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Focus on Regulation

With the Statutory Deadline Approaching, FDA Issues a Proposed Sunscreens Rule

On February 26, FDA published the proposed rule, “Sunscreen Drug Products for Over-the-Counter Human Use,” which describes the conditions under which Over-the-Counter (OTC) sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Primarily, the proposed rule seeks additional information on sunscreen ingredients so that FDA can evaluate their GRASE status in light of changed conditions, including substantially increased sunscreen usage and exposure, and evolving information about the potential risks associated with these products.  The proposal is for a final monograph on sunscreens, which would substantially amend the 1999 final rule on sunscreens that was stayed before its effective date. Continue Reading

Poland: New Medical Research Agency

On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM).

The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will primarily consist in co-financing scientific research and development work as well as interdisciplinary projects, with particular emphasis on clinical, observational and epidemiological research. Moreover, the Agency will be able to initiate and carry out its own scientific research and development work and, additionally, to expand international cooperation.

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Budha Ismail Jam, et al, Petitioners v. International Finance Corporation

Introduction

On 27 February 2019, the Supreme Court of the United States (SCOTUS) held that International Organisations do not have absolute immunity under the International Organizations Immunities Act of 1945 (IOIA). This blog discusses the opinion of the Supreme Court.

International Organisations

International Organisations have their own legal personality and status under international law and their rights and duties are determined by treaties. The World Bank Group’s private lending arm – the respondent in this matter – the International Finance Corporation (IFC) is one such International Organisation.

IOIA was enacted as a consequence of many International Organisations being headquartered in the U.S. It gives International Organisations a set of privileges and immunities. The purpose of International Organisation immunity is to allow such organisations to pursue the collective goals of member countries without undue interference from the courts of a member country. The question before the Supreme Court was whether the immunity enjoyed by the IFC in terms of IOIA is absolute.

Budha Ismail Jam, et al, Petitioners v International Finance Corp (JAM v IFC)

In 2008, the IFC lent $450 million to Coastal Gujarat, a power company based in India. The loan was to finance the construction of a coal-fired power plant. In 2015, a group of farmers and fishermen (the Petitioners) who lived near the power plant sued the IFC in a United States District Court. They claimed that pollution from the plant had destroyed or contaminated much of the surrounding air, land, and water. Relying on an IFC audit report (which concluded that not only did Coastal Gujarat not comply with the environmental and social action plan in constructing and operating the plant, but also that the IFC had failed to inadequately supervise the project) the Petitioners instituted various actions against the IFC. These included claims of negligence, nuisance, and breach of contract. The IFC argued that because of certain provisions of the IOIA it was immune from being the subject of a legal action and argued that U.S Courts had no jurisdiction. The District Court agreed with the IFC and so the matter proceeded on appeal.

The question before the Supreme Court was whether IOIA grants International Organisations the absolute immunity that foreign governments enjoyed when IOIA was enacted, or whether International Organisations enjoy limited immunity that foreign governments enjoy today. The Supreme Court favoured the later interpretation. The provision in question read as follows- “[international organisations] shall enjoy the same immunity from suit and every form of judicial process as is enjoyed by foreign governments.”

In reaching its conclusion, the Supreme Court had regard to the fact that IOIA defines immunities by reference to comparable privileges and immunities enjoyed by foreign governments. Therefore, using the “reference” canon method of interpretation – that when a statute refers to a general subject, the statute adopts the law on that subject as it exists whenever a question under the statute arises – the Supreme Court held that the reference to the immunity enjoyed by foreign governments in IOIA is a general rather than specific reference. Thus, the IOIA should be understood to link the law of International Organisation immunity to the law of Foreign Sovereign Immunity, as defined by the Foreign Sovereign Immunities Act (FSIA).

The IFC also argued that if the Supreme Court were to interpret IOIA’s immunity provision to grant anything less than absolute immunity that would lead to a plethora of claims against the IFC. In a quick overview of the meaning of ‘commercial activity’ in the FSIA, the Supreme Court considered that it is not clear that the lending activity of all International Organisations qualifies as commercial activity within the meaning of the FSIA. The Supreme Court held further that there is no good reason to think that restrictive immunity would expose International Organisations to excessive liability. Notably, the Supreme Court was quick to thwart any interpretation which could lead to claims based on tortious activity. “Thus, if the ‘gravamen’ of a lawsuit is tortious activity abroad, the suit is not ‘based upon’ commercial activity within the meaning of the FSIA’s commercial activity exception.”

The dissenting opinion was authored by Justice Breyer. He adopted a purpose based method of interpretation and held that having regard to IOIA’s history, context, purposes and consequences Congress intended for absolute immunity.

Conclusion

The Supreme Court’s opinion was welcomed by human rights groups as being a landmark ruling which “is a major step towards holding [the] World bank accountable for the negative impacts their investments are causing“.

However, this is only one of many ‘hurdles’ for the Petitioners and going forward they still need to prove not only that the IFC engaged in a commercial activity but also that a nexus between the commercial activity and the alleged harm exists. These claims will take years to finalise. Nevertheless, it is yet more evidence of the expanding web of accountability for alleged human rights impacts.

Julianne Hughes-Jennett, Head of Hogan Lovells Business and Human Rights Group, together with Bryce Wray – March 2019

Poland: official position of the competent authority on consequences for medical devices in the event of a no-deal brexit

On 1 March 2019[1], the President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued yet another communique concerning consequences of Brexit, this time with respect to the medical devices.

It is announced that in the event of a “no-deal” Brexit, as from 30 March 2019, the United Kingdom will be considered a third country. In this case the following consequences will affect:

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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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