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What is life sciences law?

Text: Herbert Zech

Different areas of law work together in the field of life sciences to provide a framework that promotes the development and spread of new technologies, minimizes the risks associated with their use, and sets boundaries where necessary.

Why do we need law? This is a question not just for lawyers but also for the public, which in Switzerland can make laws directly. At issue here is the function of law. Since Immanuel Kant, if not earlier, we have known that law is not to be confused with morality, and it was Charles de Montesquieu who said, “If it is not necessary to make a law, it is necessary not to make a law.” Laws are there to intervene when society would not work without them. This also applies to the field of competition – the law steps in when markets are at risk of failing.

The Law Faculty at Basel University has a particular focus on the field of life sciences. Medicine, pharmacology and agricultural technology have one thing in common: They are increasingly using living organisms as tools, a development also known as biotechnology. The life sciences therefore deal with organisms both as subjects – human patients, animal patients and plants undergoing treatment – and as objects i.e. tools for human use.

The implications for the law are twofold. On the one hand, this is a matter for traditional technology law – law dealing with the development, application and consequences of technology, where technology is understood as the application of knowledge underpinned by science. On the other hand, life sciences law needs to set ethical boundaries for the treatment of people and animals. The Law Faculty is exploring both areas.

For technology lawyers such as myself, the role of life sciences law is to deal with the life sciences as an especially innovative and cuttingedge technology. It has several key functions in this regard. Life sciences law promotes innovation, facilitates technology transfer, regulates risks – by minimizing risks and setting admissible limits – and allocates the permitted risks by means of liability provisions.

Promoting innovation is traditionally the domain of intellectual property (IP for short). Through patent protection, in particular, it seeks to incentivize investment in the development of new technologies. The second function of intellectual property is to make knowledge tradeable. In addition, the law provides further necessary regulation in respect of technology transfer, especially contract law and antitrust law, which removes barriers to competition.

Risk regulation is the domain of public law. The traditional paradigm was that of danger defense, the aim of which was simply to prevent unacceptable risks, through legal prohibitions and licensing requirements. This has developed into a modern form of regulatory law that provides a wide range of incentives to permit and enable technological risk-taking, where the anticipated social benefit outweighs the harm, while ensuring that unnecessary risks are avoided.

A central concern in this regard is the assessment of the risks arising from new forms of technology, such as gene technology or nanotechnology. This is where the last function of the law comes into play – to allocate risks, where they are judged admissible, to their likely beneficiaries. Ensuring that risks and benefits are linked is not just a question of equity; well-drafted liability provisions also serve to encourage the developers and users of new forms of technology to minimize risk.

In this way, different areas of law are working together in the field of life sciences to establish a legal framework that promotes the development and spread of new technologies, minimizes the risks associated with their use, sets boundaries for their use where necessary, and imposes responsibilities for risks, including financial liability. Lawyers are involved in this process both as users and as advisers on the framing of legislation.

Fundamental questions such as whether and to what extent gene technology should be used need to be decided democratically, but the detailed drafting of legislation calls for specialist legal knowledge. That is where legal research comes in. It is dealing with a wide range of topical issues, from gene technology to stem cell research to new types of medication. Basel provides an ideal setting for this work. The Centre for Life Sciences Law at Basel University’s Law Faculty is set to make an important contribution to research and teaching in the field.

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