Last October the Spanish association of pharmaceutical companies “Farmaindustria” approved its new Code of Good Practice for the Pharmaceutical Industry, which replaces and repeals the previous edition of October 2016. The new Code will come into force as of 1 January, 2021. The new Code of Good Practice introduces a number of important new features. As for the text of the Code, the following changes are noteworthy:
On 26 November 2020, the Spanish Official State Bulletin published the Royal Decree 957/2020, of 3 November, regulating observational studies with medicinal products for human use, which will come into effect on 2 January 2021. This royal decree intends to ease the administrative procedures applicable to observational studies in light of recently adopted instruments at EU level (with the European Medicines Agency-approved guidance on post-authorization efficacy studies) and Spanish level (with the enactment of Royal Decree 1090/2015 on clinical trials with medicinal products, which introduced the legal concept of observational study). Observational studies are an essential tool to gather personal health data on conditions for use, safety and effectiveness of medicinal products, and to ultimately enhance clinical practice in the interest of patients.
Spain has published the Law transposing Directive DAC 6, which will come into force on 31 December. However, in line with EU legislation, it provides for a transitional regime for arrangements for which the first stage of implementation took place between 25 June 2018 and 30 June 2020. In addition, it also applies to cross-border arrangements that have been subject to the obligation (not just to implementation) from 1 July 2020.
Implementing legislation is yet to be published, but it is expected soon, when a number of administrative reports on these rules are finalized.
The pandemic has impacted our lives in many ways, but for many of us, one of the most affected areas has certainly been work. COVID-19 has indeed led to an unprecedented need and demand for remote working. In recent months, many people have been forced or have chosen to work…
The recent publication of Circular 2/2020, of the National Securities Market Commission (“CNMV”) on the advertising of investment products and services (“Circular 2/2020”) on November 13, 2020 includes new rules in terms of advertising of investment products, adding clarifications that go beyond the MiFID package. These new rules affect not only Spanish entities but also foreign financial institutions providing services in Spain under freedom to provide services or right of establishment, including branches and agents.
In brief The Spanish government has presented two bills to Congress, under which it will introduce rises in…
Baker McKenzie’s VAT/Indirect Tax Practice presented “e-Commerce”, on 28 October 2020. This was the seventh presentation in the International VAT Conference Webinar Series, a global webinar series designed for VAT specialists from all industry sectors that aims to discuss the latest developing trends and hot topics in the VAT/goods and services tax (GST) and customs arena.
Today, the Digital Services Tax Act (“the new tax”) was published in Spain’s Official State Gazette and it will enter into force on 16 January 2021. Under this law, digital services for online advertising, online intermediation and data transfers will be subject to taxation in Spain as of 2021.
Royal Decrees 901/2020 and 902/2020, both dated 13 October and published in the Spanish State Gazette (“BOE”) on 14 October, are basically aimed at the regulatory implementation of the new provisions on equality plans, transparency and equal pay contained in Royal Decree Law 6/2019, dated 1 March, on urgent measures to ensure equal treatment and opportunities for women and men in employment and occupation. These two decrees complement each other.
The new regulations are a product of the agreement reached by the Ministry of Labour and Social Economy, the Ministry of Equality and the most representative national trade unions, “Comisiones Obreras” and “Unión General de Trabajadores”.
The impending end, on 30 September, of temporary redundancy schemes (ERTEs) based on COVID-19 force majeure as well as the support measures for these schemes prompted the government to pass, in extremis, Royal Decree Law 30/2020, of 29 September, on social measures to protect employment, pursuant to which a range of measures are adopted to ensure that existing ERTEs are extended and new ones approved if circumstances justify them. The regulation is based on Social Agreement to Protect Employment III, which was reached by the government, trade unions and companies. It will enter into force on 30 September 2020.