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.
Baker McKenzie’s Sanctions Blog published the alert titled “Russia imposes a ban on foreign aircraft flights from 36 states” on 1 March 2022. Read the article via the link here. Please also visit our Sanctions Blog for the most recent updates.
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 2 February 2022, the Madrid Regional Council passed the Draft Open Market Bill, which is currently undergoing a parliamentary procedure at the Madrid Assembly and is expected to be passed by June 2022. Once it is passed, it will become enforceable three months after it is published in Madrid’s Official Regional Gazette. The approval of this Draft Bill takes place in a context in which the European Union has urged the Member States to adopt measures to eliminate obstacles to the free movement of goods and services, particularly after the economic and social crisis caused by the COVID-19.
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.
Royal Decree-Law 32/2021 of 28 December 2021 contains the measures agreed on 23 December 2021 within the scope of social dialogue between the Spanish government and the most representative trade unions and business organizations state-wide. This new regulation is the result of a reform process undertaken at the initiative of the government and has basically concluded with significant amendments in three regulatory fields: (i) Temporary employment contracts; (ii) collective bargaining, and (iii) internal flexibility measures or temporary lay-offs.
The Spanish Council of Ministers has passed a preliminary bill that is expected to include additional rules on customer services.
The year has ended with important new developments for companies that contract with the public sector, new developments that have come into force on January 1. Both the State and Catalan’s budgetary laws contain provisions on this matter. Also, as each year, the new thresholds applicable to harmonized contracts have been published.
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.