A sweet harmony

Concerns over safety could see patients demanding harmonisation in healthcare

The European Union (EU) plays a schizophrenic role when it comes to health, with the provision of health services remaining the exclusive territory of Member States.

Each state has a minister, a government department and individual provision frameworks that vary enormously. The UK and Sweden tend towards a social model of health, based on the use of taxation in various forms. Most states have a mixed economy, based on elements of tax linked to social or private insurance. Recent EU joiners, such as Poland and Hungary, are increasingly encouraging private provision and private insurers, with a limited safety net for the poorest people.

Member States guard control of their health systems fiercely and resist any attempt by the EU to interfere in their internal affairs. The EU, through the European Commission, is edging slowly towards some commonality in health policy, but this is being met with resistance or treated with a degree of hostility by many Member States.

The EU has a Commissioner for Health and Consumer Protection, Markos Kyprianou, who has a staff of around 800 people in his directorate, based in Brussels, Luxembourg and Strasbourg.

He has a number of key agenda issues relating to EU public health, including patient mobility, EU-wide health indicators, common data collection for major illnesses, smoking, drug misuse, alcohol use and nutrition. This allows the Commission to roam freely across the health sector under the public health banner.

The Commission also has a role in common responses to health threats. The current scare over bird flu provides a good example where EU co-ordination in response to a health threat is considered desirable. Following the BSE in beef crisis, an EU-wide approach was also attempted.

When it suits Member States to have a common response to a cross-border public health threat, they will accept this, but only to a limited degree.

The EU issued guidance on the vaccination of chickens and other poultry for bird flu, but there is ample evidence that each Member State has either ignored the EU or adapted the guidance to suit their own local circumstances.

In the short term, it is clear that power in health provision and policy is likely to remain in Member States, but what about the medium and long term?

The region spawns many EU-wide institutions and organisations in the health sector, including the European Hospitals Federation, European Health Management Association, WHO Europe and the European Social and Health Quality Association, a network of service users in mental health and many other quangos and non-governmental organisations.

Whether Member States like it or not, these agencies are increasingly interested in common standards and practices across the EU in the health sector.

Some recent examples of pan-European thinking are interesting in that they seek to challenge the supremacy of Member States. In January 2005, the EU and WHO Europe held a ministerial conference in Helsinki, looking at some common objectives in mental health. Ministers from all EU states and some accession countries, (eg, Bulgaria and Romania), met with experts and user representatives to agree a set of principles to guide policy making in mental health across Europe.

Common ground
Remarkably, there was consensus on this topic and WHO Europe is now actively seeking to ensure this guidance is used in the planning and provision of mental health services across Europe.

The guidance is full of lofty statements and grand ideas, but many professionals are glad these principles have been agreed and will use the Helsinki agreement to lobby hard for better standards.

In Berlin in May 2005, Johnson & Johnson (J&J) held a conference, bringing together patient groups from across Europe to build dialogue between these groups and pharma, and to discuss working ethically.

Patient groups of all kinds were there, including diabetic patients, cancer groups and users of mental health services.

Interestingly, all groups, regardless of their country of origin, felt the same issues were important.

These included the need for openness and transparency in relationships, the importance of preventing undue pressure to promote a particular drug or product, and the need for clear and agreed objectives between partners.

J&J facilitated this network and it seems likely that it will build on this pan-European agenda for patient groups.

As I write, the Commission for Health and Consumer Protection is inviting proposals from interested bodies to test ideas around common experiences of people with mental health needs. In addition, the European Social and Health Quality Association is putting together a network of people to work together on this agenda, with a major event in Greece in June of this year to move this forward.

It is clear from these activities that there are many individuals and agencies that are keen to work with the EU Commission to bring about greater harmonisation of health standards across Europe.

Why should such approaches matter and are they likely to work?
Clinical practice across Europe varies greatly. Psychiatric diagnosis and treatment decisions also differ widely across the EU. In the Czech Republic, caged beds and mechanical restraint in psychiatric hospitals are still used and defended by doctors and officials.

In France, doctors are far more likely to prescribe drugs than in many parts of Europe. So it is a myth to suggest there is any such thing as a common EU standard in many areas of clinical practice.

In the UK, the National Institute for Health and Clinical Excellence (NICE) has been tasked with bringing about the use of best evidence-based clinical practice for England and Wales. In Scotland, the Scottish Intercollegiate Standards Group (SIGN) is attempting to do a similar job.

NICE and SIGN are hoping to share their experiences, but retain their separate identities. It is reasonable to imagine that the population of the UK ought to be able to agree common ideas around best practice for the whole population, yet the two bodies continue to do this differently.

If the UK cannot agree a common agenda, it is hard to see how we will get agreement across the whole of the EU.

Is the EU likely to try and copy NICE and SIGN at a European level? The answer in the short-term is definitely not. Member States will resist such harmonisation vehemently and health professionals would object strongly to this approach.

Safety concerns
Patient safety and the free movement of people across an expanding EU are more likely to impact upon standards of health.

In the UK, it is clear that many patients are killed, or seriously injured, by avoidable errors in hospitals. In response the UK government established the National Patient Safety Agency (NPSA), which is responsible for ensuring common reporting of errors and critical incidents, spotting trends and ensuring that lessons are learnt when things go wrong.

An example of NPSA work involves the incorrect addition of potassium chloride to intravenous infusions. Potassium chloride in the venous system can be lethal; sodium chloride, however, is essential to maintain electrolyte balance. Both are clear fluids and packed in similar glass ampoules. Regrettably, many patients died because hard-pressed doctors and nurses added potassium chloride by mistake.

The NPSA has instructed that no ampoules of potassium chloride be kept in any hospital ward drug cabinet. As a result, deaths from this simple human error have been virtually eradicated in the UK.

Issues relating to the safety of patients are of international interest. In the US, where litigation by patients harmed by error is high, a far greater focus on patient safety through the avoidance of error is in evidence. This is regularly debated in the American media and among physicians in a far more open manner.

The NPSA is currently engaged in active discussions with European health systems and other countries across the world and this agenda is likely to be of interest to patients, the public and politicians. If people in Member States and their representatives realise that their hospitals are less safe than those in other parts of Europe questions will be asked, and rightly so.

With greater movement of people within the EU, access to healthcare for EU citizens is important. At the moment, there is little I can do, as a patient, to establish if the treatment I receive across the EU is similar to that which I might expect at home.

As greater economic migration becomes a necessity in Europe, more people will want to be assured of the safety of care that they will receive. Member States will be pressurised by voters to ensure that they all offer reasonable levels of safety. As the drive for better standards gathers momentum, a degree of transparency around this issue will emerge because public opinion will force it up the agenda.

The Commission, with a responsibility for health and consumer protection, is interested in this area of health and far more likely to get agreement to harmonise safety standards in health systems.

For the pharma sector, it is unlikely that we will see the development of an EU equivalent to NICE, determining what may, or may not, be prescribed. We are far more likely to see something like an EU equivalent of the NPSA, which would be of importance to the industry. No drug is risk-free, and many can be dangerous if used improperly or in a negligent manner.

As the safety agenda moves forward, issues around the safety of product use, labelling and packaging are all issues that will be of interest to EU legislators. The growth of the patient voice across Europe, linked to the safety agenda, is also likely to increase in volume and influence.

Firms expecting common formularies and a NICE-style approach are likely to be disappointed. It is the safety agenda and the common experiences of patients across Europe that will matter.

Smart companies need to scan the EU policy agenda to track where the safety angle may take us over the next five years, for it is here that we will see greater pressure for harmonisation.

The author
Ray Rowden is an associate at the Healthcare Commission and a director of Mental Health International Development