Europe Archives - HEALTH & LIFE SCIENCES NEWS

EU Parallel Trade Permit: Who Has Burden of Proof that Plant Protection Products and Biocides Are Identical?

by Sabine Naugès | Feb 10, 2021 | International Health, Life Sciences

On 15 December 2020, the French administrative court specified who bears the responsibility to prove that two plant protection products are deemed identical, even in their packaging boxes, in the context of submitting an extension of a parallel trade permit.

Gritche, a French cooperative company specialised in the wholesale of chemical products, has been entitled to a parallel trade permit since 13 December 2014. The permit allows it to import a wheat and barley fungicide called “Tipi” from the United Kingdom. On 27 June 2017, the company filed an application for an extension to the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) in order to be able to import Tipi from Hungary. The product to be imported under the name “Tipi” holds a marketing authorisation on the Hungarian market under the name “D.” granted to Syngenta AD. Gritche considered that this product D. (which would be imported from Hungary under the Tipi name) was identical to the fungicide D. that Syngenta France SAS is allowed to sell on the French market.

On 31 July 2018, the ANSES reached its conclusions regarding the extension request for Tipi’s trade permit. The ANSES estimated that the active ingredients found in the Hungarian product D. and the one authorised in France under the reference D. had the same origin, and that both products’ composition was identical. However, the ANSES stated that the information at its disposal did not make it possible to ascertain whether the packaging was identical. Thus, [...]

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Lawsuits Don’t Make Vaccines… and Other Lessons from AstraZeneca’s Agreement with the EU Commission

by Katya Ascher | Feb 4, 2021 | International Health

Key Take-Away: To avoid ambiguity, parties drafting manufacture and supply agreements should explicitly set out the factors that they deem relevant in assessing a party’s efforts. The manufacturing party may wish to explicitly mention its commitments to other purchasers and expected technical difficulties. This is particularly true in the field of biotechnology where problems in development and early stages of production are common

Vaccines are finally offering hope that the COVID-19 pandemic, which has claimed millions of lives and bulldozed the way we lived “before,” will come to a halt. However, even as the efficacy data is reported and companies obtain regulatory approval, there is another hurdle: global demand far outstrips production capacity.

In this febrile context, AstraZeneca has announced that due to production problems at a Belgian site, it will not deliver to EU member states the expected number of doses of its vaccine, which was granted a conditional marketing authorization in the EU on January 29, 2021. To bolster its contention that AstraZeneca is in violation of its obligation to supply the scheduled doses of vaccines, the EU Commission published a redacted version of the Advance Purchase Agreement for the Production, Purchase and Supply of a COVID-19 Vaccine in the European Union (the APA), which the Commission negotiated and signed on behalf of Member States on August 27, 2020.

What does the agreement say about AstraZeneca’s obligations to supply the vaccines? And what lessons can be gleaned for those negotiating manufacturing and supply agreements in the field?

European Healthcare Innovation & Investment in a Post-Pandemic World

by McDermott Will & Emery | Jul 6, 2020 | Digital Health, Health M&A, Health Private Equity, Hospitals & Health Systems, International Health

As part of McDermott’s HPE Europe 2020: Where Do the Opportunities Exist for Investment in the Healthcare Sector? webinar, McDermott London Managing Partner Hamid Yunis moderated a panel of industry experts including; Dr. Michelle Tempest of Candesic, Dr. Joanne Hackett of IZY Capital, Dr. Charles Niehaus and Professor Karol Sikora of Rutherford Cancer Centres, who collectively shared their perspectives on healthcare innovation and investment in a post-pandemic world.

The panelists agreed that COVID-19 has served as a catalyst for change and which has revealed important prospects for the future.

“There has been this zest for change which we’ve been talking about for a long period of time, and this has finally been that breakthrough,” said Dr. Tempest. “Both the professionals and the consumers have suddenly woken up to this new dawn.”

“What I’ve actually seen in the past couple of months is a lot of innovation that we were really wanting to accelerate are now actually happening,” agreed Dr. Hackett. “And it’s because we’re finally able to look to the future and think about future proofing to make sure that our healthcare system is actually going to deliver. I see positivity.”

Dr. Niehaus emphasized that, the real opportunity at the moment is to take the technologies many people were resistant to pre-COVID now acceptable, and use the shift as a “springboard to actually move forward.”

“We struggle with the cumbersome nature of a nationalized system that doesn’t really encourage entrepreneurism,” Professor Sikora cautioned. “The entrepreneurial skills are there — in [...]

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