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In EU Pharmaceutical Package

New German Pharmaceutical Strategy Promises to Bolster Investment and Innovation, Implicitly Questioning the EU Pharmaceutical Review

by 6 Mins Read

On 13 December 2023, the German government published a long-awaited strategy outline of intended upcoming legislative measures to counter both the dwindling significance of Germany as a strong hub for pharmaceutical innovation, and threats to supply chain security. The proposed action items fall into 8 chapters, the most significant of which for pharmaceutical companies are briefly summarised below: 1. Strengthening clinical research; a model clinical trial agreement and centralised ethics committee The government intends to…

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In EU Pharmaceutical Package

Polish HTA and Reimbursement Shake Up Creates Potential Ambiguity For Industry in Face of EU Pharma Package

by 4 Mins Read

In brief 1 November 2023 marked the entry into force of the largest amendment to the Polish Act on the Reimbursement (Amendment) since it came into force in 2012. As reported in this blog, the Commission’s Proposal to reform the EU General Pharmaceutical legislation includes a measure whereby  marketing authorisation holders (MAHs) would be expected to ensure patient access in all the EU Member States within two (or in exceptional cases, three) years as of…

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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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In EU Pharmaceutical Package

The French Government Advances its Pawn in the Battle to Prevent Medicine Shortages and Releases the First List of “Essential” Medicines

by , and 4 Mins Read

On June 13, the French Government released a list of 450 medicines considered “essential” to meet patient priority needs and which require specific measures to ensure their availability. Medicines were selected according to shortage criticality combining frequency of use and severity in case of shortage. The current list is available here but is not set in stone. It is intended to be enriched and updated according to changes in the French population’s needs and the…

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In EU Pharmaceutical Package

Supply Chain Protection: What do the EU Reform Proposals Look Like and do They go Far Enough?

by , and 3 Mins Read

As already well noted on this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation. A key plank of the reforms comprises measures designed to preserve and protect the supply of medicines across the EU, in particular, critical medicines. Although many member states already have mechanisms in their armoury to protect their own supply chains, this reformatory drive to protect supply chains throughout the…

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In EU Pharmaceutical Package

The Future is Green: Eco Measures are Embedded into the EU Reform Proposals

by , and 2 Mins Read

As previously covered in this blog, on 26 April 2023 the European Commission published a set of proposals for the reform of EU pharmaceutical legislation. One of the most significant aspects of the reforms is that measures to protect the environment are core. For the first time, protection of the environment will be brought to the fore of the pharmaceuticals industry, and are embedded and enshrined throughout the package. Our ESG expert within our Brussels…

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In EU Pharmaceutical Package

The EU Pharmaceutical Package From a National Perspective: Member States’ First Reactions

by , , , and 6 Mins Read

The Proposal to revise the EU Pharmaceutical legislation has generated unprecedented levels of attention, not only across the industry but also amongst Member States with some countries already positioning themselves in favour or against some of the measures included in the proposed Regulation and Directives. In this article we review some of these positions, which focus mostly on the incentives regime and on the management of shortages. France In March 2023, a month before the…

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In EU Pharmaceutical Package

Hungarian Pricing and Reimbursement Reforms Aiming to Remove Hurdles to Late Market Access of Innovative Pharmaceuticals

by and 3 Mins Read

In brief Reimbursing medicinal products is critical to ensure that treatments are widely available to patients. This is especially true for innovative products and is expected to become even more important with the EU Pharma reform package. Pricing and reimbursement (P&R) is an area regulated at Member State level, and on average the regulatory approach in Hungary has been on the stricter side for new medicinal products causing delay to market access. However recent legal…

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In EU Pharmaceutical Package

EU Pharma Package: How Significant are the Proposals for Orphan Medicines?

by , and 6 Mins Read

On 26 April 2023 the European Commission published its Proposals to Reform the EU pharmaceutical legislation.[1] We continue our analysis of the Proposals with this focus upon the changes concerning orphan medicines. 1.The current Orphan Regulation (EC) No 141/2000 will be repealed, and the new orphan provisions will be integrated into the general Regulation laying down the EU procedures for the authorisation and supervision of medicines. 2. The orphan designation criteria remain largely unchanged, meaning…

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In EU Pharmaceutical Package

A New Dawn for the EU Pharma Regulatory Regime? The Commission’s Proposal to Revise the EU Pharmaceutical Legislation is Finally Published

by , and 5 Mins Read

Today the European Commission has finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical…

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