On 4 May 2020, the European Medicines Agency (EMA) issued a guidance to support development and regulatory approval for treatments and vaccines for COVID-19 with the involvement of the dedicated EMA Pandemic Task Force (COVID-ETF). It sets out the available regulatory pathways to fast-track assessment of both new or repurposed methods of treating or preventing COVID-19.

Background

This guidance is part of EMA’s efforts to support the development and availability of medicinal products for COVID-19 to address this public health emergency. See also EMA’s guidance on clinical management trials (which we have summarised in a prior Advisory)

This latest guidance is based on the existing and established regulatory procedures to accelerate regulatory review and approval with appropriate adaptations  in direct response to COVID-19 pandemic. Continue Reading EMA Guidance on fast-tracking the development and approval of treatments and vaccines for COVID-19

The spread of SARS-CoV-2 has created an urgent need to scale up the production and supply of essential medical equipment, including so-called Rapidly Manufactured Ventilator Systems (RMVSs), to treat COVID-19 patients. To help meet this challenge, the UK government announced on 3 April 2020 that it will indemnify designers and manufacturers of RMVSs for claims relating to infringement of third-party intellectual property (IP) rights and for product liability claims resulting from defective equipment.

Formal notification of the two indemnities was given by the Minister for the Cabinet Office, Michael Gove, to the Public Accounts Committee on 3 April 2020.[1] In the notice, Minister Grove noted that he could not give the normal fourteen sitting days’ notice because “commercial negotiations have only just concluded and contract signature did not allow further delay”. Details of the terms of the referenced agreement have not, however, been provided, as they were said to be commercially sensitive and would continue to be until negotiations had been finalised. It is therefore not yet clear who are the parties to the agreement, whether any cap will apply to the indemnities, whether the government will offer the same terms across the board, or whether it will negotiate them in individual supply agreements.

Continue Reading UK Government Offers IP Indemnity to Designers and Manufacturers of Ventilators for COVID-19 Patients

On 7 April 2020, the European Medicines Agency (EMA) issued a Notice to sponsors on validation and qualification of computerised systems used in clinical trials (Notice). This Notice was developed by the EMA’s GCP Inspectors Working Group (IWG) and the Committee for Medicinal Products for Human Use (CHMP) to highlight for clinical trial sponsors the legal and regulatory requirements which apply to software tools used in the conduct of clinical trials.

In addition, the EMA updated the Answers to Questions 8 and 9 of the Agency’s Q&A on Good Clinical Practice (GCP) (GCP Q&A) in line with the Notice.

Continue Reading EMA’s Notice on validation and qualification of software tools used in clinical trials

The EMA and the competent authorities of the EU Member States have issued guidance to manage the conduct of clinical trials and the supply of medicinal products during the COVID-19 pandemic. This Guidance is particularly important for all sponsors conducting studies in the EU and for pharmaceutical companies supplying medicines in the EU. We discuss the key elements and practical implications for the concerned pharmaceutical companies in our recent advisory.

With only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020, the Commission has taken various steps towards its implementation. As we have discussed, while there are lots of good intentions, there is still much to be done –  although it now seems that a delay to the May date is on the horizon.

Last week, the MDCG published a number of guidance documents providing much needed clarity on some of the “priority” areas. These are set out below, with particular comments on the guidance relevant to the transitional provisions under the MDR.

Continue Reading Two months to go: Latest on implementation of EU MDR (Part 2)

As set out in our previous post, it is two months until the (current) date of application of the Medical Devices Regulation (MDR) on 26 May 2020. In this series of posts, we wanted to update you on the state of implementation given the fast-approaching deadline. However, as we were speculating that the current timeframe was looking increasingly untenable, the Commission announced yesterday (25 March) that it was working on a proposal to postpone the date of application by a year. This is intended to allow national authorities and industry to focus on responding to the coronavirus crisis.

The statement notes that “The Commission is working to submit this proposal in early April for the Parliament and the Council to adopt it quickly as the date of application is the end of May.” It has also been reported that the Parliament is receptive to such a proposal, and is aware of the tight timeline.

While we don’t yet know what the terms of the proposal will be, or how it will operate with all the various transitional provisions within the MDR, it will be welcome news to the industry, which is already under pressure due to the new provisions under the MDR, and now the coronavirus pandemic. We will keep you updated as more information is published.

 

 

There are now only two months to go before the date of application of the Medical Devices Regulation (MDR) on 26 May 2020. We have previously published updates on various implementation activities, and the concerns of industry and stakeholders that the deadline has been fast approaching but that there remains a huge amount to be finalised. The difficulties surrounding Brexit, and now the coronavirus pandemic, only add to these concerns. With the short amount of time remaining, we set out in this series of posts a summary of recent key developments.

As expected, the recent activity is focused on the MDR, and does not, on the whole, address the In Vitro Diagnostics Regulation (IVDR), which is due to be applicable in 2022. While this is a pragmatic approach from the institutions given current timing, it remains the case that IVD manufacturers have little clarity on how the IVDR will operate, and it seems, are unlikely to obtain any in the near future.

Continue Reading Two months to go: Latest on the implementation of EU MDR (Part 1)

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

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.

Case against PIP’s insurer

The Opinion of Advocate-General Bobek in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IARD SA concerns a German claimant (RB) who pursued a case for compensation in respect of defective breast implants in Germany against Allianz,[2] the insurers of the now-defunct PIP in France. Medical device manufacturers were required under French law to have insurance cover for harm suffered by third parties arising from their activities. PIP had a policy of cover with Allianz, but the cover was limited to damage caused in France. Allianz relied on that territorial limitation. RB maintained that the territorial limitation of insurance cover to French territory was not lawful and constituted an infringement of free movement of goods.

The German court referred the case to the Court of Justice of the European Union (CJEU), asking whether the territorial limitation in the Allianz insurance policy constituted a violation of Article 18 TFEU, which prohibits discrimination on the grounds of nationality.

Within the scope of EU law

Allianz and the French government argued that the case fell outside the scope of EU law on the basis that the issues involved a German patient who underwent surgery in Germany and were therefore purely internal to Germany. The Commission seemingly adopted a similar view.

Advocate-General Bobek disagrees, concluding that it is not possible to say that the situation in the present case falls outside the scope of EU law as it involved the cross-border movement of goods (PIP implants) and provision of services (insurance) in the context of the partial harmonisation of medical devices and liability for defective products under EU law.

Continue Reading Medical Devices and Compulsory Insurance in the EU