Recent Cases

Negotiation and drafting of agreements for the co-development of products in early stages (including cases prior to proof of concept).
Advise on clinical trial agreements entered into between US or EU companies and Spanish sites.

Challenge of marketing authorizations granted to generic/hybrid products in contravention of EU and Spanish legislation on Regulatory data protection.
Advice on the rules and procedures related to various products in Spain including advanced therapy medicines but also medical devices, food supplements, cosmetics, and other health products.

Design and implementation of early access programs.
Advise in price and reimbursement negotiations in complex cases (risk sharing schemes, value-based payments, caps on public expenditure, etc.)
Administrative and court appeals against decisions denying reimbursement or imposing a price reduction.
Challenge rulings regarding the publication of confidential information related to the price of medicines.
Allegations and appeals against reference price orders.

Negotiation of license, co-marketing and co-promotion agreements for various products.
Advise in connection with agreements to manufacture active ingredients and finished drug products.

Legal approval of informative and promotional materials and activities.
Manage litigation under the procedures of the Spanish Code of Practice or in other forums (cases involving the contents of promotional materials, hospitality offered to healthcare professionals or other related matters).

Definition and implementation of compliance tools for various companies, including risk assessment, review of internal SOP’s and participation in Compliance Committees.
Handling investigations on compliance related matters, providing support together with employment and criminal law counsel if needed.

Design of innovative public procurement operations (‘Beyond the pill’) through collaboration agreements or other instruments.
Administrative and court appeals against specific clauses and/or technical specifications in invitations to tender; and against award decisions.

Advice on complex commercial policies (bundling, multi-product discounts and other special agreements with hospitals, pharmacies or wholesalers).
Design and advice on the implementation of controlled distribution systems.
Management of cases involving abuse of dominant position before the Spanish Competition Authority.

Advice on the implementation in Spain of various asset deal transactions involving proprietary products.
Negotiate and draft Joint Venture Agreements for the development of new products and for initiating novel healthcare services.
Conduct regulatory due diligence processes.
Handle legal matters related to investment in start-up life sciences companies.

Successful representation of companies in various cases involving claims for damages allegedly caused by medicines or medical devices.

Advice in unfair competition cases involving medicinal products and cosmetics.
Actions for breach of supply or manufacturing agreements including claims for damages.
Design and implementation of legal defense strategy to protect market exclusivity rights.