On April 27, 2023 the European Commission (“Commission”) released its proposal to introduce a single procedure for the granting of Supplementary Protection Certificates (“SPCs”) throughout the EU. The changes are intended to complement the new unitary patent procedure that will enter into force on June 1, 2023. The Commission intends the new unitary SPC to
The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”). In this blog, we provide an overview of the potential impact of the Proposal
The existing EU pharmaceutical legislation provides for a number of specific exemptions from the marketing authorisation requirement, including products supplied on a named patient or compassionate use bases; products compounded and dispensed in pharmacies (magistral and officinal formulations) and also for products necessary to respond to public health emergencies. Given that a key policy goal
Tune into the second episode of Covington’s Life Sciences Audiocast, where Sarah Cowlishaw, Ellie Handy, and Léna Beley discuss key developments in the medical device sector in the EU and the UK. Our speakers review the major legal developments for medical devices in the last few years, including the issues surrounding the
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.
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 13 December 2020, Belgium amended its rules regarding compassionate use and medical need programs to confirm that authorized programs can continue to operate after the marketing authorization for the concerned product has been granted but while the decision on reimbursement is still pending.
The Law of 25 March 1964 (“Medicines Law”) regulates the use of medicinal products that have not (yet) received a marketing authorization (“compassionate use”, “CU”) and for off-label use (“medical need”, “MNP”). The Belgian Federal Agency for Medicines and Health Products (“FAMHP”) must grant an authorization to allow the use of medicinal products in a compassionate or medical need context
Continue Reading Belgium Amends Compassionate Use and Medical Need Program Rules to Expand Access