The list of drugs that are subject to additional monitoring (black triangle drugs) will be expanded to include all drugs subject to some kind of post-authorisation safety study. The black symbol is intended to encourage the informed patient and healthcare professionals to look out for and report adverse reactions. The proposed changes to the regulation will also introduce an automatic emergency procedure if any Member State withdraws a medicine from the market or if a company withdrew a product on safety grounds. When companies voluntarily withdraw a drug or do not apply for a marketing license, they will be required to declare whether this was because of safety concerns.
The parliamentary interest in this field has its roots in the Mediator inquiry in France. Mediator was a licensed and widely prescribed diabetes drug but it had problematic side-effects. It was finally withdrawn from the market in 2009 but regulators had been discussing the problems associated with its active ingredient, benfluorex, over a period of years, going back as far as 1998. According to the parliamentary statement, there were many avoidable deaths.(1)
The impact of the European financial problems on the health sector is now beginning to emerge more clearly. In Greece, where the problems are most visible, the health budget has been cut sharply, mainly by reducing the salaries and benefits of staff and cuts in hospital operating costs. The rescue deal with the International Monetary Fund and the EU actually specified €2 billion savings from pharmaceutical products, thereby reducing expenditure on drugs to 1% of gross domestic product.
This is to be accompanied by a positive list of reimbursable medicines with a focus on generics. Doctors are now required to prescribe by active substance rather than brand. The maximum price for generic medicines cannot exceed 40% of their equivalent branded drugs; e-prescribing will become compulsory on 1 July 2012 in order to make the switch to generics easier.
The accelerated move to e-prescribing and generics is now part of many countries’ austerity programmes. Estonia has established a generic promotion campaign in association with family physicians. The Czech Republic has plans to introduce a simplified approval progress for generic drugs to enter the Czech market; Ireland has increased its prescription charges.
Representing, as it does, over 10% of health expenditure in most countries, the financial squeeze on drugs was inevitable, as was the desire of governments and insurers to move to cheaper generic drugs. The industry must, I think, plan for these changes to become permanent. The days of constant year-on-year growth in health expenditure have gone, perhaps for as long as a decade. We can expect some fierce battles about pricing controls in the coming months.
- European Parliament. Committee on the Environment, Public Health and Food Safety.11.05.2012. Report A7-0165/2012.