Brian Ager
Director General
European Federation of Pharmaceutical Industries and Associations (EFPIA)
For over 100 years, a large number of new and innovative medicines were developed in Europe and made available to patients to alleviate their suffering and improve their health. Through intensive, lengthy, highly complex and dedicated research effort, carried out by research and development (R&D)-based pharmaceutical companies, new generations of therapies have been introduced that have revolutionised healthcare, making once life-threatening diseases uncommon and allowing millions of people to be treated and lead longer, better or more normal lives.
Major achievements have been made in the treatment of infectious diseases and childhood illnesses, some forms of cancer, nervous disorders, stomach ulcers, asthma, hypertension and diabetes, to name but a few. Consequently, whereas just surviving childhood was a challenge in 1900 and the average life expectancy in Europe was then only 55, a child born today can expect to live until almost 80.
Today, in European laboratories, 102,000 industry scientists are researching and developing new cures and better treatments for cancer, heart disease, HIV/AIDS, Alzheimer’s, Parkinson’s, arthritis, osteoporosis, cystic fibrosis and many other diseases. Only within the last decade, pharmaceutical companies developed three new classes of HIV/AIDS drugs, three new classes of cardiovascular drugs and two new classes of medicines against Alzheimer’s disease. Many breakthrough treatments have been developed for other indications.
Progress through research and development
Through its massive R&D investment, the research-based industry represents our society’s best hope to fight, defeat and eventually eradicate a wide range of illnesses that are costing a fortune, not to mention pain and suffering. In 2006 alone, the pharmaceutical industry in Europe has invested over €22.5bn in R&D, which accounts for 18% of the whole EU business R&D expenditure. Huge as industry’s R&D investment is, however, it is by no means a guaranteed path to success. Due to the growing understanding of the scientific basis of diseases, the complexity of regulatory requirements and “administrative” delays, it now takes an average of 12–13 years to turn a new promising compound into an approved medicinal product. The average medicine has then about 8–10 years of effective patent protection left by the time it reaches the pharmacy shelves before facing stiff generic competition. The result is that each new medicine now costs in the range of €900m to develop, that half the medicines that reach the final stage of clinical trials fall at that hurdle, and that only three out of 10 marketed medicines produce revenues that match or exceed average R&D costs.
Statistics indicate that of every 5,000 molecules tested only 250 promising new medicines will enter preclinical testing, and only one will be approved by regulatory authorities and granted market authorisation.
A cause for special concern is that Europe, over the last 15 years, has been losing gradually ground as a research base, with a steady transfer of its R&D to the USA – where the environment is more attractive for R&D investment and more supportive of pharmaceutical innovation. Key benchmarking indicators show that in 1990 the global research-based pharmaceutical industry still invested roughly 50% more in Europe than in the USA. But today the same industry is investing 40% more in the USA compared with investments in Europe. Even the major EU pharmaceutical companies have changed the distribution of their R&D spending to the benefit of other regions.
The AIMS of the EFPIA
Against this background, our main challenge in Europe is to reverse these negative trends in order to be able to continue to innovate. So what are the priorities? The way forward for Europe is to strengthen its science base and to improve the competitiveness of its research-based pharmaceutical industry by setting up a regulatory and political environment, which above all stimulates R&D and rewards innovation. Under the leadership of Arthur Higgins, our new president, we shall focus industry’s efforts around four key areas regrouped under the “AIMS” (Access, Innovation, Mobilisation, Security) umbrella.
European patients should have faster access to new innovative therapies. Today, patients across Europe are not getting speedy and equal access to innovative medicines, essentially because of delays in pricing and reimbursement decisions, which take place at national level. Consequently, more than two years may elapse from the awarding of a marketing authorisation before a new medicine becomes available on some national markets. This is clearly unacceptable. The time needed for setting reimbursement prices at national level must be shortened, in line with the time limits set by the Transparency Directive. We also want to remove government controls on medicines that are not reimbursed and ensure that Health Technology Assessment does not become a fourth hurdle to market access.
Secondly, we must improve stakeholders’ understanding of the value of innovation, including incremental innovation, for patient and society and secure sustainable funding mechanisms for innovative drugs. In the context of the High Level Pharmaceutical Forum – the current strategic policy dialogue on European competitiveness with respect to the pharmaceutical industry – the European Federation of Pharmacy Industries and Associations (EFPIA) is putting forward concrete recommendations for an optimal balance between enhanced competitiveness and improved public health. A key deliverable is to ensure that the IMI (Innovative Medicines Initiative) becomes a reality by the first half of 2008. By gathering expertise and resources from the public and private sectors, IMI will provide a framework for the conduct of precompetitive collaborative research to develop new tools and technologies for safety assessment, efficacy evaluation, knowledge management and education. This will increase the efficiency of drug discovery and development, enabling more effective and safer medicines to be developed to meet the needs of EU citizens. Importantly, IMI will help to maintain and augment the European science base in order to make Europe more competitive and an attractive place for biopharmaceutical research investment.
Thirdly, we want to encourage more multistakeholder debates on how we can create a more modern and sustainable healthcare system. We need to mobilise all stakeholders to work together and identify solutions for providing modern healthcare. Mobilisation also means to ask patients and citizens to take a more active role and responsibility in managing their health; in turn, they will demand to be better informed in making their health decisions.
We seek a liberalisation of health information but no direct-to-consumers advertising. Mobilisation is also about the need for all stakeholders to join forces to improve access to medicines and healthcare for those who live in poverty. The European pharmaceutical industry is leading the battle against neglected diseases in the developing world. We need to continue developing innovative approaches while, at the same time, better communicating our contribution.
Fourthly, with patient safety as our priority focus, we want to strengthen the security of the pharmaceutical supply chain. It is ironic that, with all the regulations in place to ensure the safety of our products, once a pharmaceutical product leaves our factory we are no longer able to guarantee that the same product reaches the patient. Parallel traders are allowed to repackage our products, destroying our ability to track and trace, and exposing the supply chain to an increased threat from counterfeits. To improve the security of our supply chain, we shall put in place a pilot system that facilitates the tracing of our products.
