Pharmaceutical companies

On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act.  The Sunshine Act entered into force on 26 June 2022.  However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing

In collaboration with Corporate Law Group, New Delhi, India 

On December 16, 2021, India proposed amendments to the Biological Diversity Act, 2002 (the “BDA”) by introducing the Biological Diversity (Amendment) Bill, 2021 (the “Bill”).  The process to amend the BDA was undertaken in response to long-standing complaints by stakeholders in the Indian systems of medicine, seeds, and research sectors, as well as industry, that existing access and benefit-sharing (“ABS”) processes in relation to Indian biological resources are too burdensome.

The Bill has several objectives.  It seeks to attract foreign investment in Indian biological resources, to fast-track research, patent application processes, and transfer of research results, and to decriminalize non-compliance.  The Bill also seeks to further the conservation of biological resources in line with objectives of the Convention on Biological Diversity (“CBD”) and Nagoya Protocol to the CBD, to encourage cultivation of medicinal plants, and to support the Indian system of medicines.

The Bill’s proposed amendments are extensive and touch on many different aspects of ABS, but focus mainly on access and access procedures.  In this blog, we present the key proposed amendments, as well as next steps in the process for the adoption of the Bill.

Continue Reading India To Amend Its Biodiversity Rules

From 25 to 29 January 2022, the 150th session of the World Health Organization’s (“WHO”) Executive Board (“EB”) took place in Geneva, Switzerland.  Two years into the COVID-19 pandemic, a central theme for this session was the management of global health emergencies.  This post briefly outlines the main take-aways for pharmaceutical companies.

Continue Reading Key Take-aways from the 150th Session of the WHO Executive Board

On 20 January 2022, the National Institute for Health and Care Excellence (NICE) announced major changes to the processes and methods by which it assesses the cost-effectiveness of medicines and other health technologies.

NICE is an independent expert body tasked with appraising the cost-effectiveness of medicines and recommending whether a product should be funded

Following the federal election in September 2021, Germany will soon be led by a new three-party coalition, the so-called “traffic light coalition”, composed of the Social Democratic Party (SPD), the Liberal Democrats (FDP) and the Green Party (Die Grünen). This new federal government led by the new chancellor Olaf

Between 29 November and 1 December 2021, all member states of the World Health Organization (WHO) will convene for an extraordinary session of the World Health Assembly (WHA).  There is only one agenda item: whether or not to commence negotiations towards a legally binding, global instrument on pandemic preparedness and response.  Since it was

On 1 July 2021, the new French rules on early access to unauthorized medicinal products and off-label use of authorized medicinal products entered into force.  The rules were introduced by the Social Security Financing Law for 2021 (LOI n° 2020-1576 du 14 décembre 2020 de financement de la sécurité sociale pour 2021 or “LFSS 2021”, available here).  The reform seeks to simplify existing rules, make early access and off-label use more predictable for all users, and ensure the sustainability of these programs for the public health insurance system.  In this blog, we present an overview of the new rules.

Continue Reading New Early Access and Off-Label Use Rules in France

On May 24, 2021, the World Health Organization (WHO) announced it singed an MoU with Switzerland to host the WHO’s first BioHub Facility, which is part of the new BioHub System first announced at the World Health Assembly in November 2020.

The stated purpose of the WHO BioHub is to set up a system that guarantees the timely sharing of biological material (e.g., clinical samples, specimens, isolates, cultures) for emerging pathogens, so as to ensure their faster identification and characterization and enable risk assessments and the rapid development of countermeasures (e.g., vaccines, diagnostics and therapeutics).

Continue Reading WHO Launches Global BioHub for Pathogen Sharing

On 6 May 2021, the European Commission published its “EU Strategy on COVID-19 Therapeutics” (the “Strategy”).  With the vaccination programme now under way, the EU is shifting focus towards the development, approval and procurement of COVID-19 therapeutic products.  The Commission intends to build on the experience from the EU vaccines strategy.  In particular, the aim is to have three new therapeutics available by October 2021 and possibly two further products by the end of the year.

The Strategy touches on a number of key areas for both biotechnology and pharmaceutical companies operating in the space:
Continue Reading European Commission outlines Strategy on COVID-19 Therapeutics

On March 4, 2021, Brazil deposited with the United Nations its ratification of the Nagoya Protocol (“Protocol”) (see here the announcement of Brazil’s Ministry of Foreign Affairs).  This represents Brazil’s formal commitment to be bound by the Protocol.

On August 6, 2020, the Brazilian Senate passed a Decree that ratifies the Nagoya Protocol. The Protocol complements Brazil’s existing access and benefit sharing rules relating to Brazil’s genetic heritage and associated traditional knowledge (“ABS Framework”).  One important effect of this ratification is that other countries parties to the Protocol will have to ensure that users of Brazilian genetic heritage and associated traditional knowledge comply with the Brazilian ABS Framework.  However, the inverse is also true.  Brazil will need to ensure that Brazilian users of foreign genetic heritage and associated traditional knowledge comply with the access and benefit sharing regime of the country of origin.
Continue Reading Brazil Ratifies the Nagoya Protocol