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Product Regulation & Liability

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In Antitrust / Competition

Italy: Competition Bill – Provisions concerning the healthcare and pharmaceutical sector

by 2 Mins Read

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.

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In Cybersecurity, Data and Tech

Germany: New government new rules – an overview of the health-related plans of the new German three-party coalition

by 3 Mins Read

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.

In Europe

United Kingdom and European Union: Separate product safety reform initiatives continue with no guarantee of alignment

by , and 9 Mins Read

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.

In Asia-Pacific

China: New Regulatory Requirements for Imported Food Products

by and 8 Mins Read

On 12 April 2021, the General Administration of Customs of China issued Order No. 248, which sets out new requirements for the registration of qualified foreign food producers that are allowed to export food products to China, effective from 1 January 2022. This Order represents a significant move toward tightening up the regulation of foreign made food products imported into China.

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In Cybersecurity, Data and Tech

Life Sciences Business Evolution Series – Report 1: How Digital Transformation and Data Are Shaping Business Models

by , , , , , , , and 2 Mins Read

As digital transformation reshapes business models with different emphases across regions, digitally enabled strategies are helping companies transition from product-only offerings to product-service hybrids, orient to patient mapping, pre-diagnostics solutions and enhancing treatment administration.

In Europe

Italy: Consolidated Law on rare diseases

by 2 Mins Read

On 27 November 2021, Law No. 175/2021 (“Consolidated Law”) was published in the Official Journal. The Consolidated Law’s main objective is the protection of the right to health of those suffering from rare diseases through measures aimed at ensuring the uniform distribution of services and medicines, including orphan drugs, throughout the Italian territory, the surveillance, diagnosis and treatment of rare diseases as well as the support to research activities.

In Europe

Italy: Medical device coordination group: Update of the document on the operating procedures of notified bodies

by 1 Min Read

In October 2021, the Medical Device Coordination Group (MDCG) published the third revision of the MDCG 2019-6 Questions and answers: Requirements relating to notified bodies, which provides clarification on the operating procedures of notified bodies responsible for performing conformity assessment activities under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

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