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Focus on Regulation

We are the Champions – France and Germany unite to revive industrial policy at European level

Following the European Commission’s prohibition of the Alstom-Siemens transaction, the French and German governments published a manifesto calling for a reform of current EU merger rules, in order to shape a “European industrial policy fit for the 21st Century“. This manifesto appears to be directly addressed to the next European Commission, which will be renewed following the European elections this year.

The Franco-German manifesto (see here) directly stems from the Alstom/Siemens prohibition decision which was criticized by the French and German governments, as they viewed the merger as a unique opportunity to create a “European Champion” able to compete with increasingly powerful Chinese competitors. Ignoring such political considerations, the European Commission assessed that the remedies offered by Alstom and Siemens were insufficient in order to address the competition concerns raised by the transaction, notably in consideration of the very high market shares held by the parties in the  high-speed trains and railway signaling systems markets. Continue Reading

Poland: Post-registration changes required in case of no-deal Brexit

On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit.

In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration changes in their medicinal product documentation. These changes concern: Continue Reading

FDA’s Bendeka decision reverses approvals of Treanda generics

Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle Pharmaceuticals, Inc. v. Azar, No. 16-790, ECF No. 64 (D.D.C.) (Jun. 8, 2018).  At issue following the Eagle decision was whether the exclusivity would block approval of generics to Treanda, a bendamustine product previously approved for the same orphan indications.  FDA has decided that generics to Treanda are subject to Bendeka’s orphan exclusivity, and therefore (1) pending ANDAs will not receive final approval until December 7, 2022 (when Bendeka’s orphan exclusivity expires), and (2) ANDAs that were approved after December 7, 2015 (the date of Bendeka’s approval) will be converted to tentative approval until expiry of the exclusivity. Continue Reading

Pharmaceutical Sector remains under Scrutiny of EU Competition Enforcers

On 28 January 2019, the European Commission published its Report to the Council and Parliament regarding “Competition enforcement in the pharmaceutical sector (2009-2017)” (“Report“). The Report summarizes the impressive enforcement activity of EU competition law enforcers in the pharmaceutical sector in the last decade while emphasizing at the same time the scope for continued enforcement action.

The political agenda pursued by the Commission is clearly demonstrated by a quote of EU Commissioner for Competition, Margrethe Vestager:

“Giving European patients and healthcare systems access to affordable and innovative medicines is one of Europe’s main challenges and objectives. The report […] provides key insights into the valuable work that competition authorities across Europe are doing to ensure that pharmaceutical markets help achieve this goal. It is important that we continue giving a high priority to our work in this area.” Continue Reading

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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