Recent high-profile public health concerns have resulted in a push for more aggressive and proactive regulation in many sectors. But should this be at the expense of many of the procedural safeguards that most companies and individuals have enjoyed historically?

In the pharmaceutical sector, a raft of recent laws and guidelines have enhanced regulators' ability to monitor the safety of medicines and to take necessary action. Most of these changes are clearly steps forward. Regulators and manufacturers must now manage risks proactively. All applications for marketing authorisation must include a risk management plan that identifies and quantifies risks and proposes steps to manage them. Monitoring of product safety has also evolved from a formulaic review and submission of adverse event reports into a more holistic assessment of a product's safety and its evolving risk-benefit profile.

Most people agree that effective drug safety regulation should also allow timely and effective action to address safety concerns. Both regulators and manufacturers must be able to amend information for physicians or patients, either by including additional warnings or restricting the use of products in certain groups of patient. Where necessary, they should be able to suspend or revoke marketing authorisations.

Until late 2005, regulators wishing to suspend or revoke a marketing authorisation could do so where a "product proves to be harmful in the normal conditions of use, or where its therapeutic efficacy is lacking". Pharmaceutical legislation and regulators now advocate a more precautionary approach, envisaging action where they identify a risk, even if they are unable to determine whether the risk is real, or to quantify it. They can now act to suspend, revoke, withdraw or amend an authorisation "if the view is taken that the product is harmful under normal conditions of use, or that it lacks therapeutic efficacy". There are also powers to suspend, revoke or amend an authorisation if, following an evaluation of safety data, an authority considers that such action is required. These are entirely subjective standards requiring no proof that a risk is either real or significant enough to justify action.

An increased adversity to risk and the lowering of the evidentiary burden for regulatory action is not necessarily unwelcome, but this has gone hand in hand with a watering-down of a number of procedural protections. Regulators are now prepared to take action against products on the basis of little or no evidence and without having given manufacturers any meaningful opportunity to be heard.

Increasingly, medicines are regulated centrally by European Community bodies. Safety issues with products available in more than one member state are almost invariably raised to the Community level, either for a binding European Commission (EC) decision or for debate within the European Medicines Agency (EMEA), its committees or working parties. Once there, manufacturers can lose many of the procedural rights available at the national level.

That is not to say that Community level procedures offer manufacturers no rights. Manufacturers often have rights to make submissions and to appeal against unfavourable decisions or opinions. However, appeal is invariably to the entity that adopted the original decision or opinion, often with limited scope to submit additional evidence.

Of greater concern, however, is an increasing tendency to make use of informal procedures, which give manufacturers neither the right to make representations or any rights of appeal. For example, some procedures operated by the Pharmacovigilance Working Party of the Committee for Medicinal Products for Human Use are examples. The group routinely considers product safety issues with a view to reaching a consensus among the member states. The outcome of their discussions is often presented to companies as a fait accompli, without the manufacturer having any opportunity to address the group, make written submissions, or to appeal a decision.

Regulators should also be able to impose effective and dissuasive penalties on companies that fail to fulfil their obligations. The European Community Penalties Regulation which came into force earlier this summer allows the EC to impose significant penalties of up to 5% of annual Community group turnover if a company infringes pharmaceutical rules. Despite their size, fines are imposed without many of the protections common at the national level. All that is required is an EMEA investigation and an EC decision. While companies have an opportunity to make representations, procedural safeguards and the burden of proof are modest.

No pharmaceutical manufacturer wants to market an unsafe medicine, and nobody would argue that the commercial wellbeing of a company prevails over public health. There are clearly circumstances where regulators must act quickly and risks that justify precautionary measures. A lower tolerance of risk and the desire for more proactive regulation should not, however, be at the expense of procedural rights and a meaningful assessments of all the available data and perspectives.

Grant Castle is a partner in the European life sciences practice of Covington & Burling.