As of November 30, 2021, a number of retaliatory measures have been suspended by the European Commission with regard to certain products originating in the US, based on Implementing Regulation (EU) 2021/2083. These measures were initially introduced on June 20, 2018, in response to US import tariffs on steel and aluminium originating from the EU. The US has meanwhile announced on October 31, 2021 that it will lift these measures under tariff rate quotas effective as of January 1, 2022.
On 30 November 2021, the FCA published PS21/20 on reforms to UK MiFID’s conduct and organisational requirements, setting out changes to the research rules and, in a move that will no doubt be welcomed by market participants, the removal of the best execution reporting in RTS 27 and RTS 28.
The European Commission has sent a letter to the European Parliament and the Council of the EU announcing a delay to the date of application of regulatory technical standards (RTS) under the Sustainable Finance Disclosure Regulation (SFDR). The Commission has now deferred implementation of the SFDR RTS to 1 January 2023.
This HR alert features the following: Polish Deal and employment law, Whistleblowers, Significant changes to immigration laws, Opinion of labour inspection on vaccination of employees, New regulations concerning work-life balance.
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.
On 4 November 2021, the Council of Ministers approved the Competition Bill for 2021 (“Competition Bill”), to be submitted to the Parliament for its examination. The provisions of the Competition Bill affect various sectors, including the healthcare one. In this regard, the most important innovations are those concerning (i) medicines for which the pricing and reimbursement procedure is still pending; (ii) the reimbursement of generic drugs; (iii) the distribution of medicines; and (iv) the production of blood-derivative drugs.
The heads of the Social Democratic Party, the Green Party and the Free Democratic Party presented the coalition agreement of the newly elected German federal government on Wednesday, 24 November 2021. One focus lies on the healthcare and life sciences sector. From driving forward the digitalization of the healthcare market, ensuring the sufficient supply of medicinal products and vaccines, and more restrictions on the prices of medicinal products, to strengthening pharmacies in underserved areas and legalizing recreational cannabis, the new government has set itself a substantive health agenda for the next four years.
The UK Office for Product Safety and Standards (OPSS) has published its response to the recent call for evidence on product safety in the UK (“Response”). In line with the government’s aim to capitalise on Brexit opportunities, the Response emphasises that the UK now has a genuine opportunity to “think boldly” about how to regulate product safety. One concern that is not addressed in detail in the Response is the risk that divergence from the EU product safety and regulatory regime could actually make the UK less attractive for business and in fact discourage innovation within the UK.
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 connection with the opening of the first window for the presentation of FinTech projects in order to participate to the FinTech regulatory sandbox, which started on 15 November 2021 and will last until 15 January 2022 , the three Italian supervisory authorities in charge of running the experimentation, the Bank of Italy, the Consob, and the IVASS, issued a set of regulations that implement the administrative procedures required in connection with the admission to the FinTech regulatory sandbox and the other procedural phases of the experimentation.