Find Lawyers in Spain for Biotechnology and Life Sciences Practice
I am head of the Life Science Department. I have an extensive knowledge in all kinds of legal matters affecting the pharmaceutical and healthcare industries, including regulation (pricing and reimbursement), advertising, anti-trust and EU law, commercial contracts, data protection, and product liability. I advise national and multinational companies in the pharmaceutical, cosmetics and food industries. I am a member of Conferénce Bleue (Europeans Lawyers’ Conference on Pharmaceut...
Borja began his professional career in the EU and Competition Law Department at Uría Menéndez, working in both the Brussels and Madrid offices. He has been on secondment to the antitrust and competition law departments at Skadden, Arps, Slate, Meagher & Flom (New York 2004-2005) and at Slaughter and May (London 2008). Since 2015 he has been Director of Competition Law of the Regulatory, Administrative and Competition practice at KPMG in Spain . He specialises in advising and...
I am a senior associate in the Life Sciences Department of Fieldfisher-JAUSAS. My professional career spans more than 15 years as a counsel for companies in the pharmaceutical and healthcare sector. I specialise in regulatory law, in particular, in sectoral codes of conduct and compliance policies applicable to the pharmaceutical sector. I have also worked as an in-house legal counsel for companies in the aforementioned field to help them implement internal procedures for compliance with code...
Biotechnology and Life Sciences Practice Definition
Spanish hospital doctors and scientists are active investigators in Biotechnology related health matters, usually leading to new intellectual property assets.
Scientific investigation, particularly that involving the use of human samples, is highly regulated in Spain, as occurs in many other countries, involving both national and regional laws and rules, connected with Administrative rules and IP rights protection.
Doctors and researchers, sometimes even Transfer Offices staff, are not familiar with that complex regulation which includes very different legal fields such as those related with the Intellectual Property and the use of human samples in biomedical research, among others.
Research in health public institutions leads to results that need to be protected and transferred. There is a long list of questions that arise in this process among which are the following:
- identify the true inventors/creators and owners
- detect previous contracts assigning rights over the results and the IP derived therefrom
- identify assets to protect
- decide the best way to protect those results
- stablish joint ownership agreements, if any
- negotiating and drafting transfer agreements with industry
Lawyers can be very helpful throughout that process, making easier the work of researchers and transfer staff and ensuring the entire process is done within the legal framework jurisdiction.
Use of human samples in biomedical research
The use of biological samples for biomedical research is subject to very strict legislation in Spain and its failure can undermine the publication of scientific results and the transfer options thereof.
Researchers must be sure to comply with the legislation in force regarding obtaining human samples and subsequent conservation and uses thereof, particularly regarding to the following:
- Patient consent
- Samples conservation in registered collections or Biobanks
- Permitted uses: only for a particular research project, a research field or for any health investigation
Lawyers can be very helpful assessing researches and technology transfer offices staff to obtain and maintain human samples in compliance with rules and legal requirements, from the design of the research project protocol to the final step of transferring research results to industry.
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