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).
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.