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The Spanish Ministry of Health has adopted a new draft of the Royal Decree on Industrially Manufactured Veterinary Medicinal Products (“Royal Decree on Industrially Manufactured Veterinary Medicinal Products”). The new draft establishes specific provisions for the application in Spain of Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (“Regulation 2019/6”), which, together with Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, represents the legislative framework adopted in the middle of the European One Health Action Plan against antimicrobial resistance.

On 14 July 2021, the Spanish Ministry for Health, Consumer Affairs and Social Welfare (Ministerio de Sanidad, Consumo y Bienestar SociaI) published the draft of the new Reference Price Order. The ministry must update the reference price of the medicinal products annually. This new draft updates the reference prices set forth in the previous orders, establishes new groups and removes those that do not meet all of the applicable requirements due to supervening causes. To be included in a specific reference group, medicinal products must have the same Level 5 ATC code and an identical administration route. Interested parties have 15 days to allege what they deemed convenient for their best interests. The deadline is 4 August 2021.

On 13 July 2021, the EU Council of Ministers approved the national recovery and resilience plans (RRPs) of 12 Member States. This means that Austria, Belgium, Denmark, France, Germany, Greece, Italy, Latvia, Luxembourg, Portugal, Slovakia and Spain are now able to tap into the EU recovery and resilience funding. This will allow them to start spending the money on projects and reforms for national economic recovery and resilience, as well as the green transition and digital transformation.

Tax Fraud Prevention Act 11/2021, was published on 10 July 2021. This act transposes Council Directive (EU) 2016/1164, dated 12 July 2016 (Laying Down Rules against Tax Avoidance Practices that Directly Affect the Functioning of the Internal Market), which amended various tax laws and gambling regulations. This new Act amends a vast number of regulations and affects almost every aspect of the Spanish tax system (both for companies and individuals, international taxation, indirect taxation, general tax rules…).

The Legal Office of the Spanish Data Protection Agency (the “SDPA”) has issued on 17 June 2021 a legal report addressing various issues related to the processing of data in the context of health research in the form of clinical trials. Specifically, this report analyzes the legal position of the sponsor, the monitor and the healthcare centers in relation to the processing of trial patient data, and in particular of the clinical history.

The new proposed regulation (“Circular”) is aimed at developing the rules, principles and criteria to which crypto-asset advertising will be subject. The Circular defines the type of entities and assets included in its scope and the powers granted to the Spanish financial regulator, the National Securities Market Commission (CNMV), so it can supervise and control the adverting of certain types of crypto assets that have been deemed unregulated products thus far. The deadline for interested parties to reply to the public consultation is 31 August 2021.

The tax challenges of the digital economy may catch historically non-digital companies by surprise as they “go digital.” Baker McKenzie’s Special Report, Digital Revolution: Transfer Pricing on the Global Tax Battlefield provides insight into digital technology trends non-digital businesses are incorporating and the key tax trends companies must actively navigate including industry sector case studies, transfer pricing considerations, multilateral and unilateral measures, transfer pricing audits and dispute resolution.