Supply Shortage

Subscribe to Supply Shortage

On 31 January 2022, Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency (“EMA”) in crisis preparedness and management for medicinal products and medical devices was published in the Official Journal of the EU. This Regulation sets out a stronger role for the EMA in managing public health crises, and aims to formalise the ad-hoc structures and processes that have been used by the EMA during the COVID-19 pandemic. The intention is that these ad hoc process can now serve as a blueprint for a more harmonised EU response to future public health emergencies.

The reinforced role of the EMA is seen as an important development for the European Health Union. It aims to ensure that the EU is better prepared to manage future health crises by tackling shortages of medicines and medical devices more effectively and to develop medical countermeasures to address the threats posed to public health at an early stage and in a harmonised way. As part of this, the Regulation sets out important provisions on monitoring shortages of medicines and devices, and a greater role of the EMA in overseeing medical devices.…

Continue Reading New EU Regulation Reinforcing the Role of the EMA

At the end of 2020, the European Commission set out its vision to build a European Health Union with its announcement of the new pharmaceutical strategy for Europe (the new Strategy). As we discussed in a previous blog, the new Strategy seeks to introduce new policies and ideas, whilst bringing into the spotlight long standing challenges which were exacerbated by the Covid-19 pandemic. The new Strategy puts forward numerous proposals for legislative reforms that are likely to affect the regulation of the entire life cycle of a medicinal product and the regulation of medical devices. As a reminder, the key elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply of medicinal products.

In this post, we focus on the developments in the first half of 2021, including a pilot project launched by the European Medicines Agency (EMA) on market access and the Commission’s Roadmap on revisions to the pharmaceutical legislation.…

Continue Reading Update on the European Commission’s proposed new pharmaceutical strategy

As part of its vision to build a European Health Union, the European Commission announced the new pharmaceutical strategy for Europe (the new Strategy) on 25 November 2020. The new Strategy introduces new policies and ideas but also brings into the spotlight long standing challenges which were recently exacerbated by the coronavirus outbreak. The new Strategy puts forward numerous proposals for legislative reforms that are likely to affect the regulation of the entire life cycle of a medicinal product. Some of these revisions also affect the regulation of medical devices. The main elements of the new Strategy relate to innovation, availability, accessibility, affordability, and supply in relation to medicinal products.

In this post, we focus on the key proposed regulatory changes expected to impact the pharmaceutical industry. The post also discusses the implications of the new Strategy from the EU competition law perspective.

…
Continue Reading European Commission proposes a new pharmaceutical strategy for Europe

On 18 January, a new statutory instrument, the Human Medicines (Amendment) Regulations 2019 (the Amending Regulations), which amend the Human Medicines Regulations 2012,  was laid before Parliament.  These regulations will come into force on 9 February 2019.

The principal purpose of the amendments is to transpose into UK legislation the remaining provisions of Directive 2011/62/EU (the Falsified Medicines Directive), which require two new safety features to appear on the packaging of certain medicinal products, and the associated Commission Delegated Regulation 2016/161/EU (the Delegated Regulation), which sets out the details of these features. However, the Amending Regulations have also introduced an important new provision allowing for “serious shortage protocols” (SSPs) to be put in place for prescription-only medicines (POMs) in certain circumstances, and have extended the types of product containing naloxone (indicated for the treatment of opioid overdose) that drug treatment services may supply in an emergency.…

Continue Reading Amendments to UK Human Medicines Regulations 2012