teaser
By Merryn Johnson
After a decade at the helm of the European Medicines Agency, departing Executive Director Thomas Lonngren has now completed his second and final five-year term. Here he tells HPE about some of the challenges and rewards of working at the top of pharmaceutical regulation.
As a decentralised agency in charge of evaluating medicines developed by pharmaceutical companies for use within the EU, the EMA has a certain autonomy, as Lonngren emphasised: “We are dealing with the scientific, of course, and not the political.”
Scientific or political, it is a role with a lot of responsibility, and a lot of weight, but Lonngren’s 30 years of experience in the pharmaceutical regulatory industry stood him in good stead.
Before joining the EMA he was Director of Operations and later Deputy Director General of the Medical Products Agency in his home country – Sweden (formerly the Pharmaceutical Division of the Swedish National Board of Health and Welfare).
When Lonngren joined the agency in 2001, he was in charge of a team of 150. Now the agency employs nearly 800 people, manages six scientific committees and 35 working parties. They have a network of over 4,000 experts across 44 drug-licensing authorities in 30 countries.
And from their imposing offices on Canary Wharf, London, the agency’s budget for 2011 is 250m.
As well as drug authorisation, the EMA is responsible for issuing guidelines for the development of new medicines for the industry. They also conduct ongoing monitoring of all the medicines in the EU market.
“We are responsible for the evaluation of new medicines that the industry want to put on the markets and we have a responsibility to follow up on these medicines once they are on the market. And the safety issue is always coming up on our table. A recent example was Avandia.”
Avandia (rosiglitazone) is a GlaxoSmithKline anti-diabetes drug, which was first granted marketing authorisation in 2000, despite rosiglitazone being associated with fluid retention and increased risk of heart failure. EMA kept this risk under close review and introduced restrictions according to the data available. Eventually the agency’s committee decided that the benefits of rosiglitazone no longer outweighed its risks and pushed for its suspension in September 2010.
As Executive Director, Lonngren has steered the EMA through various problems.
“There have been so many challenges, and responsibilities, and tasks. A big issue came with the flu pandemic. It was a big challenge to get approval for the vaccine for the European population but we were prepared.
“We already had procedures in place. We were the only regulator in the world who had a vaccine approved. We already had the results from clinical trials for the H5N1 vaccine.
“It was a huge job for the agency: working more hours, the need to get this vaccine approved, requirements for manufacturing and all the coordination with other health agencies in Europe. It was very unpredictable.”
Another challenge has been the general ‘tough economic climate’. But over and above troubles in the banking world, the pharmaceutical market is floundering.
Lonngren said: “I think the pharmaceutical industry has its own recession. There are very few medicines that are coming out, but there is a huge amount of money put into research and development.
“This trend of declining numbers of molecules being discovered doesn’t seem to change direction. There are many reasons for it and no one really knows the main causes.”
Despite these ups and downs, looking back at his ten years at the EMA, Lonngren’s enthusiasm for his job is apparent: “The science is the most interesting part of the job – to work with medicines, to be able to make sure they are not dangerous. Everything around us is very rewarding.”
The EMA has had a few hitches in finding a replacement for the top spot. A translation mistake in the German version of the recruitment advert, issued early in 2010 – which asked for physicists rather than physicians – meant that the whole process had to start again in late October.
He expects that his successor will be in place by mid-2011 and leaves them with a few words of encouragement: “He or she is coming on board with an organisation that’s very well equipped in the way of performing very well.
“This is a fantastic job. It’s a privilege to have this job which in my profession is probably the highest one can get and I enjoyed every moment of it.”
* Thomas Lonngren has now joined the DNA Group – a new European regulatory and market access business – as a strategic advisor.
