After a Brexit: how much more difficult would the authorisation procedure for new drugs become?

Published on 29th Apr 2016

Although invisible to the end-consumers, harmonisation of the criteria and procedures for authorising new pharmaceuticals and agrichemicals to be put on the market has been one of the great success stories of the European Union.

Solving an age-old problem

Since the early years of the twentieth century, governments worldwide have played a gatekeeper role to ensure that medicines sold to patients in their territory are safe, effective and produced at a suitable quality. This regulatory regime replaced centuries of quack doctors and snake-oil salesmen preying on the fears of the ill or worried well, frequently with no effect at all but sometimes causing greater harm than the disease supposedly being treated, or even death.

But different regulators in different territories took different approaches and applied divergent standards, so that a medicine widely available over the counter in one country might be available only on prescription, or not at all, in another. Further, the time taken for approval could vary enormously so that patients in a country with limited regulatory resources could wait years after their cousins abroad had been able to obtain a particular medicine. Since health is one of the hottest political issues at all times and in all countries, regulators in general were extremely conservative in their approach.

The EU’s co-ordinated approach

It is not surprising, therefore, that the EU has implemented a co-ordinated approach to marketing authorisation, including intensive work to ensure national regulators apply closely similar principles when assessing quality, safety and efficacy.

New drugs can currently be authorised in the European Union through three separate routes:

  • a Centralised procedure;
  • a Decentralised procedure; and 
  • purely national systems. 

Centralised procedure

As its name suggests, the Centralised system permits a single application to be made centrally, through the European Medicines Agency (EMA) in London, which if granted entitles the manufacturer to put the drug on the market in all 28 Member States of the EU. The EMA provides scientific advice on the kinds of clinical studies which may be needed in order to demonstrate the product is suitable for marketing, using a network of around 4,500 scientists and clinical specialists all over the EU. It also monitors the safety of medicines after they have been placed on the market, through a pharmacovigilance network and a centralised database, EudraVigilance, so that it can take appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was authorised. This route is compulsory only for specified categories of drugs such as biotech products, AIDS, cancer, neurodegenerative and diabetes treatments. But manufacturers can also opt to use it for any other new drug substance, or a product which constitutes a significant therapeutic, scientific or technical innovation.

Decentralised procedure

The Decentralised procedure applies to any application for marketing authorisation for a drug not currently sold anywhere within the EU, where the manufacturer wants to sell it in more than one Member State. One Member State takes the lead, acting as Reference Member State, with the others essentially accepting its conclusions for the purpose of authorisation for their own countries.

Approval for all

These systems enormously improved the efficiency of bringing new drugs to market for European consumers, and account for the vast majority new drug approvals. Less-experienced or less well-resourced regulators can no longer insist on different information being provided, or hold up a process due to limited staff or other local problems. Patients may still receive different treatment based upon local prescribing cultures, and traditional remedies play a greater or less role according to local culture. But so far as the legal system can determine it, once a medicine is approved anywhere within the EU it is approved for all.

How long would the delays be?

If the UK withdraws from the EU, however, then unless the UK were to opt simply to rubber-stamp EU approvals, something unlikely to be politically acceptable, all new medicines will have to be individually approved by the UK’s regulators before being made available to UK patients. The question is not whether this would lead to delays, but how long the delays would be.

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* This article is current as of the date of its publication and does not necessarily reflect the present state of the law or relevant regulation.

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