A number of media articles have claimed that “EU red tape” is denying cancer patients access to new treatments.
This is not the case.
Various EU initiatives, backed by billions of euros from the EU budget, encourage Europe’s top scientists, businesses large and small and leading medical professionals to get new drugs to patients as rapidly and safely as possible.
And Europe-wide authorisation by the European Medicines Agency means more people get access to more medicines more quickly than they could if each country authorised them separately.
Delivering new drugs to patients is a multi-stage process.
First, they need to be developed from scratch.
The European Commission has invested about €2.1 billion in cancer research projects since 2007. Some outstanding examples are described in simple terms here. The pace is likely to increase under the 2014-2020 Horizon 2020 programme, which is about 35% larger than its 2007-13 predecessor known as FP7.
€227m of that funding has gone to 180 projects focusing on breast cancer research. These encompass prevention, early diagnosis, resistance mechanisms, novel treatments and quality-of-life issues. Nearly a third of that money (€ 72m) has gone to 96 different UK universities, hospitals, SMEs and other organisations.
Two further projects are specifically linked to the use for other cancers of palbociclib, the anti-cancer medicine mentioned in recent media articles as an alleged victim of red tape.
There is a need to identify the most promising drug candidates with as much certainty as possible at the earliest stage possible. That is the aim of the EU’s Innovative Medicines Initiative, a €3.3bn public private partnership with the pharmaceutical and life sciences industries.
Clinical trials are necessary to investigate the effects of a drug in humans. The EU’s new Clinical Trials Regulation will enter into force this year. It will simplify current rules by having a streamlined application procedure and a single authorisation procedure for all clinical trials. The criticisms of EU clinical trials rules referred to in some of the recent media coverage relates to earlier legislation which will now be replaced by the new rules.
Once all the data are available, a new medicine needs to be authorised for general use with patients. In the EU centralised procedure, a scientific evaluation of a marketing authorisation application is performed by the European Medicines Agency (EMA), based in London.
Guido Rasi, the EMA’s Executive Director, said: “The protection of patients is the reason why we have a rigorous approval process in place before we allow a medicine onto the EU market, which serves more than 500 million citizens in 28 countries. Thorough analysis of a medicine’s benefits and of the harm it could do is clearly not red tape. We of course understand the urgency but we will not do incomplete assessments – in the best interest of patients.”
Such an authorisation, granted by the European Commission based on EMA analysis, allows medicines to be used throughout the EU, without the need for a time-consuming and expensive country by country process where the same work is done again and again by different people.
This means significant economies of scale and cost savings for both governments and pharmaceutical companies, which in turn makes drugs cheaper and in the end means more people will get access to the ones that work well.
How the EMA works
The EMA has a maximum of 210 days to come to a decision. This can be reduced to 150 days if accelerated assessment is requested by the company because the medicine addresses an unmet medical need, i.e. offers a major therapeutic advantage over existing treatments, or benefits patients with no current treatment options for their disease.
This means an exhaustive scientific assessment of the data provided on the medicine, so as to determine whether its benefits outweigh any possible risks of harm. These are not decisions to be taken lightly. Premature authorisation of a drug could mean that dangerous or debilitating side effects go undetected, putting patients’ wellbeing at risk. We can all remember scandals from the past.
In the course of the assessment, concerns may be identified that require further information from the company. In this case, the clock is stopped to give the company time to reply. This is what happened with palbociclib. The EMA review of the marketing authorisation application for palbociclib started in August 2015.
After 120 days, in December 2015, the EMA stopped its assessment to ask a number of critical questions – because it did not have enough information to conclude the benefits for patients would outweigh the risks.
In February 2016 the company asked for additional time provide their answers to these questions. That is why the medicine is not yet recommended for approval.
Since then, the company has submitted its response and the EMA has re-started its assessment.
Once a medicine is authorised, it is up to national authorities to decide, on the basis of analysis by assessment bodies (NICE in the UK) whether public health services will purchase the drug. The EU is not involved in this process.
Since 2006, the EMA has approved 108 medicines for the treatment of cancer. In 2015, 17 new medicines against cancer were authorised, e.g.:
- Blincyto – a new drug to direct the immune system to attack cancer cells
- Farydak – a medicine to regulate the activity of genes
- Imlygic – a gene therapy using a genetically engineered virus to kill cancer cells
- Opdivo, Nivolumab BMS and Keytruda – a group of new medicines to enhance the capacity of the immune system to fight cancer.