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Magda Tovar

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In EU Pharmaceutical Package

Council Clears Path to Trilogue on Pharma Package with Reduced Market Protection and stepped up Access Obligations

by , , , and 7 Mins Read

Political compromise raises questions around feasibility implementation and EU’s innovation edge After nearly two years of negotiations, the Council of the EU has adopted its negotiating position on the proposed revision of the pharmaceutical legislation on 4 June 2025. This milestone reached under the Polish presidency follows intense debate and numerous concessions among Member States. The most divisive issues of access to medicines and incentives for pharmaceutical innovation are likely to remain a balancing act…

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In Medical Devices

US Tariffs and the Life Science industry – an update

by , , and 4 Mins Read

Following our previous post here, we provide an update on the current developments in this area. On April 2, 2025, the US administration announced reciprocal tariffs on all imports into the United States (see here). As it has been widely reported, pharmaceutical products were exempted from these tariffs whereas medical devices were not. Subsequently, on April 9, 2025, the administration announced a 90-day postponement of the reciprocal tariffs for most countries except for China. For…

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In Medical Devices

The Impact of Tariffs on the Life Sciences Industry

by , , and 9 Mins Read

Import tariffs have become the priority trade issue since President Donald Trump took office on January 20, 2025, with a wide variety of measures announced and imposed. These tariffs have the potential to disrupt all industries; however, they pose unique challenges for the life sciences industry, in particular the pharmaceutical and medtech industry, whose products have typically not been subject to customs duty on cross-border movements. We have set out below i) a summary of…

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In Pharmaceuticals & Biotech

Has the European Parliament Missed the Chance to Boost Orphan Drug Development?

by , , and 1 Min Read

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 Commission’s 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 Commission’s proposals for orphan drugs. For further information on this topic please contact Els Janssens, Olha Sviatenka, Magda Tovar and Julia…

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In Healthcare Services

The First Implementing Act of the EU HTA Regulation on Joint Clinical Assessment  Foresees Limited Involvement of Health Technology Developers and Short Timelines

by and 7 Mins Read

In brief The Commission’s Implementing Act on Joint Clinical Assessments for medicines for human use was finally adopted on 23 May 2024. This is the first out of six Implementing Acts for the EU HTA Regulation. With only seven months to go before the HTA Regulation becomes applicable, developers of medicines within the first wave of products subject to the HTA Regulation will need to consider their strategy for EU assessment and its interplay with…

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In Medical Devices

The European Commission launches an investigation into Chinese public procurement of medical devices

by 4 Mins Read

On 24 April 2024, the European Commission announced the launch of a formal investigation into the measures put in place and practices followed by China in its public procurement of medical devices. The announcement responds to the Commission’s belief that these measures and practices favour domestic Chinese suppliers whilst putting EU companies at a clear disadvantage. The investigation will be carried out under the EU’s International Procurement Instrument (IPI), a trade tool that aims to…

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In Digital Health

Clinical Trials Agreements – How Much Flexibility is there for Sponsors Across the Globe?

by , , , and 2 Mins Read

Baker McKenzie has recently conducted a survey across over 100 jurisdictions, asking our Healthcare & Life Sciences global network of specialists to compare the degree of flexibility clinical trial sponsors have to negotiate with sites in clinical trial agreements. We have received input from our healthcare regulatory experts in 105 jurisdictions and are therefore able to build a global picture of how the flexibility afforded to sponsors varies from market to market. The results are…

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In Digital Health

EU AI Act Approved by the EP – Update and Insight Into Other AI Industry Specific Developments

by , and 3 Mins Read

EU AI Act On 13 March, the European Parliament approved the EU AI Act. The link to the adopted text is available here. The next step is Council’s adoption, expected next month. Following the Council’s sign off, the final text will be prepared for publication in the Official Journal and will enter into force 20 days afterwards. Once adopted, the Act will become applicable in a gradual manner. For products that are already required to…

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In Pharmaceuticals & Biotech

Agreement Reached on EU Substances of Human Origin (SoHO) Regulation

by , and 3 Mins Read

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 ‘blood’, ‘tissue’ or ‘cell’ to avoid that certain groups of donors or recipients are left…

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In EU Pharmaceutical Package

EU Pharma Package: EP Rapporteurs Have Opposing Views on the New Pharmaceutical Directive and Regulation

by , , and 9 Mins Read

The European Parliament (EP) has published two draft reports on the Commission’s proposals for a new Pharmaceutical Regulation and Directive. The reports have been drafted by the MEPs assigned as rapporteurs for the Directive (Pernille Weiss, EPP) and for the Regulation (Tiemo Wölken, S&D) and will be debated at the Committee for the Environment, Public Health and Food Safety (ENVI) later this month or beginning of November. The report on the Directive is favourable to…

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