Innovation is the Key Driver of the Biopharmaceutical Industry
Europe Needs to stimulate Biopharmaceutical R&D and Reward Innovation
The process of biopharmaceutical research and development is a complex, costly, risky and extended undertaking. It requires the mobilisation of substantial human and financial resources over a long period before a new drug finally reaches the patient. On average, this process takes between 10 to 15 years and the estimated average cost of developing a new medicine exceeds € 1 000 million.
The development of new technologies has provided a basis for break-through innovation, resulting in many better and safer medicines. However, there has been widespread concern about Europe’s loss of competitiveness and attractiveness for R&D in pharmaceuticals and biotechnology, in comparison with the US.
Looking at the future direction of healthcare, one thing is certain: new, innovative medicines will continue to occupy an important role in the way we improve the quality of care. The future of biopharmaceutical development in Europe is dependent on Europe’s innovative capability, a strong science base, the capacity to attract high levels of investment in R&D as well as a favourable regulatory framework that protects and rewards innovation.
EBE believes that the current EU regulatory framework needs improvements to ensure optimal progress and implementation of emerging technologies, including regenerative and personalised medicine, model-based drug development and nano-biotechnology. Overall, a more predictive regulatory environment is needed so that industry can develop novel, innovative therapies to treat serious, unmet medical needs. This requires the reduction of scientific regulatory hurdles impeding the efficiency of the discovery and development process. The introduction of more flexibility and increased interaction with regulatory agencies would enable the safe acceleration of drug development using new technologies and innovative techniques.
Biotechnology is crucial for medical innovation since almost 50% of all medicines in the R&D pipeline are biotechnology-derived. The development of biopharmaceuticals presents challenges that are different from the development of chemical-based pharmaceuticals.
Although this is acknowledged in regulatory guidance, there is room for further improvement.
- Eurostat Report on “Science, technology and innovation in Europe” – 2009 edition.pdf
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- Eurostat report on "Biotechnology in Europe - Patents and R&D Investments", August 2007
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- Life Sciences and Biotechnology Strategy 2002-2010
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- Commission Communication on mid-term review of Strategy on Life Sciences and Biotechnology, April 2007
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