The EMA has also been collaborating with the European Heart Network (EHN) with respect to World Heart Day. The EHN is an alliance
of heart foundations and nongovernmental organisations throughout Europe, with member organisations in 26 countries. Using
advocacy, networking, education and patient support, the EHN seeks to play a leading role in the prevention and reduction
of cardiovascular diseases. The EHN believes that 80% of current cases of cardiovascular disease can be prevented and that
even small reductions in incidence and mortality will result in large health gains and reductions in direct and indirect healthcare
costs (5). With this in mind, EHN and the European Society of Cardiology created a joint project called EuroHeart. The project
involves partners in 21 countries in the EU and the European Economic Area, and receives funding from the European Commission
Public Health Programme. The first EuroHeart ran from April 2007 to March and focused on five core areas, including the impact
of cardiovascular disease on women and the implementation and adaptation of European guidelines on disease prevention to national
situations. EuroHeart II is now underway and will analyse the current situation regarding cardiovascular disease in the EU
with the goal of developing a long-term strategy. In particular, the EHN is keen to develop measures for less-advantaged groups.
The fight against cardiovascular disease now has a high political profile thanks to the EHN and European Society of Cardiology.
These two organisations manage the Secretariat for the Members of the European Parliament (MEP) Heart Group. This forum is
made up of MEPs who have an interest in promoting measures to tackle the threat of cardiovascular disease. Several of the
members have a medical background, although there is no restriction on the MEPs who can become involved. The group has been
heavily involved in raising the profile of World Heart Day at a political level to influence EU health policy. In March 2011,
the MEP Heart Group held a meeting to examine how e-healthcare initiatives could be tailored for cardiovascular disease. Its
October 2011 meeting examined how learnings from the United Nations Summit on NonCommunicable Diseases could be applied to
the group's own objectives.
Opportunities for the pharma industry?
For the pharmaceutical industry, cardiovascular disease is an important commercial target for treatments and diagnostic tools.
Typically, the cardiovascular therapeutic area comprises around 15% of the total pharmaceutical market (6), and Europe's political,
regulatory and medical emphasis on improving the outlook for cardiovascular health should create further opportunities for
companies to market products in this therapeutic area. Despite the expected demand, however, pharma companies are concerned
that cost pressures and cautious regulatory approaches will stand in the way of innovative therapies. It is also unlikely
that the EMA's ongoing Multaq review will add to the industry's confidence.
At the 2010 European Society of Cardiology's annual meeting, the organisation's president, Roberto Ferrari, was cited as implying
that cardiology had become a victim of its own success (7). Although noting that therapeutic advances in cardiovascular medicine
had increased average life spans by about 7–10 years, he also added that regulatory demands were increasing, particularly
regarding the required size of clinical trials; large-scale trials inevitably drive up the expense of the development programme.
One fear expressed was that companies might choose to reduce investment in the cardiovascular area and preferentially focus
on therapy sectors seen as more profitable, such as oncology.
But it's not all bad news on the regulatory front regarding pharmaceutical innovation in this therapy area. Since 2006, the
European Federation of Pharmaceutical Industry Associations (EFPIA) has been working with the EMA to develop reliable biomarkers
for cardiovascular drug development and in 2009, a workshop was held to discuss the possibilities (8). As biomarkers represent
substitutes for clinically meaningful endpoints, their regulatory acceptance would revolutionise cardiovascular drug development
by shortening development times. Potential candidates fall into three areas: laboratory markers, physiological parameters
and imaging biomarkers. Current thinking is that a cluster of biomarkers will be needed to make progress, as well as collaboration
between the pharmaceutical industry and EMA. Fortunately, it does appear that both sides are eager to cooperate and this bodes
well for the development of new cardiovascular therapies in line with public health objectives.
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