Product development and clinical trials
- 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.
Market Access, price and reimbursement
- 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.
- Provided advice on claw-back payments.
- 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.
Information, promotion and advertising
- 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.
- Administrative and court appeals against specific clauses and/or technical specifications in invitations to tender; and against award decisions.
- Filing and defending complaints on abuse of dominance before the Spanish Competition Authority.
- Design and advice on the implementation of controlled distribution systems.
- Advice on complex commercial policies involving bundling, multi-product discounts and other special dealings with hospitals, pharmacies or wholesalers.
- 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 due diligence in connection with the acquisition of a medical device company in Spain.
- Handle legal matters related to investment in several start-up life sciences companies in Barcelona.
- Advice on the negotiation of SPA’s and APA’s of one large manufacturing plant in Spain and of a US generic portfolio.
- Secretariat of the Board of Directors for various companies in Spain.
- Successful representation of companies in various cases involving claims for damages allegedly caused by medicines or medical devices.
Litigation and arbitration
- Lead counsel in unfair competition cases involving medicines and also in some case involving cosmetics.
- Actions for breach of supply or manufacturing agreements including claims for damages.
- Acted as expert witness in international arbitration on termination of a license agreement.
- Design and implement legal defence strategy in cases where market exclusivity rights were at stake.