Research & Innovation
Science has always been at the core of what the pharmaceutical industry is about. The industry has consistently invested in science, knowing that the fruits of R&D can add years to life, and life to years. With fast developing technologies such as epigenetics, which looks at how particular genes vary in their expression, as well as faster and cheaper access to the human genome, the reality of leveraging “the new science” to develop medicines personalised to the individual is on the cusp of being realised. This does not mean that traditional R&D has ceased to bear fruit. Indeed, 2011 saw a small but high quality number of new medicines being made available including two ground-breaking treatments for advanced melanoma and two new treatments for Hepatitis C.
Europe has continued to increase in importance as a location for investment in pharmaceutical R&D over the past decade. In 2011, the industry invested Euros 27.5 billion in R&D in Europe. However, the combination of rising R&D costs, complex research areas, and burdensome regulatory requirements, make for a challenging environment for healthcare innovation in Europe in the coming years. Europe’s ability to remain a leader in biomedical innovation depends on regulators, industry and civil society developing new models of collaboration to research areas of unmet need.
Europe’s clinical trials regulatory framework is a key challenge. It is fragmented and does not currently take account of new tools such as biomarkers, or that old medicines can be repurposed for new treatments as a result of new research. A streamlined clinical trials framework in the EU will be key to encourage research and innovation.
Use of animals in research and testing is a highly sensitive, yet vital part of the long and complex process creating new medicines. Our industry has focused its efforts into replacing, reducing and refining – the 3Rs – its usage of animals. Constant search for better and more predictive research tools and pathways also impact the 3Rs impacts. Please, also refer to the following webpage : Animal Welfare and the European Pharmaceutical industry - explain, track and talk.
The European pharmaceutical industry is an enthusiastic supporter of European Commission’s proposals for a new EU Framework for Research and Innovation – Horizon 2020. The programme is designed to create a knowledge-based economy in Europe capable of competing on a global scale over time. Out of the total budget of €80 billion, €9 billion has been earmarked to address major concerns shared by all Europeans in the field of health, demographic change and well-being. At the heart of the proposed programme is an emphasis on public private partnerships.
The Innovative Medicines Initiative (IMI) is a unique collaborative venture – a public private partnership - between the European Commission (EC) and European pharmaceutical companies, SMEs, regulators, academia and patient groups. With a total budget of € 2 billion, IMI is the world’s largest public-private partnership in life science funded jointly by the European Union (€1 billion in cash) and EFPIA (€1 billion in in-kind contributions). Projects cover the entire value chain, from discovery, through preclinical and clinical research, to Health Technology Assessments (HTAs) and pharmacovigilance. In 2011, companies agreed to pool knowledge and co-fund research under the IMI programme in the vital areas of depression, rheumatoid arthritis, pain and antibiotic resistance.
Fundamental to the industry’s business model is intellectual property rights (IPR). Traditionally, the EU has had a robust framework of protection of IPRs in line with the EU’s 2020 vision of a knowledge- based society.