The healthcare and life sciences sectors are going through a decisive moment in the process to define themselves. The regulation of these sectors is a requirement that no public body can overlook. 

At Ramón y Cajal we focus all our efforts on ensuring that we provide an optimum service to our clients in these areas, and in particular to the pharmaceutical sector, in anything concerning the authorisation of medicinal products and medical devices and their inclusion in the pharmaceutical products offered by Spanish National Health System, or the establishing of reimbursement prices, among other matters.

We also advise the main companies operating in the self-care health sector (non-prescribed medicines, medical devices, food supplements, cosmetics, homeopathic medicines, biocidal products and plant-based medicines, among other products).

We have a highly-experienced team of lawyers working in this field and have excellent relations with the public authorities and in particular with the Spanish Ministry of Health, the Spanish Medicinal Products and Medicals Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) and other regulatory bodies. 

Our main services in this area are: 

• Drafting of legislative texts and proposals in relation to health. 

• Procedures for authorising the marketing and sale of medicinal products.

• Processes for including medicinal products as one of the pharmaceutical products offered by the Spanish National Health System and for establishing their reimbursement price.

• Assistance in the process for applying for and enforcing the Reference Pricing System (RPS).

• Advertised medicinal products and other self-care health products.

• Notified price procedures for unfunded medicines. 

• Codes of Professional Conduct and other self-regulatory instruments.

• Payment claims in administrative and court proceedings regarding the supply of medicines to public and private hospitals.

• Claims for public services liability on the grounds of medical errors and errors in the operation of health services, both public and private. 

• Wide range of pharmaceutical matters relating to the distribution of medicinal products, discounts and reductions, traceability, “parallel trade”, etc.

• Construction, financing and operation of healthcare and social health care infrastructure and equipment.

• Management of healthcare and social healthcare centres.

• Tender and procurement processes for certain specific services of the sector (ambulance or air ambulance helicopter services, home treatments for dialysis, oxygen therapy, telemedicine, etc.).

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