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On 14 July 2022, the European Commission published a proposal for a Regulation on the safety and quality of substances of human origin (SoHO) intended for human application. When adopted, the proposed Regulation will repeal and replace the currently applicable Directive 2002/98/EC on blood (the Blood Directive) and Directive 2004/23/EC on tissues and cells (the Tissue and Cells Directive), with the aim of reforming and modernising the existing EU legislation. The proposal sets out requirements and standards for the safety and quality of blood, tissues, and cells (BTC), as well as other SoHOs, through a single instrument that will apply in all EU Member States in a (hopefully) harmonised manner.

This will be a major development for life sciences companies operating in the EU, including companies developing advanced therapy medicinal products (ATMPs, such as cell and gene therapies) manufactured from or using SoHOs. The Regulation will apply from donation to human application, unless the SoHOs are used in the manufacture of medicinal products or medical devices, in which case the Regulation will apply to donation, collection and testing of the substances only. A public consultation is open until 8 September 2022, and the proposal will also be discussed by the Council and the European Parliament. Once the final text is agreed and adopted, it will come into force, with the proposal setting out a 2-year or 3-year transition period depending on the provision.…

Continue Reading EU Commission adopts Proposal for a Regulation on substances of human origin

As we have previously reported, under the Northern Ireland Protocol of the Withdrawal Agreement between the EU and UK, Northern Ireland (“NI”) has continued to follow the EU rules after the end of the transitional period. In contrast, Great Britain (“GB”) now has a freestanding independent regulatory regime. This means that there are two sets of rules that apply in the UK, and this has led to difficulties with medicines, and other products, moving from GB to NI (the route by which the majority of products reach the market in NI).

In December 2020, the European Commission published a notice that allowed certain flexibilities to be in place through 2021 to ensure there were no medicine shortages in NI (as well as other territories historically dependent on medicines supply through GB). As 2021 concluded, industry – and patients – had been concerned that no long-term solution had been found.

After protracted negotiations, on 17 December 2021, the European Commission put forward proposals to ensure the continued undisrupted supply of medicines from GB to NI. The proposals seek to ensure that patients in NI will have access to life-saving medicines at the same time as patients in the rest of the UK. These proposals also allow time to put in place long-term solutions for the supply of products to NI, and time for industry to adapt to future regulatory requirements and changes.

In parallel, legislation changes have been made in the UK, and the MHRA guidance has been, and is being, updated to reflect the proposals, although they are not yet formally adopted by the EU legislative bodies. Further, the MHRA has stated that there is a reporting obligation on industry to notify the MHRA if the flexibilities applicable to NI will not be used.…

Continue Reading Brexit update: Supply of Medicines from Great Britain to Northern Ireland

Earlier this month, the European Commission published an updated version of the 2011 Note on the handling of duplicate marketing authorisation applications for medicinal products (the 2011 Note). Following a long period of consultation and exchange with stakeholders and representatives from the EU Member States, the European Commission has sought to clarify the conditions under which applications for duplicate marketing authorisations will be assessed. In this blog post, we discuss the relevant changes, as well as the implications for the industry.
Continue Reading European Commission publishes updated guidance for duplicate marketing authorisations

On 20 October 2020, “The Human Medicines (Amendment etc) (EU Exit) Regulations 2020” Bill was laid before the UK Parliament (the 2020 Bill). The Bill proposes amendments to various Statutory Instruments that were drafted in 2019 (the 2019 SIs) in anticipation of a “no-deal” Brexit. The 2019 SIs sought to enable the pharmaceutical regime in the UK to function independently of the EU, and for the MHRA to act as a stand-alone regulator of medicinal products placed on the UK market. The 2019 SIs have now been revived so that they are effective beyond the end of the transition period, which expires on 31 December 2020, subject to any agreement that may be reached with the EU about the ongoing relationship between the UK and EU.

The 2020 Bill includes a number of changes to the 2019 SIs, which themselves changed the current Human Medicines Regulations of 2012. However, one area that is of particular interest to the industry is the regulatory data protection (RDP), marketing protection and orphan exclusivity periods that apply to medicinal products authorised in the UK after the transition period. The 2020 Bill changes the position that had previously been set out in the 2019 SIs.
Continue Reading RDP periods in the UK after Brexit

The European Commission has published a proposal for a Regulation reinforcing the European Medicines Agency’s (EMA) role in crisis preparedness and management for medicinal products and medical devices. According to the European Commission, the COVID-19 pandemic demonstrated that the EMA has a limited ability to manage availability issues relating to medicinal products and medical devices and lacks a framework for crisis response. The aim of the proposed Regulation is to set up such a framework which will allow the EU to respond effectively to health emergencies through broader engagement with the relevant stakeholders in a coordinated and timely manner to achieve the over-arching objective of public health protection.
Continue Reading Draft EU Framework for Coordinated Approach to Addressing Emergency Public Health Threats

As part of the strategy to fight COVID-19, the European Commission has proposed a Regulation to facilitate the conduct of clinical trials using medicinal products containing or consisting of Genetically Modified Organisms (GMOs).

The European Commission recognises that the applicable regulatory framework in relation to GMOs is unable to adequately address the challenges created by the pandemic. While some vaccines in development contain attenuated viruses or live vectors, which may fall within the definition of a GMO, there is uncertainty on the interactions between the GMO regulatory framework and the legislation on clinical trials and medicinal products. This is further aggravated by the absence of a common approach by the EU Member States.
Continue Reading The European Commission proposes a Regulation for COVID-19 clinical trials conducted with medicinal products containing or consisting of GMOs

The Neurim CJEU decision of July 2012 has arguably caused an equal amount of excitement and controversy.  On the one hand, it seemed to open the door to supplementary protection certificates (SPCs) for second or further medical uses.  On the other, it seemed to go against a number of previous decisions.  On a strict literal interpretation of Article 3(d)[1] of the SPC Regulation[2], it should not be possible to obtain an SPC for new applications of old active ingredients that had already been the subject of a marketing authorisation.  In Neurim, based on a teleological interpretation to the SPC Regulation, the CJEU held that such an SPC could be validly granted.

A recent Opinion from Advocate General M. Giovanni Pitruzzella in the Santen SPC preliminary reference[3] urges the CJEU to expressly reject the Neurim decision, considering that the mere limitation of its application or marginalisation would not be a satisfactory option.

The facts in Santen

On 3 June 2015, Santen filed an SPC application relying on European Patent No. 057959306 as the basic patent in force (the “basic patent”) and on an EMA marketing authorisation granted on 19 March 2015 for the drug Ikervis (an eye drop emulsion containing the active ingredient ciclosporin used to treat severe keratisis).  The French National Institute of Industrial Property (“INPI”) rejected the application on the ground that a marketing authorisation had been previously issued for the same active ingredient for a medication called Sandimmun (an oral solution with several therapeutic indications including the eye disease uveitis, an inflammation of some or all of the uvea (the middle part of the eye)).

INPI held that the conditions in Neurim had not been satisfied for two reasons:

  • the basic patent was not limited to the severe keratisis indication – the claims included product only claims and claims to numerous other eye diseases; and
  • Santen had not demonstrated that the marketing authorisation constituted a ‘new therapeutic indication’ within the meaning of Neurim (for example, where the mode of action of the active ingredient differs or where the medical field differs).

Santen appealed the decision to the Paris Court of Appeal and it, in turn, decided to stay proceedings referring two preliminary questions to the CJEU.  The first question has asked the CJEU to consider how the concept of “different application” of an old active substance as understood in Neurim should be interpreted and the question provides a range of possible options from strict to broad interpretations.  The second question asks whether, in the context of determining whether the “[SPC application is] within the limits of the protection conferred by the basic patent” as understood in Neurim, the scope of the basic patent should be the same as the marking authorisation relied upon (i.e. it should be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation).

Less than six months after the preliminary reference was made by the Paris Court of Appeal, the CJEU had the opportunity to consider the scope and relevance of the Neurim decision in the Abraxis SPC case[4].  In that case the CJEU did not openly criticise the Neurim decision and, instead, limited its ramifications by referring to it as an “exception to the narrow interpretation of Article 3(d)” which “does not, in any event, refer to cases of new formulations of the product at issue”.…

Continue Reading Santen SPC case: Advocate General Pitruzzella urges CJEU to reject Neurim

On 13 December 2019, the European Medicines Agency (“EMA”) published a Questions and Answers document (“Q&A”) providing guidance on the conduct of comparability exercise for advanced therapy medicinal products (“ATMPs”). The Q&A addresses various regulatory questions that arise in situations in which companies developing or marketing ATMPs introduce changes to the manufacturing process and need to generate related comparability data.

Background

EMA’s experience suggests that changes to the manufacturing of ATMPs are “frequent” and even more so in the development of the medicinal product. These changes need, however, to be introduced in accordance with the Good Manufacturing Practices (“GMP”). Moreover, the changes may require a variation of the marketing authorisation for authorised ATMPs or substantial amendments to the clinical trial protocol for ATMPs used in clinical trials.

In addition, the changes to the manufacturing of the ATMP must be supported by the data generated in a comparability exercise. This exercise should focus on the characteristics of the ATMP prior and after the introduction of the manufacturing change. This is valid for both investigational ATMPs and authorised ATMPs.

The position of the EMA is that changes to the manufacturing of the ATMP should not undermine or impact adversely the quality, efficacy or safety of the medicinal product or the related risk-benefit balance. The objective of the comparability exercise is to facilitate the assessment and demonstration of this.…

Continue Reading EMA Guidance on Comparability Exercise for ATMPs

This is a follow up to our previous posts relating to the European Medicines Agency’s (EMA) various policies on access to documents. This continues to be an area of activity for the EMA and there have been a number of developments that have impacted the EMA’s position. Firstly, Brexit has directly affected one of the main pillars of the transparency activities of the EMA, namely the proactive publication of clinical trial data submitted by pharmaceutical companies in support of certain types of regulatory submissions to the Agency (the EMA’s Policy 0070).

Secondly, while the reactive transparency activities of the EMA relating to access to documents in accordance with Regulation (EC) No 1049/2001 (the EMA’s Policy 0043) have been less affected by Brexit, there may be other challenges for the EMA ahead.…

Continue Reading Latest Developments in the Transparency Activities of the European Medicines Agency

On 3 June 2019, the European Medicines Agency (EMA) launched a public consultation on a draft guideline providing guidance on the quality dossier requirements for Drug-Device Combinations (DDCs) in the context of a marketing authorisation or post-authorisation application.

DDCs are human medicines that include a medical device. The guideline covers those devices that are necessary for the administration, dosing or use of the medicine. They can be integral, co-packaged or referred to in the product information of the medicine but supplied and obtained separately.…

Continue Reading EMA releases draft guidelines on drug-device combinations