On 25 November 2021, the European Commission adopted Implementing Regulation (EU) 2021/2071 subjecting vaccines against COVID-19 and active substances used for the manufacture of same to export surveillance for a period of 24 months starting from 1 January. This Regulation will replace the existing regulatory framework requiring vaccine exports to be subject to an authorization by Member States.
Pending the full functionality of the European Database on Medical Devices, the European Commission made available two new modules, to be used on a voluntary basis, for the registration of medical devices by economic operators and for the registration of certificates of conformity by notified bodies.
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.
On 29 November 2021, Legislative Decree No. 179/2021 was published in the Official Journal, introducing the applicable sanctions for violations of Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products. The new sanctions entered into force on 14 December 2021.
Health Technology Assessment is a scientific evidence-based process that allows competent authorities to determine the relative effectiveness of new or existing health technologies. This multidisciplinary process evaluates the medical, social, economic and ethical issues related to the use of a health technology. Health technologies encompass medicines, medical devices, in vitro diagnostic medical devices and medical procedures, as well as measures for disease prevention, diagnosis or treatment.
On 7 December 2021, the FCA published its second consultation on the Consumer Duty, setting out more developed proposals for rules and guidance following feedback from its first consultation. The proposals set out in the first consultation have been mostly carried forward, though the FCA has made some important amendments and clarifications in response to feedback received. For more detail on the first consultation, including background to the introduction of a Consumer Duty.
In response to an Indonesian Trade Security Committee report that shows that local manufacturers are threatened by the increased import of apparel and its accessories, the Ministry of Finance has imposed a safeguard duty on imports of those products. Minister of Finance Regulation Number 142 of 2021 on the Imposition of Safeguard Duty on the Import of Apparel and Its Accessories became effective on 12 November 2021.
On 16 November 2021 a new Coordination Agreement (CA) over Health Control, executed between the Federal Ministry of Health and the State of Baja California (“Baja”), was published on the Federation’s Official Gazette. This new CA has a particular impact over the medical devices industry operating in Baja, improving greatly the regulatory environment.
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.