Imagine you or a loved one have a disease. It can be treated, but only with a new medicine that is not yet available. The time it normally takes for a new drug to reach the market means it might be too late. But what if a fast-track approval made your medicine available sooner than is currently the case?

DoctorThat is the idea behind ‘adaptive pathways’, a pilot project launched in 2014 by the European Medicines Agency (EMA) [1] which is trying to speed up the approval of some new medicines that are urgently needed.

At first sight this scheme sounds like a life-saver. In theory, it would guarantee that consumers have timely access to innovative treatments, one of the things BEUC has repeatedly called for. But there is a lack of transparency as there has been no public debate to date. The EMA still has not published its report about how the project has been going so far. It was due in early 2016.

We need to look at why this particular process is worrying.

Faster approval would mean less research into how safe a drug is before it is approved. The fast-tracked drugs would undergo less safety and efficacy tests than usual before it enters the market. Such drugs would initially be available only to a small group of affected patients and would be gradually expanded. As some of the safety data would only be available afterwards, this means that consumers would be more likely to use unsafe drugs. And the last thing we want is that poorly tested medicines easily reach pharmacy shelves.

The data about the drug would be less reliable. To decide whether a fast-track-approved drug would be made available to more patients, regulators would rely on ‘patient’s registries’. They contain additional safety data about how the drug is performing among the small group of affected patients. The problem is those registries do not work as they should. They are only in place in some Member States and they are not always used, but are still costly.

More regular drugs could be fast tracked. The idea behind the project was to cover only those medicines where no treatment was previously possible. But this objective is a bit vague. If this fast-track approval procedure is meant to serve only the drugs that are urgently needed, the EMA should clarify this scope. Otherwise drug makers could start requesting hasty approvals for other drugs and expose consumers to unnecessary risks.

So what is the plus side?

Backers of this scheme say it will mean lower price tags. This sounds positive at a time when drug prices are going through the roof. But so far there is no proof that ‘faster approval’ means ‘cheaper drugs’. Backers even admit that setting prices for medicines that have been fast-tracked will not be easy because of insufficient data on the medicines’ safety and efficacy.Medicines

The question is: do we really need ‘adaptive pathways’? What is the project’s added value when fast-track approval already exists in exceptional cases? When a patient’s condition is critical, EU drug laws already contain provisions to help patients get early access to a new medicine that might help.

Could this be deregulation in disguise? Less rigorous pre-market approval procedures would make things easier for the drugs industry. But it would heighten the risk for consumers. Any move to relax existing rules at the expense of the patient’s safety is unacceptable.

Consumers tend to overestimate the benefits of medicines and understate their potential harm. Of course when you, or a loved one, have a serious disease you will be willing to try any possible cure. But what if it caused more harm than good?

In light of all these shortcomings and uncertainties, it is crucial for the EMA to ensure that early access initiatives, including ‘adaptive pathways’, are the exception, not the rule.

For more information, see BEUC’s position on ‘Adaptive Pathways’.

[1] The EMA is the EU body responsible for assessing the safety of medicines before and after they reach the market.

Posted by Francesca Cattarin

One Comment

  1. […] Read also BEUC’s blog “When drug approval is quick, it should not be dirty”. […]

Comments are closed.