EU Health Ministers have decided to take decisive steps to sort out the vaccines market after the experience of A/H1N1 influenza. They have agreed to explore voluntary joint procurement and expect that by doing so they will increase their negotiating position with the pharmaceutical industry. The only potential barriers to this are the EU competition rules, which are founded upon an open market for drugs. The power to regulate drug prices is a national, not an EU, power. Joint procurement for vaccines could open the door for a major programme of enforced and coordinated price reduction across the board which will be very tempting to countries whose health budgets are sorely stretched. However, a purchaser cartel might be as damaging as a provider cartel and will not necessarily see prices settle at the lowest level.
Ministers have also debated minimum vaccination coverage levels and the possibility of a common vaccination strategy that includes defining priority groups such as healthcare staff, police officers and firemen. Agreement will take some time given the divergence of current practices.
The Commission, meanwhile, has been focused on the health and well-being of the industry itself and has called on member states to take initiatives to promote the rational and responsible use of valuable innovative medicinal products as a means of improving treatment outcomes. Getting new drugs to market, no matter how good they are, is tough when health expenditure is being tightly constrained. They want pharmaceutical research to have a higher priority in order to increase the probability of innovative new products. They want a more effective clinical trials regime that will encourage the conduct of more trials in Europe. Only 11% of marketing authorisation applications submitted to the European Medicines Agency in the last five years were based on trials conducted in Europe. The EU directives that cover the pricing of medicinal products are now up for review.
Meanwhile John Dalli, the European Commissioner for Health and Consumer Affairs, has announced that he is willing to modify current proposals relating to the information given to patients when they receive prescription drugs. The incoming Hungarian Presidency has indicated willingness to deal with any new proposals as a matter of priority.
The EU wants a powerful research-led pharmaceutical industry but national health care systems want to control both costs and take-up. This tension point will not go away.
In the UK the new Coalition Government is consulting about a value-based pricing policy that creates a closer link between the prices the NHS pays and the value that a medicine delivers. This will undoubtedly challenge the industry but might have some long-term benefits with a more stable pricing system that might be able to recognise and reward innovation, in particular by encouraging a tighter focus on breakthrough drugs that address areas of significant unmet need. The system would provide a range of thresholds or maximum prices that reflects the different values that medicines offer. The hope, of course, is that this system will enable the industry to predict more clearly the potential return on research investment.
This level of heavy engagement between a government- and a science-based industry carries with it quite serious risks that innovation will be smothered. Blue sky innovation that discovers products that could never be identified in advance will become seriously risky. The Coalition are walking a fine line, which carries a significant risk to the long term future of a vital industry. The rest of Europe will be watching with great interest to see if the UK can get the balance right.