Biotech Industrial Innovation Management.
Priority for Europe in the Global Change.

The Centre responds to the European priority of the biotech industrial innovation management in globalisation.

The scientific and technological progress in life science and biotechnology is rapidly developing. Advantages and repercussions on several levels (individual, social, economic, and scientific) have consequently generated a strong public debate on sustainable biotechnology.
From the scientific standpoint, the biotechnology development is a source for a therapeutic and medical progress, as it allows the discovery and realisation of new diagnostic tools and therapies able to contrast human diseases still incontrollable. As preventive treatment is more and more replacing hospital care, we can legitimately expect a substantive increase of these figures. The potential of a number of new technologies, such as stem cell applications, requires further investigation. A revolution in health-care is more to be anticipated through a shift towards prevention rather than throughout cures and personalised medical treatments by means of genetic medicines, genetic testing and new gene technology. Moreover, in the agricultural sector, the biotech impact is related to new more resistant crops, endowed with high quality standards, whose goal is to improve both the productivity of developed countries and the life conditions of developing ones.
With regards to the environment, the biotechnology allows the development of innovative strategies finalised to industrial sustainability. Biotechnology is reputed to be a powerful technology for the creation of clean industrial products and processes such as biocatalysis. Benefits have been in fact shown for traditional industries like textiles, leather and paper.
Bioremediation is also able to clean-up polluted air, soil and water: bacteria have been used for a number of years to clean up oil spills and purify waste water.

On the other hand, from the governance standpoint, European countries shall ensure competitive, safe and compatible primary production and processing methods with sustainable medical, scientific, agricultural practices to reduce risk and impact. Moreover, in the development of policies, potential long-term risks related to the environment (particularly referring to biodiversity) of some applications of biotechnology, should be taken in account.
As mentioned in the Consultation Document of the European Commission (September 2001), “life sciences and biotechnology raise different types of issues which should be addressed at the appropriate level in accordance with the subsidiarity principle. In some areas, the Community has a clear responsibility (for example concerning trade and internal market implications as well as handling the implications of life sciences and biotechnology on existing Community policies), in others, the responsibility lies overwhelmingly with the Member States (e.g. on setting the ethical principles). The cross-cutting nature and importance of life sciences and biotechnology and their implications call for a careful reflection on overall coherence and on the involvement of civil society and stakeholders”.
Europe is a world leader in harnessing genetically modified micro-organisms (GMM) to produce pharmaceutical compounds and industrial enzymes. In the pharmaceutical field we find production of therapeutic protein products such as insulin and growth hormones, while in the industrial one we have uses related to food as well as in detergent industries and bioremediation. All this happens in sealed systems and the final product neither is a GMM nor is directly derived from one of them.
Biotechnology also represents a key driver of progress in the pharmaceutical sector, whose end-user benefits may easily be identified. Biotechnology allows the development of new cures; it also permits yields and quality to be improved and enables existing pharmaceutical products to be manufactured by limited impacts on the environment.
The pharmaceutical sector is highly regulated and it is already covered by substantial Community legislation; new pharmaceutical products are subject to regulation under Directive 65/65 and its supporting legislation, notably Regulation 2309/93. Any product (whether biotechnological or not) endowed with medicinal claims is required to meet strict quality, safety and efficacy standards; under Regulation 2309/93 all new products with a major biotechnological component are subject to centralised assessment by the EMEA. Given the considerable barriers to market entry of these products, the regulatory system should seek to avoid unnecessary difficulties for biotechnology companies’ efforts to compete and bring pharmaceutical products to market.
For example, there may be scope for streamlining the approvals system in order to eliminate unnecessary overlaps between the new Clinical Trials Directive, Community regulation on GMOs, and continuing local level ethics committees and regional approvals.
If the above mentioned aspects represent the progress level of biotech in ordinary and general activity involving human being, then it will be necessary to reflect on the slowing factors of biotech development.

All this considered, European countries should play a role for developing coherent and innovative management policies able to satisfy all different standpoints and to compose the opposite requirements.
To realise this purpose in the global challenge, we believe that European countries are called to develop and jointly perform a strategy oriented to improve three main elements in order to give a substantial boost to biotechnology:
a. regulation;
b. innovation and competitiveness;
c. shared ethical guidelines.
As far as regulation is concerned, we refer to the internal and external level of normative approach on biotech matters. On the external level, European countries have to ultimate the process of normative harmonisation in order to create a coherent and general sector legislation. On the internal one, European countries have to improve their regulations on biotech aspects in order to create the legal premises for research. In Europe there are many differences from a regulation standpoint: in 2004, for example, Italy adopted a very restrictive regulation of assisted procreation, while Great Britain widely allows the scientific research on human embryo for therapeutic purposes.
A convergence on these aspects from all European countries would be extremely useful for the development of a competitive system.
Innovation and competitiveness are stimulated by several factors, such as:
- industrial structure: commercial biotechnology is often described as being characterised by a division between “upstream” dedicated biotechnology firms (reputed to be the hard core of biotechnology innovation) and “downstream” corporations. Most dedicated biotechnology firms lack necessary resources to bring a product all the way to its final market;
- human resources: Europe benefits from a very strong academic scientific base, with a world-class presence in many scientific fields. European scientists produce about as many as ¾ of published articles and scientific citations as their American counterparts. All this is encouraging, if we consider that US public budget for biotechnology research is some four times greater than the combined total of the comparable Member States’ and Community’s programmes. Nevertheless the strength of US commercial biotechnology, stimulated by high public investments on biotechnology research, has led to strong demand for life scientists in USA. Such a fact has stimulated a significant “brain drain” from Europe, which still has insufficient commercial biotechnology activity in comparison with academic activity;
- intellectual and industrial property rights: in the biotech industry, knowledge represents the added value. For biotech enterprises the principal expense is related to research and experimentation activity on products before its commercialisation. The biotech enterprises must protect their inventions through patent proceedings, which give to the titular the exclusive right to develop a product; nevertheless, at the same time, the relative innovative information is at everybody’s disposal. In this prospective, Directive 98/44/CE plays a fundamental role in the creation of a valid normative framework on patentability. All European countries are therefore called to assimilate it.
In order to develop the above mentioned aspects, European countries should be diligent in the realisation of a system which promotes and improves biotech enterprises’ mechanisms.
Finally, European countries should share their fundamental rights and values regarding the protection of the human being protection. Ethical protection and respect of ethical and cultural aspects should have an important role in European policy.
The rapid progress of scientific knowledge and technological potential of life sciences and biotechnology oblige us to continuously set priorities and encourage certain developments while placing restrictions on others. As a consequence, European countries need to identify, and even anticipate, the ethical issues, to provide focused advice on often technically complex matters, and to make available the relevant facts to facilitate societal scrutiny and debate.
In order to obtain a progress on the three key elements of biotech development, it is important for all European countries contributes to improve and give a substantial boost on biotech activity and relative applications, being biotech a focal point for economic and sustainable progress.