Healthcare
The healthcare and life sciences sector is going through a decisive moment in the process to define itself.
Insufficient public resources, an ageing population, the need to ensure an optimum level of health and wellbeing for citizens and the challenges of globalisation and digitalisation are some of the issues that determine such process.
The regulation of this sector and of the problems that it entails is now a critical tool that no public authority can afford to be without. The quality and regulation of healthcare have become vitally important matters, as well as biotech and smart health solutions, which offer new and interesting potential for growth, without forgetting the advances made in the personalisation of treatments as a result of developments in diagnostics and genetic editing.
At Ramón and Cajal we are aware of the importance of this phenomenon and have therefore been focusing our efforts on the service that we provide to our clients in these areas.
We provide advice to our clients in relation to the construction, financing and operation of healthcare and social health care infrastructure, equipment and services, as well as regarding the management of healthcare and social health care centres, to give only a few examples.
Within the area of healthcare, pharmaceuticals play a hugely important role.
The activities of production, wholesale distribution and retail sale or dispensing of medicinal products and other self-care health products are strictly regulated by the public authorities, which not only establish the requirements for such process but constitute law enforcement agents to ensure the adequate protection of citizens’ health and the best protection of the underlying public interest.
It is therefore the public authorities that authorise the marketing of medicinal products and medical devices and that decide before they are placed on the market whether or not they should be included as products offered by the National Health System, establishing, where applicable, the reimbursement price that should be paid by the Regional Health Systems through the relevant professional bodies.
The health authorities have also recently been controlling the prices, in principle market-based, of medicinal products excluded from the products offered by the National Health System.
Moreover, in recent times the so-called self-care health sector (which includes non-prescribed medicines, medical devices, food supplements, cosmetics, homeopathic medicines, biocidal products or plant-based medicines, among other products) is seeing a surge in development, as it contributes to reducing the costs for the Public Health System and to making citizens’ lives easier.
We are able to provide advice to our clients, normally large companies operating in the healthcare sector, in all these stages of a product’s life and in some others (such as online advertising or selling).
Our team
At Ramón and Cajal Abogados we have extensive experience in advising in regulatory matters in relation to healthcare and pharmaceuticals and our team of highly experienced lawyers are able to provide first class legal support and advice regarding any legal matters that may arise for the main operators in the sector in their relations with the health authorities.
Our team is able to draw on the expertise of lawyers who have worked for a large part of their career in the public sector and who have excellent relations with the public authorities and in particular with the Spanish Ministry of Health, the Spanish Medicinal Products and Medical Devices Agency (Agencia Española de Medicamentos y Productos Sanitarios) and other regulatory bodies.
Our Experience
- We advise companies and public and private organisations regarding the construction, financing and operation of healthcare and social health care infrastructure and equipment.
- We advise companies in the sector regarding the management of healthcare and social health care centres, such as care homes, nursing homes or day centres, among others.
- We advise in the tender and procurement process for certain specific services of the sector (ambulance or air ambulance helicopter services, home treatments for dialysis, oxygen therapy, telemedicine, etc.).
- We advise public authorities and public sector bodies in the drafting of legislative texts and proposals in relation to health.
- We regularly advise laboratories who are intending to market medicinal products or medical devices or modify authorisations, in the clearance procedures conducted with the Spanish Medicinal Products and Medical Devices Agency or with the EMA. Our advice is provided both to manufacturers of “innovative” and generic or “OTC” medicinal products.
- We also advise major companies in the processes for including medicinal products as one of the products offered by the National Health System and for establishing their reimbursement price.
- We advise major pharmaceutical companies in the development and implementation of their websites for the sale and promotion of their products (non-prescribed medicines and other self-care health products).
- We advise the most important business associations and companies of the sector regarding the application of Codes of Professional Conduct and other self-regulatory instruments.
- We provide advice to the Spanish Association of Generic Medicines (Asociación Española de Medicamentos Genéricos or AESEG) regarding any matter relating to pharmaceuticals.
- We provide ongoing advice to the association of producers of OTC medicinal products and other self-care health products regarding any matter relating to their activities in the area of pharmaceuticals or self-care health products (ANEFP).
- We advise the Spanish Association of Self-Care Health Products (Asociación Nacional para el Autocuidado de la Salud) in the process for applying for and being granted the “ANEFP Seal”.
- We have participated actively in the drafting of the “National Health System Guide for the public advertising of medicines for human use”, approved by the Spanish Ministry of Health, ANEFP and AUTOCONTROL (Spanish Association for Advertising Self-Regulation) for non-prescribed medicines.
- We participate annually in defending and providing advice regarding the interests of major pharmaceutical companies and business associations in the process for applying for and enforcing the successive “Reference Price Orders”.
- We act as defence counsel in payment claims in administrative and court proceedings regarding the supply of medicines to public and private hospitals.
- We advise, represent and defend our clients in claims for financial liability on the grounds of medical errors and errors in the operation of the health services, both public and private.
- We advise in a wide range of pharmaceutical matters relating to the distribution of medicinal products, discounts and reductions, traceability, “parallel trade”, etc.