Pharmaceutical companies can breathe a sigh of relief following the European Court of Justiceâs recent ruling in the Novo Nordisk A/S case (C-248/23 ). This decision marks the third time the ECJ has softened the rules around deducting pharmaceutical subsidies from the VAT base. Previously, in the German and Hungarian Boehringer cases (C-462/16 and C-717/19), the ECJ allowed subsidies to be deducted if paid to private insurers and later extended this to public insurers under…
The Indian pharmaceutical sector is currently undergoing significant regulatory changes. All stakeholders, including Indian companies, prospective investors, pharma retailers and HCPs should be closely monitoring these changes to ensure they remain compliant whilst capitalizing on opportunities. The Indian government has lately introduced new guidelines and standards that could impact various aspects of the industry, from patent filings to marketing practices. Here are four areas critical areas to watch: 1. Patent (Amendment) Rules 2024: Beware shorter…
The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commissionâs original proposals on orphan exclusivity periods, we argue in this piece for the Pink Sheet (paywall). This article is a continuation from our previous analysis on the Commissionâs proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…
Bipartisan legislation advancing in the U.S. Senate and the U.S. House of Representatives known as the âBIOSECURE Actâ (âthe Actâ) has the potential to restrict the ability of biotechnology companies to collaborate with certain Chinese companies without losing the ability to contract with the U.S. government. Following the same model that was used to target Chinese telecommunications companies in the late 2010s, the Act would prohibit federal âexecutive agenciesâ from contracting with or extending loans…
On 10 April 2024 the European Parliament approved the text of the recast Urban Wastewater Treatment Directive. Of particular relevance to pharmaceutical and cosmetic companies, the recast Directive will introduce new extended producer responsibility (“EPR”)[1] obligations in respect of micropollutants from their products that end up in the urban wastewater stream. Background The EU’s Urban Wastewater Treatment Directive (the “Directive”) has been in place since 1991 and aims to protect human health and the environment…
As the pharmaceutical industry adjusts to the further changes the Windsor Framework will bring, there are important changes ahead for parallel import licensing across the UK. The transition from Parallel Distribution Notices (PDNs) to Parallel Import Licences (PLPIs) has introduced new requirements that will impact parallel distributors in Great Britain and Northern Ireland. In Great Britain, PDNs have already been replaced by PLPIs, allowing products to be marketed exclusively within the region. However, with the…
To future-proof its regulatory system, the UAE cabinet has established the Emirates Drug Corporation (EDC) in September 20231. As a new independent regulator, the EDC will replace the Ministry of Health and Prevention (MOHAP) for the regulation of pharmaceuticals and medical devices. Besides medicines and medical devices the EDC will also be responsible for cosmetics, dietary supplements, GMOs, fertilizers, pesticides, agricultural conditioners and plant growth regulators. The EDC will also take over some competences from the Ministry of Climate Change and Environment…
The Corporate Sustainability Due Diligence Directive (“CS3D”), provisionally agreed in December 2023, will create significant behavioural and reporting obligations for many EU and non-EU healthcare and life sciences companies active in the EU, adding an additional layer of compliance and complexity to their already highly intricateglobal value chains. In this first instalment of our new “CS3D Explainer Series”, we provide an overview of scope, key obligations and relevant timeline under the CS3D.
In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the…
On 14 December 2023, Council and the European Parliament reached a major political agreement on the Substances of Human Origin (SoHO) Regulation. This Regulation will replace the Blood Directive and the Tissues and Cells Directive, combining both legal texts into one. In addition, the Regulation will extend its protection to any SoHO regardless of whether it meets the definition of âbloodâ, âtissueâ or âcellâ to avoid that certain groups of donors or recipients are left…