggested that, in exchange for a ceiling on outpatient pharmaceutical expenditure of 2.88bn Euros in 2012, the government in Greece should then commit to pay all outstanding debts and prevent further arrears from building up.

The move follows growing concerns about the situation in Greece, where the government last month took the highly unusual step of suspending all drug exports from the country in an attempt to prevent shortages.

EAHP EU Monitor 12 November 2012

Action Plan launched to create new tools for patient adherence

A new European Action Plan has been launched to help develop innovative new technologies and processes to improve patient adherence to medication. The plan is part of the European Innovation Partnership (EIP) on Active and Healthy Ageing, a European Commission-supported initiative to bring together stakeholders to address societal challenges.

Focusing on the fact that the number of people aged over 65 in Europe will almost double over the next 50 years from 85 million in 2008 to 151 million in 2060, the plan looks for new approaches and innovation in the delivery of this aspect of health care. Noting as well that adherence to long-term therapy for certain chronic illnesses in developed countries averages only 50%, the plan tries to identify innovative organisational, technical and medical practices to achieve better adherence.

Over 40 stakeholder organisations have so far come forward to contribute to the EIP's Action Plan, including regional health departments, universities, national medicines agencies and pharmaceutical and device companies.

Some of the concepts to be taken forward by the Action Plan include developing new:

  • early warning systems for poor adherence to medicines

  • ways to use mobile devices to facilitate adherence to medicines

  • prototype web applications for diabetes medicines management

  • IT packages to promote real time information exchange between patients, GPs and pharmacists

  • device sensors which can monitor complex drug compliance

  • software programmes to help 65+ diabetic and multi-morbidity patients

  • uses of social network tools to monitor adherence

  • ICT-based programmes for remote monitoring of health status and adherence to medical plans.

The Action Plan also envisages the participating stakeholders collaborating to produce new patient empowerment tools, including web-based training programmes.

Individually active partners in the Plan include the Italian Medicines Agency, NHS Scotland, the Hospital de Getafe (Spain), the Hospital Clínico San Carlos (Madrid), the Department of Health and Consumer Affairs of the Basque Government and the University of Coimbra Hospital (Portugal).

EAHP EU Monitor 27 November 2012

Tonio Borg approved by European Parliament as new Health Commissioner

Tonio Borg, Malta's candidate to replace the previous European Commissioner for Health John Dalli, has been approved by Members of the European Parliament with 386 votes in favour, 281 against and 28 abstentions.

Mr Borg's approval should now be finalised by the Council of Ministers in the coming days. He will then be able to take up his post as Commissioner for Health and Consumer Affairs.

His election was not without controversy, however, with some political groups of the European Parliament withholding their support on the basis of his previous expressed personal views on issues such as gender equality and the rights of women and homosexuals.

EMA publishes plan on medicines shortages

Responding to the growing and European-wide problem of medicines shortages, the EMA has published a plan to help the European medicines regulatory network cooperate in resolving some of the causal factors involved.

The paper, published by the EMA on 26th November:

  • summarises the lessons the EMA has learned from previous crises where it played a supporting or coordinating role

  • provides a short and medium-term plan to help the European medicines regulatory network prevent, mitigate and manage shortages of important medicines

  • identifies the globalisation of manufacturing and supply chains as a major contributing factor to the occurrence of supply shortages.

The paper acknowledges that, while control and supervision of the national pharmaceutical markets remain a national responsibility, Member States may experience difficulties in acting in a purely national way when faced with a pan-European crisis. The EMA therefore considers it has a role in coordinating the development and communication of appropriate risk management measures arising from unexpected shortages in supply.

Some of the public safety concerns identified by the EMA in relation to medicines shortages include (1) defective medicines being left on the market to prevent shortages of life-saving medicines and (2) the restricted ability of regulators to ensure GMP compliance at a production site due to the impact such measures could have in exacerbating shortage problems.

Among the causal factors identified by the EMA in the paper are (1) globalisation of manufacture extending supply chains which increases the risk of supply disruption and (2) the location of manufacturing centres in areas ‘that have uncertain political and regulatory systems and which may be prone to natural disaster’.

The paper criticises industry risk management in relation to shortages as being too reactive rather than proactive, and also considers that more discussion is required about the risks involved when monopolies in supply of medicines exist.

Accompanying the EMA paper is a list of short- and medium-term actions the EMA intend to take forward through its own secretariat and its national regulatory partners. These include:

  • Establishing an internal catalogue of Centrally Authorised Products (CAPs) and non-CAPs requiring coordination at EU level (eg, referrals) that have experienced product shortages to facilitate future analysis of trends and communication on shortages

  • Maintaining a public catalogue of current shortages of CAPs and medicinal products where an EU coordination of assessment has been undertaken

  • Developing a common understanding of the concept of ‘essential’ medicine and developing a decision tree to assist decision-making on what shortages should be addressed at the EU level

  • Establishing and publishing a Standard Operating Procedure for handling reports of shortages in supply of medicinal products due to quality defects and manufacturing problems

  • Exploring if ‘crisis’ situations arising from product supply shortages can in the future also be addressed in the context of the EU Regulatory Network Incident Management Plan.

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  • Competing interests None.

  • Provenance and peer review Not commissioned; internally peer reviewed.

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