Advanced Therapy Medicinal Products are defined as medicines based on gene therapy, somatic cell therapy or tissue engineering.  A rapidly growing area in translational research, these represent the ‘next generation’ of complex, personalised treatment solutions.

ATMPs present particular legal challenges.  Far removed from the established ‘pill paradigm’, regulatory parameters, best practice and legal stipulations are still being shaped and discussed.  Legal and regulatory advice on the parameters of ATMP manufacture and use is essential, particularly in the pre-clinical and early clinical phases of product development.

We understand that clients developing ATMPs are focused on the scientific excellence of the treatment solution, and are frequently frustrated by the uncertain regulatory situation that still persists with ATMP when they first encounter it.

Dialogue with regulatory agencies can be immensely helpful, but regulators cannot give legal advice or shape strategy.

Lawford Davies Denoon can provide advice and assistance with these and other questions:

•    In a complex patent landscape does our team even
     have freedom to operate without infringing
     another’s patent?
•    Does our intellectual property hold up to scrutiny?
•    How can existing know-how be mobilised as a
     bargaining chip?
•    Are there any legal ‘tricks’ to strengthen the
     strategic position?
•    If marketing authorisation is granted, will we be able
     to secure reimbursement?
•    How must the team handle its research data to make
     it a saleable commodity?

See also:
Litigation
IVF
Clinical trials
Human Tissue
Regulation