COVID-19: Potential legal impact (latest developments) – Pharma (Spain)

Since our latest note (see here) on the impact of the health crisis caused by COVID-19, this e-bulletin explains the potential ramifications of new regulations that have since been passed, particularly Royal Decree-law 8/2020, of 17 March, on extraordinary measures to tackle the economic and social impact of COVID-19 ("RDL 8/2020").

Pharmaceutical sector

The Spanish Medicines Agency (Agencia Española de Medicamentos y Productos Sanitarios, or AEMPS) has declared that Order SND/233/2020, of 15 March, which establishes certain information obligations in accordance with the provisions of RD 463/2020, applies to Spanish and foreign entities located in Spain that manufacture and/or import any of the products listed in paragraph three of the Order. However, it does not apply to the individuals or entities that are the users of those products, or that use their own production or distribution processes.

• RDL 8/2020 includes measures aimed at bolstering the fight against the disease, some of which apply to this sector in relation to public medicine supply contracts, which are summarised in the public procurement section above.
  In any event, RDL 8/2020 does not apply to medical, pharmaceutical or other services or supply contracts that are linked to the public health crisis caused by COVID-19.
• AEMPS guidelines for the pharmaceutical production and distribution sector in the event of COVID-19 contagion. As the services provided by manufacturers or distributors of medicines and medical devices are mostly essential as they are currently critical to ensure the proper supply of medicines, medical devices and biocides used as skin antiseptics and disinfectants for clinical and surgical areas, AEMPS has published a series of recommended courses of action in the event of COVID-19 contagion in those entities.
  Although the staff working in those entities are not strictly health or medical personnel, as they do not work in a clinical environment where the risk of exposure is greater, AEMPS has issued a number of guidelines to ensure the continuity of the essential activity that they perform.
• Clinical trials. AEMPS has published an informative note (4/2020) on the exceptional measures applicable to clinical trials in the context of COVID-19 infection with the aim of safeguarding, as far as possible, the trial, the safety and welfare of patients and the reliability of trial results. It makes a number of recommendations on scheduled in-person testing patients, patient access to trial medication, scheduled monitoring, and the transfer of patients among clinics. These measures may be adopted without authorisation from AEMPS or from research ethics committees. However, any change to the clinical trial protocols must be reported within four months following the end of the COVID-19 crisis.
• Supply of veterinary medicines. AEMPS has issued a statement that, as the veterinary medicine sector is strategic to protecting the public food supply, protecting health conditions in livestock businesses and preventing the transmission of diseases to people, the continuity of the manufacture, distribution and supply of those medicines must be guaranteed, as well as the movement of people and the transport of products essential for performance of those activities.

To read the complete e-bulletin, here.