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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 March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.

As a consequence of Spain’s late implementation of the 5 AML Directive, the Registry of Crypto Exchanges and Custodian Wallet Providers at the Bank of Spain has only been recently activated. Since the end of October 2021, the procedure together with the necessary forms are now available at the Bank of Spain’s website to apply for registration as Exchange Providers of Virtual Currency into Fiat and Electronic Wallets Service Custodians, as provided for in the Spanish Act 10/2010, dated 28 April, on anti-money laundering and terrorism financing.

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.

Please join us for upcoming webinars on important developments in the Consumer Goods & Retail industry. Please note that the webinar series will be held in German only

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.

On 12 August 2021, the Spanish Agency of Medicinal Products and Medical Devices published a briefing note on the new regulatory framework applicable to antiseptics intended for the disinfection of the surgical site prior to surgery or to the injection point. Said products had been regarded by the Spanish regulator as biocidal products until the publication of a Resolution dated 2 June 2021 which reclassified them as medicinal products.