The current growth experienced by pharmaceutical and biotech enterprises in the U.S. and the EU is beyond any doubt. From a business standpoint, biotechnology poses significant challenges as regards aligning the spirit of scientific discovery and research with the world of business and finance. Research processes and the returns on research activity take a long time to bear fruit, and such projects therefore require specialist management and financing expertise.
From a legal perspective, biotech firms require an all-embracing approach to legal advice which takes into account EU, central government and autonomous community law. Biotechnology work is governed by a specific and yet multifaceted regulatory framework, as well as individual agreements and collaborative projects, such as those used in product development or in CENIT (National Strategic Technical Research Consortiums) projects. Specialist tax advice is also required on industry-specific issues, such as incentives for innovation and R&D to name but one, and all of this without going into the problems posed by patents, the status of government researchers, clinical trials, tissue banks or the specific rules on personal data protection.
Garrigues has forged significant and promising ties with the world of biotechnology: on July 12, 2006, Garrigues and the Spanish Association of Biotechnology Firms (ASEBIO) signed a collaboration agreement to provide legal services to new or recently-formed biotech start-ups, while on January 30, 2007, the firm signed an agreement with the Valencia Association of Biotechnology Firms (BIOVAL) to provide start-ups belonging to that association with legal assistance. A further coup has been the agreement signed between Garrigues and Sanitas on April 11, 2007, raising awareness of the scientific and legal advances in the field of biomedicine.
The activities of biotech firms take place within a stringent regulatory framework and Garrigues has a proven track record on providing legal advice to enterprises and entrepreneurs in the industry. Specifically, we have garnered experience in areas such as:
- Tissue banks. Umbilical cord banks
- Genetic analyses
- Importing and exporting samples and tissues
- Tissue engineering
The pharmaceutical industry
- Marketing Authorizations. Transfers in processes involving the alternation of legal form.
- Clinical trials. Due diligence reviews of compliance
- Hiring CROs and professionals in this discipline
- The taking of R&D&I tax credits (including advice on inspections in which the use of such tax credits is challenged)
- Functional foods and ingredients
- The regime governing genetically modified organisms