Brian Edwards CBE
Emeritus Professor of Healthcare Development
(European Hospital and Healthcare Federation)
The European Commission has long held the view that it should support a stronger pharmaceutical industry. A recent report on the competitiveness of the European-based industry(1) concluded that: “Europe is lagging behind [the USA] in its ability to generate, organise and sustain innovative processes that are increasingly expensive and organisationally complex.” There is a real tension between ministries who want to see the industry expand, employ more people and contribute more taxes and others, such as ministries of health, who want to control prices and influence the developmental pathways. One of the mechanisms used to take the discussions forward was a Pharmaceutical Forum to work around three key themes: information to patients on pharmaceuticals; pricing policy; and relative effectiveness assessment. All three are contentious issues. Information to patients is now recognised as one of the most crucial components of an effective patient safety strategy, although many would regard the need to sort out the problems of labelling and names as even more important. There are dozens of examples of drugs with similar names in lookalike packaging being administered incorrectly to patients every day in European clinical practice, sometimes with fatal results. The information sheet contained within most packs of prescribed drugs, with its long lists of potential side-effects, might almost be designed to reduce their consumption by patients rather than encourage compliance. It is high time they were written with patients in mind rather than by lawyers seeking to limit future liability. Plans to harmonise patient information on a European basis strike me as well intentioned but naive, as are ideas about a European patient advice line. Spreading good practice and ideas might be more productive.
The pricing of drugs must be one of the most discussed issues at meetings of health ministers. Pharmaceutical products now soak up 15–20% of most countries’ overall health investment. This might be very appropriate, but one suspects it is more a consequence of clever and sustained marketing. Routine medicines reviews with patients are now part of the new payment structure for pharmacists in the UK, but opinion is very divided about their relevance and impact on patients. The push by governments to increase the use of cheaper generic products has been very successful, and it has put real pressure on the traditional pharmaceutical industry. Some European countries still have a long way to go down this road. What is likely is the development of mechanisms for price comparison across Europe despite the difficulties of interpretation this will generate. A European-wide price agreement is most unlikely, but some agreed methodology for building in research and development costs might be possible.
Technology assessment (National Institute for Health and Clinical Excellence [NICE] in the UK) is expanding rapidly across Europe, and the various national centres are beginning to work together. They represent mixed blessings for the industry. A drug that gets through the assessment process is guaranteed sales in most countries, but the evaluation processes are slow. Drugs that do not pass the test struggle to generate sales that can justify their place in the market. There have been some bad examples recently of patients groups with the support of the industry challenging these technical assessments and occasionally winning over weak politicians. The idea of a EuroNICE pushes up the risk for the industry. However, whilst ever the evaluations contain a national economic component (which must be widely variable), the possibility of European-wide judgements is unlikely. A website containing details about national evaluation will be useful and would be even more powerful if the industry logged onto it their clinical trial results for access by both professionals and patients. Safeguarding the European supply chain to prevent counterfeighting is something that the Commission should take on. We have no reliable estimate of its scale, but some experts think it is significant and growing. There are areas where the EU must seek means of incentivising the industry to research areas where public health solutions are needed. The most pressing example is in the antibiotic field, but orphan diseases also represent a challenge. Many wish the industry would be more transparent about its marketing techniques. Voluntary codes of conduct do help, but when the penalty for a serious breach is a temporary suspension from membership for a few months rather than a fine one doubts whether it is enough.What is, however, clear is that European health systems have to rely heavily on the products generated by the industry. This places a premium on partnership rather than conflict. The forum should be encouraged to continue its work.
- European Commission. Public Health; Pharmaceutical Forum. 29/9/06.