The Spanish Agency for Medicinal Products and Medical Devices has launched a new application with the aim of facilitating the registration and improving the communication of biocidal products and of personal care products, as well as regarding facilities that manufacture, import and store biocidal products within the Spanish territory.
On 23 February 2022, the European Commission gave the green light to the proposal for a Directive of the European Parliament and of the Council on Corporate Sustainability Due Diligence and amending Directive (EU) 2019/1937. The Proposal aims to promote sustainable business behavior with regard to supply chains, in particular activities affecting human rights and the environment. To this end, the Proposal introduces a legal obligation to conduct due diligence in the field of human rights and the environment.
On 4 March 2022, the Government approved the Draft Law on the protection of persons who report infringements of regulations and the fight against corruption, aimed at transposing Directive (EU) 2019/1937 on whistleblowers’ protection.
The Spanish Data Protection Authority has recently approved the first industry code of conduct under the General Data Protection Regulation. This industry code has been promoted by Farmaindustria and it governs the processing of personal data in the field of clinical trials and other clinical research and of pharmacovigilance, when they are conducted in Spain.
On 29 December 2021, the new Royal Decree 1157/2021 of 28 December, regulating industrially manufactured veterinary medicinal products (“Royal Decree 1157/2021”), was published in the Official State Gazette. This regulation replaces the existing Royal Decree 1246/2008 of 18 July 2008, regulating the procedure for the authorization, registration and pharmacovigilance of industrially manufactured veterinary medicinal products and also complements Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (“Regulation 2019/6”). Both Regulation 2019/6 and Royal Decree 1157/2021 will enter into force on 28 January 2022.
Law 16/2021 of December 14 was published on December 15, which modifies Law 12/2013, of August 2, on measures to improve the functioning of the food chain. This new reform intends to respond to the continuous claims of farmers in the agricultural and food sector, taking advantage of the framework of the transposition of the Spanish legal system of Directive (EU) 2019/633 of the European Parliament and of the Council, of April 17, 2019, related to unfair business practices in relationships between companies in the agricultural and food supply chain.
As every year since the creation of the reference price system back in 2014, the Spanish Ministry of Health published the new Reference Price Order Order SND/1308/2021 (“Order”) on 29 November 2021. The reference price system consists of the annual revision of the maximum price at which medicinal products included in the National Health System portfolio are financed. Our team already analyzed the draft Order published on 14 July 2021, and the final text barely differs from the draft.
In April, Royal Decree-Law 7 of 27 April 2021 was passed. It introduced major amendments to Royal Legislative Decree 1 of 16 November 2007, approving the revised text of the General Consumer and User Protection Act and other supplementary acts, which we analysed in our May newsletter.
Last June, the Superior Court of Justice of the Basque Country delivered a decision with wide repercussion with regards to advertising of medicinal products by pharmaceutical companies. The decision ruled on an appeal filed by Farmaindustria (the Spanish trade association bringing together innovative pharmaceutical companies) against a regional Order regulating the advertising of pharmaceutical products through medical sales representatives in the context of the Basque Health System.
17 December 2021 is the deadline for all Member States to transpose the new Whistleblower Protection Directive 2019/1937, which obliges businesses with over 50 employees to have a reporting channel. It should be noted that the aim of these new regulations is to exploit the potential for whistleblower protection to strengthen enforcement and set standards for strong protection against any reprisals.