Sophia Antipolis, 9 July 2013.
A resurgence in cardiovascular R&D is urgently needed to curb a new epidemic of cardiovascular diseases, according to leading cardiologists and industry representatives in the Cardiovascular Round Table (CRT).
The CRT is an independent forum established by the European Society of Cardiology (ESC) and comprised of cardiologists and representatives of the pharmaceutical and medical device industries. The group’s views are outlined in “Championing Cardiovascular Health Innovation in Europe”, published in European Heart Journal (1).
Professor Michel Komajda (Pitié Salpetriere Hospital, Paris), past-president of the ESC and lead author of the paper, said: “Research and development in pharmacology for the management of cardiovascular diseases has been extremely powerful and efficient in Europe so far. The 30 day mortality after myocardial infarction has been more than halved in 20 years thanks to the new anti-thrombotic agents. The European economy has also benefited from the creation of high and middle profile jobs.”
However, “we are worried that the period of improvement in treatment is reaching a limit,” he added. The population is aging and there is an increase in comorbidities such as diabetes and obesity which induce cardiovascular diseases. At the same time research and development in CVD pharmacology is slowing down.”
CVD is the leading cause of death in Europe but has not occupied a place in the top 5 active research areas since 2005. The CRT paper outlines how, compared with other medical areas, CVD related R&D is in steep decline. The authors state: “This is mostly due to the impact of complex regulation which drives up development costs and delays time-to-market for new cardiovascular drugs.”
They add: “The recent closure of mainstream R&D facilities in Europe is clear evidence of an investment crisis that has to be addressed and a regulatory environment that must be simplified without compromising patients’ safety which is our utmost duty.”
Research and development has moved to other geographic regions and medical areas that are likely to yield better returns. There is a risk that cardiologists will not have access to the optimum treatment techniques at a time when a new CVD epidemic is gaining ground in Europe.
The authors recommend that a forum be established to discuss how to rejuvenate cardiovascular R&D in Europe. It should consist of EU representatives, national healthcare authorities and finance ministries, academia, medical societies and representatives of the pharmaceutical and medical device industries.
Their agenda should include:
- Reviewing the issues driving R&D investment to other geographical and medical areas
- Simplifying the clinical trials environment
- Targeting EU funding through tax incentives and sponsored development programmes
- Reviewing patent duration in the context of development timescales and investment
- Encouraging cross-border and cross-discipline collaboration and networking.
Prof Komajda said: “As a professional society, the ESC believes it is our task to highlight how declining cardiovascular innovation threatens the availability of new treatments in Europe, a situation which leaves European citizens short of needed innovations and risks damaging the economy. We set up the CRT to increase awareness of these issues and kick start solutions.”
He concludes: “A new epidemic of cardiovascular diseases is taking hold in Europe. Urgent steps are needed to halt this epidemic by removing the barriers to cardiovascular R&D in Europe.”