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Montserrat Llopart

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Montserrat Llopart has extensive experience in the areas of pharmaceutical and medical devices law, as well as competition, acquisitions and commercial law. She is currently the coordinator of the healthcare practice in the Baker McKenzie Barcelona office. Montserrat is also the chairman of the Healthcare Law Steering Committee of the Firm in Europe, Middle East and Africa (EMEA). Montserrat was awarded "Best Lawyer of the Year 2018" for Healthcare in Spain by the American group Best Lawyers. She was also named by Iberian Lawyers as one of the most inspirational female lawyers in 2018 in Spain and Portugal (InspiraLaw Top 50 Women List).

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.

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.

On 30 July 2021, the Official Journal of the European Union published the Commission Implementing Regulation (EU) 2021/1248 of 29 of July 2021, as regards measures on good distribution practice for veterinary medicinal products in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (“Implementing Regulation”). The Implementing Regulation applies to holders of manufacturing authorizations performing wholesale distribution of veterinary medicinal products covered by that manufacturing authorization, and to holders of a wholesale distribution authorization, including those established or operating under specific customs regimes, such as free zones or customs warehouses.

The Spanish association of pharmaceutical companies (“Farmaindustria”) has updated the Code of Good Practice for the Pharmaceutical Industry (“Code”), which came into force last 1 January 2021. This amendment is mainly aimed to introduce to section 14.2 of the Code a new definition and regulation for non-interventional studies in accordance with the provisions of the new Royal Decree 957/2020, of 3 November, which regulates non-interventional studies with medicines for human use (“RD 957/2020”). The RD 957/2020 came into force last 2 January 2021.

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.