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Focus on Regulation

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

On Tuesday, FDA announced the availability of a draft guidance, “Principles of Premarket Pathways for Combination Products,” with high-level information on ways to bring combination products to market.  Although the draft guidance doesn’t break new ground, it provides some useful clarity; for example, it includes detailed illustrations of five circumstances when those pathways apply.

Citing existing FDA manuals and guidance documents, the 22-page draft guidance addresses the:

  • definition of combination products under 21 CFR 3.2(e)
  • jurisdictional assignment of combination products to agency Centers
  • approval pathways available for device-led, drug-led, and biologic-led combination products, as well as considerations for making such pathway determinations
  • safety and effectiveness data and information sponsors must offer, depending upon the pathway

Other key issues: Continue Reading

New Brexit Q&A provides several examples in relation to the “placing on the EU market”of products including medical devices

On 1 February 2019, the European Commission published a new Q&A document to give further guidance on the Notice to stakeholders-withdrawal of the United Kingdom and EU rules in the field of industrial products (“the Notice”). This Notice applies, among others, to medical devices, active implantable medical devices and in vitro medical devices. The Q&A document provides concrete guidance on the concept of products placed on the Union market before Brexit and the transfer of Notified Bodies certificates.

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A New European Deal?

German Minister of Economics suggests revising EU and German merger control regulations to enable the creation of European champions – and keeps FDI options on the table to prevent acquisitions by non-European players

The German Federal Minister of Economics, Peter Altmaier, published a paper on 5 February 2019 entitled “National Industry Policy 2030” which sets out the “strategical guidelines for a German and European industry policy” (to be accessed here in German). The paper aims to address the economic changes brought about by globalisation, protectionism and disruptive new technologies. It proposes a two-pronged solution to these developments: loosening EU and German merger control rules to benefit European-only mergers while maintaining a tight German Foreign Investment Control regime (the latter having only recently been amended, see here for more information).

In this paper, the Minister outlines the key technical competencies he believes Germany and Europe should better harness in order to keep up with international developments. The Minister expresses concern that, in the absence of such efforts, Germany and Europe will no longer be technological leaders and could forgo the chance to become such leaders in the future. The paper focuses in particular on the following areas of growth: digitalisation, platform economy, AI, autonomous driving, medical diagnostics and automation of production (i.e. the so-called Industry 4.0). Continue Reading

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence Evaluations) provides the greatest benefit to patients and providers, and (perhaps in particular) generic drug developers.  The Commissioner’s announcement addresses several important issues, including patent listing standards and therapeutic equivalence ratings.

Dr. Gottlieb said that in the coming year, FDA will issue draft guidance describing how the FDA evaluates therapeutic equivalence (TE) and assigns TE codes, which are published in the Orange Book. Continue Reading

The Modern Slavery Act: stricter reporting requirements on the horizon

MPs commissioned by the UK Government to review the Modern Slavery Act have published an interim report on the Transparency in Supply Chains Provision in s.54.  This blog looks at some of the key recommendations and what they would mean for UK business.

The MPs were asked: “how to ensure compliance and drive up the quality of slavery and human trafficking statements produced by eligible companies.”  The Report acknowledges that when the MSA was introduced in 2015, it was ground-breaking.  However, it also notes general agreement between businesses and civil society that a lack of enforcement and penalties, as well as confusion surrounding reporting obligations have led to poor quality statements and low levels of compliance.  On this basis, it concludes that the current provision is not sufficient and that it is time for the Government to take tougher action to ensure companies take seriously their responsibilities to eradicate modern slavery from their supply chains.


Drawing on expert reports and a comparative study of international legislation (notably the Australian Modern Slavery Act which came into force earlier this year (see our previous blog post)), Continue Reading

New Belgian legislation on the distribution of medical devices

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices. The Royal Decree forms part of a package of measures for the implementation of Regulation (EU) 2017/745 on medical devices, also known as the Medical Device Regulation. The distribution of certain medical devices will now be possible via new intermediaries. It will no longer be the prerogative of certain specific healthcare professionals. Supermarkets, for example, will now be able to distribute medical devices. This Royal Decree will be applicable on 7 February 2019.

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European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem


The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities responsible for the procurement of (in vitro) medical devices with guidance concerning Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR).

This factsheet is one of several guidance documents published by the European Commission to clarify points and answer questions regarding the implications of the MDR and the In Vitro Device Regulation.

Although the main aim of the factsheet is to help economic operators prepare for public tenders involving (in vitro) medical devices, it can also be useful to companies wishing to participate in a medical device tender.

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The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare allergic diseases


On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are currently applicable. They provide guidance for the clinical development and quality control of medicinal products containing allergens. All of these guidelines start from the premise that the population of the clinical trial is large enough to gather adequate data.

The goal of the concept paper is to create a scientific guideline for the development and manufacturing of medicinal products for the treatment of rare allergic diseases. The consequence of the smaller population is that there is not enough adequate data to develop treatment for these diseases. Continue Reading

Hogan Lovells publishes Demystifying the U.S. CLOUD Act

Hogan Lovells has published Demystifying the U.S. CLOUD Act, a detailed analysis of the impact of the Clarifying Lawful Overseas Use of Data Act (CLOUD Act) on non-U.S. businesses and individuals who use cloud storage solutions.

Demystifying the U.S. CLOUD Act was written by Hogan Lovells partners Winston Maxwell and Mark Brennan, and senior associate Arpan Sura. Continue Reading

Jabir and others v. KiK Textilien und Non-Food GmbH – Dortmund court dismisses lawsuit

Yesterday, the Regional Court (Landgericht) of Dortmund dismissed the claims in Jabir and others v. KiK Textilien und Non-Food GmbH (Case No. 7 O 95/15) based on the statute of limitations.  The case concerned claims for personal injury and death brought by four Pakistani nationals against German retailer KiK Textilien and Non-Food GmbH (“KiK”) in relation to a fire in the Karachi factory of KiK’s supplier Ali Enterprises.  The case is noteworthy, as it was the first time that damages claims based on the liability of a transnational company for human rights violations abroad have been pursued before German courts (see our previous blog post here).

The Dortmund court found that Continue Reading