Regulatory issues in the life sciences sector
An understanding of the regulatory environment in which our life sciences and healthcare clients operate is fundamental to our ability to offer a full service. Accordingly, we work across the entire range of life sciences and healthcare activities, including pharmaceutical, biotechnological and medical devices.
We have good working relationships with both national and centralised regulatory authorities and assist our clients in understanding the relevant regulations, maximising their use of them, prosecuting authorisations and, thereafter, enforcing their rights. When necessary, we have represented clients on regulatory matters before the national and European courts (eg, in cases concerning permissible advertising and labelling for pharmaceutical products).
Recent areas of the group's work has involved it in assignments relating to:
- data-packaging exclusivity
- orphan-drug designation
- repackaging in the context of parallel imports
- clinical-trial regulation
- the effect of the introduction of a bolar provision into European regulatory law
- review of the new Community Code
- new draft Technology Transfer Block Exemption
- Internet advertising.