The conduct of clinical trials still relies heavily on the use of paper documents. Of course, electronic case report forms (eCRF) have been commonly used for many years – the medical information on a patient that is transferred from the clinical trial sites (hospitals/HCPs) to the sponsor (i.e. pharma or device company) is transmitted in electronic form. The trial site’s medical information, the socalled source data is usually stored in paper and/or in electronic hospital information systems. But apart from this, the recruitment of patients, their consent process and the capture of source data is done manually – often in paper format. However, the future is likely to look different. More and more aspects of the administration and conduct of a clinical trial will be done electronically and automatically. Continue Reading
In the EU, digital health technologies such as medical apps or wearable sensors can fall within the scope of the medical devices directives. These directives provide the basic definition of a medical device and lay down the technical and procedural obligations that must be followed by the manufacturer of a medical device prior to affixing a CE mark to the product. The EU definition of a medical device is quite similar to that in the U.S. and is as follows: Continue Reading
Many digital health products are regulated by the U.S. Food and Drug Administration (FDA) as medical devices or, when used in conjunction with a specific drug or biological product, as combination products requiring clearance or approval from the agency prior to marketing.
Regulation of standalone devices
The FDA regulates medical devices products, including software applications, that are intended for use in the treatment or diagnosis of individual patients. The agency interprets this definition quite broadly, including, for example, regulation of tools used for capturing medically-oriented data (e.g., ECG data) or tools used for screening healthy persons for disease. For product comprised only of software, changes enacted under the 21st Century Cures Act recently exempted certain functions from the definition of a medical device, such as simple transfer and display of existing medical device data and certain clinical decision support functions. For products not exempted by these recent changes, the key to determining whether the product falls into the definition of a medical device is the intended use, which is determined by the intent of the manufacturer as evidenced by the design of the product and the labeling. Continue Reading
An updated Model Clinical Trial Agreement (mCTA) has been published for industry-sponsored clinical trials involving patients in National Health Service (NHS) or Health and Social Care (HSC) hospitals in the UK.
The mCTA is a standard form contract which is intended to be used by clinical trial sponsors and NHS/HSC organisations without modification. Previously, under the 2011 version, separate agreements were required for each of the four nations – England, Scotland, Wales and Northern Ireland. The new template enables a single agreement to be used throughout the UK, streamlining the process for companies wishing to conduct clinical trials at multiple sites.
The mCTA for industry-sponsored trials involving Clinical Research Organisations (CRO-mCTA) has also been updated, together with the accompanying guidance for both the mCTA and CRO-mCTA. Both agreements have been amended to reflect changes in legislation and guidance, including the General Data Protection Regulation (EU) 2016/679 and the 2015 ABPI Clinical Trial Compensation Guidelines.
The mCTAs were developed by the UK Government working jointly with the Association of the British Pharmaceutical Industry (ABPI), with input from stakeholders including the Health Research Authority and Medical Research Council. There are also separate model agreements for non-commercial research/investigator initiated trials, collaborative research and trials in primary care settings.
The revised mCTA and CRO-mCTA are available here.
On Feb 27th, China Food and Drug Administration (CFDA) published their inspection reports for eight international medical device manufacturers located in U.S., Europe, Japan, and Australia under its Medical Device Good Manufacturing Practice.
CFDA began to publish these oversea inspection reports on its website starting from November, 2017. On December 15, 2017, CFDA suspended the import authorization of a medical device due to severe deficiencies observed during an on-site inspection. Continue Reading
After the tragic February 14 shooting at Marjory Stoneman Douglas High School in Parkland, Florida, students across the country have taken to the streets. Students have met with lawmakers, engaged in protests, and staged school walkouts. Student activists have organized a March for Our Lives scheduled for March 24 and have planned similar demonstrations, including National School Walkouts on March 14 and April 20. The school walkout dates mark one month since Parkland and 19 years since Columbine, respectively. As school leaders across the country consider whether, under what circumstances, and how to address student activism, it is important that they remember the First Amendment. Below, we briefly outline five key points to consider.
- Students have First Amendment rights at school. The law is clear that students do not shed their First Amendment rights at the “schoolhouse gate.” Although students do not have the same rights at school as they have on a public street corner, school districts do not have free reign to punish student speech.
- Students do not have a First Amendment right to cause a substantial disruption at school. In the famous Tinker case, the U.S. Supreme Court ruled that school districts may regulate speech that results in actual or reasonable forecasts of “substantial disruption of or material interference with school activities” or the rights of others. In that case, the Court ruled that the district violated the Constitution by punishing students who wore black armbands at school to protest the Vietnam War. Although the protest generated some squabbling among students, the Court described it as a “few students” who made “hostile remarks to the children wearing armbands, but there were no threats or acts of violence on school premises” or disruptions of class. Caselaw defines what counts as a “material disruption,” and the answer may vary by jurisdiction.
- Students do not have a First Amendment right to cut school or class, but schools generally may not punish students for purely off-campus speech. Some courts have held that students do not have a First Amendment right to engage in walk-out protests in violation of school truancy rules. They have reasoned that neutral applications of truancy rules are valid content-neutral restrictions on speech and/or that truancy creates a substantial disruption under Tinker. For example, a walk-out would seem to disrupt all missed classes and a school may need to close or divert resources to protect student safety.At the same time, school districts generally may not punish students for off-campus speech. So, if students are at a Saturday protest unaffiliated with the school district, the district ordinarily cannot punish students for their conduct at the protest. It is also important to consider social media, which often blurs the lines between off- and on-campus speech. A number of courts have wrestled with whether and under what circumstances districts may regulate online speech. However, multiple courts have held under the Tinker framework that districts can in certain circumstances punish students for social media posts threatening violence at school.
Given the above principles, some school leaders are seeking to engage with students to remind them about any applicable place, time, and manner restrictions on activism and/or to engage with them about safe, productive ways to make their voices heard. School leaders should always be attentive to student safety and security.
- School districts may not compel students to engage in purely political protests. The U.S. Supreme Court has long held that school districts may not force students to stand and salute the flag during the Pledge of Allegiance. To force students to engage in such pure political speech is a violation of the First Amendment’s compelled speech doctrine—the First Amendment protects not only the right to speak, but also the right to remain silent. The Court has explained that the government may not “force an individual . . . to be an instrument for fostering public adherence to an ideological point of view he finds unacceptable.” Of course, school districts routinely force students to speak in connection with the academic enterprise. A student may not assert a First Amendment right to refuse to give a book report, for example. So, while a district might require students to prepare a research paper on guns in America, it would seem inadvisable for a district to require students to engage in a political protest advocating one side of an issue. School districts—which have their own free speech rights—are free to stake out their own position and to invite community stakeholders to help spread that message.
- School districts must avoid unconstitutional viewpoint discrimination. Some districts may be considering whether to take disciplinary action against students who choose to protest school violence by participating in a walkout or otherwise. Districts should understand, however, that if they choose to grant leniency to students who support certain solutions to school violence, they may not engage in viewpoint discrimination by throwing the book at students who support other solutions to school violence merely because school leaders do not favor that option. Selective enforcement could amount to unconstitutional viewpoint discrimination where the government singles out one side of an issue for censure.
Although the First Amendment is a crucial consideration for school leaders, it is not the only one. Groups such as AASA and NSBA have provided guidance about how to address school-related violence and to respond to student activism. Also, because First Amendment law is often nuanced and fact-dependent, school leaders should consult with their legal counsel as they formulate and implement policy in this area.
The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations that must be met by distributors in relation to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Although the MDR and the IVDR are not applicable before respectively 26 May 2020 and 26 May 2022, it is important that all economic operators, including distributors, start preparing for their new related obligations as soon as possible. Continue Reading
The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new question concerning the preparation of the dossier.
The EMA’s guidance document helps applicants for marketing authorisations in the European Union (“EU”) to prepare correct and timely pre-authorisation submissions within the centralised procedure.
The guide addresses a number of questions which applicants through the centralised procedure may have concerning pre-authorisation applications.
The guidance document is structured into Question & Answers. It is revised regularly to keep pace with new developments and to reflect the implementation of the new EU legislation. The document should be read in conjunction with The rules governing medicinal products in the European Union, Volume 2A, Notice to Applicants.
The new question
Updated topics in the guidance document are marked as “NEW” or “Rev.” with the relevant date of publication.
The recent 6 February 2018 version includes the following new question in Section 3 on the preparation of the dossier:
“What is a multipack presentation and which information should include in the product information for a multipack presentation?”
The answer clarifies that the term “multipack” can be included in the dossier solely when it concerns a presentation composed of several single authorised packs of the same strength. The guidance document provides related detailed advice concerning preparation of the multipack outer carton and inner boxes.
On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and IVDs should take to avoid negative after-effects following Brexit. Should the position expressed in the notice prove accurate, medical device and IVD stakeholders will face stringent consequences following the UK’s withdrawal from the EU.
UK Manufacturers and Importers and EU-based Distributors
EU product legislation as well as the new Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation provide that importers, manufacturers, distributors of products and authorised representatives fall within the definition of an “economic operator”.
After Brexit, the UK would become a third country. The notice provides that any UK manufacturer or importer will no longer be perceived as an economic operator established within the EU after Brexit. Moreover, EU distributors of UK medical devices or IVDs based in the remaining Member States will become importers of third-country products thereafter. Consequently, they will have to comply with specific obligations, which are different from those of a distributor.
According to the Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive, as well as the new Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation, manufacturers of medical devices imported into the EU from a third country are required to appoint an authorised representative established in the EU (“European Authorised Representative”).
It is currently estimated that approximately 50% of the European Authorised Representatives in the medical devices industry are based in the UK. After 29 March 2019 (the date set for Brexit), authorised representatives established in the UK will not be considered as European Authorised Representatives and will, therefore, be unable to fulfil this role on behalf of non-EU legal manufacturers.
The Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation also introduce a new requirement for manufacturers and European Authorised Representatives to have at their disposal at least one qualified person responsible for regulatory compliance who should be based in the EU. The limited recommendation for manufacturers provided by the European Commission in this respect in the notice is to “take the necessary steps to ensure that, as from the withdrawal date, their designated authorised representatives or responsible persons are established in the EU-27“.
Non-recognition of UK-Notified Bodies
According to the document, following the anticipated withdrawal of the UK from the EU, UK Notified Bodies will not be considered EU Notified Bodies. They will be erased from the European Commission’s Nando database, which includes the details of all Notified Bodies in the EU. As a result, UK Notified Bodies will no longer be permitted to provide conformity assessment services in accordance with EU product legislative framework and issue related CE Certificates of Conformity.
Medical devices which are CE marked by UK legal manufacturers and are placed on the EU market will, after Brexit, need to have related CE Certificates of Conformity issued by a Notified Body licensed by the competent authorities of one of the 27 EU Member States. Legal manufacturers of medical devices that currently hold a CE Certificate of Conformity issued by a UK notified body yet intending to continue marketing their devices in the EU will be required to choose one of two solutions. According to the first solution, they will need to seek a CE Certificate of Conformity issued by a notified body licensed in one of the remaining EU Member States. The second option would be to transfer the technical file and related to the medical device and the existing CE Certificate of Conformity issued by a UK notified body to a notified body licensed in one of the remaining EU Member States on the basis of a contractual arrangement between the manufacturer, the UK Notified Body and the Notified Body of one of the remaining Member States.
 See for example: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices; Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys; Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC; Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC; Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC.
In the last four months, the Court of Appeal has handed down judgment in two important cases relating to parent company liability and jurisdiction over extra-territorial human rights impacts. In October, we wrote that the first of these cases (Lungowe and others v. Vedanta and KCM  EWCA (Civ) 1528) created a “Catch 22” for English domiciled multinationals – by fulfilling the responsibility to respect and implementing group human rights policies, they risked increasing the likelihood of a duty of care arising which could be used to establish jurisdiction. The judgment handed down last week in Okpabi and others v Royal Dutch Shell Plc and another  EWCA Civ 191 goes some way to resolving this Catch 22 and provides some useful guidance on how responsibly to manage human rights risk without inadvertently increasing the risk of litigation.
Factual and legal background
In January 2017, the High Court decided in favour of Shell and its Nigerian subsidiary, upholding challenges to the jurisdiction of the English courts over claims by victims of oil leaks from pipelines in the Niger Delta. Fraser J found that the claimants had failed to present a properly arguable case that Shell directly owed them a duty of care. Absent proceedings against a UK-domiciled anchor defendant, the court found that there was no connection between the claims against the Nigerian subsidiary and the English courts. The claimants appealed on the basis that Fraser J had erred in his analysis and asked the court to reconsider whether Shell owed a duty of care to those affected by the oil leaks.
Outcome of appeal
The appeal was dismissed. A majority of the Court (Sales J dissenting) held that Fraser J had been correct to conclude that the claimants could not demonstrate a properly arguable case that Shell owed a direct duty of care to the claimants (albeit that they reached this conclusion on different grounds to the trial judge). In reaching their judgments, the Court cited the formulation for establishing parent company liability adopted by the same Court in Vedanta:
“(1) The starting point is the three-part test of foreseeability, proximity and reasonableness. (2) A duty may be owed by a parent company to the employee of a subsidiary, or a party directly affected by the operations of that subsidiary, in certain circumstances. (3) Those circumstances may arise where the parent company (a) has taken direct responsibility for devising a material health and safety policy the adequacy of which is the subject of the claim, or (b) controls the operations which give rise to the claim. (4) Chandler v. Cape Plc and Thompson v. The Renwick Group Plc describe some of the circumstances in which the three-part test may, or may not, be satisfied so as to impose on a parent company responsibility for the health and safety of a subsidiary’s employee. (5) The first of the four indicia in Chandler v. Cape Plc , requires not simply that the businesses of the parent and the subsidiary are in the relevant respect the same, but that the parent is well placed, because of its knowledge and expertise to protect the employees of the subsidiary. If both parent and subsidiary have similar knowledge and expertise and they jointly take decisions about mine safety, which the subsidiary implements, both companies may (depending on the circumstances) owe a duty of care to those affected by those decisions. (6) Such a duty may be owed in analogous situations, not only to employees of the subsidiary but to those affected by the operations of the subsidiary. (7) The evidence sufficient to establish the duty may not be available at the early stages of the case. Much will depend on whether, in the words of Wright J (in Connelly v. RTZ Corporation Plc  C.C.C 533), the pleading represents the actuality.”
Neither party contested this formulation and it was applied without question in the judgment of the majority and in Sales LJ’s dissent. As such, it now seems to be settled and, at least from the perspective of creating legal certainty, this is a welcome development. The precise contours and practical significance of each of these propositions will likely be the subject of further litigation and debate.
Does adopting a group human rights policy increase the likelihood of a parent owing a direct duty of care?
The third proposition (that a parent might owe a duty to a third party directly affected by the operations of a subsidiary in circumstances where the “parent company has taken direct responsibility for devising a material health and safety policy the adequacy of which is the subject of the claim or controls the operations which give rise to the claim”) had prompted concerns that English multinationals would be dissuaded from fulfilling their responsibility under the UN Guiding Principles on Business and Human Rights, including to devise, publish and implement group human rights policies.
Notably, the Court in Shell did not restrict the application of this proposition to “health and safety” policies, instead referring generally to “policies the adequacy of which is the subject of the claim” [88, 132] and considering evidence from Shell’s sustainability report (amongst other, non-health and safety specific, documents). On this basis, there would be nothing to prevent an English court from considering a company’s human rights policy in determining whether a duty of care arises to prevent human rights violations which also give rise to a cause of action under the applicable law.
However, all three judges agreed that the mere existence of such policies does not create a duty of care. Simon LJ held that:
“The issuing of mandatory policies plainly cannot mean that a parent has taken control of the operations of a subsidiary (and, necessarily, every subsidiary) such as to give rise to a duty of care in favour of any person or class of persons affected by the policies.” 
The Court distinguished between a parent company which takes steps to ensure that there are proper controls in place by establishing an overall system of mandatory policies, processes and uniform practices on the one hand and a parent company which actually seeks to exercise control on the other [125, 140]. Only in the case of the latter might a duty of care arise.
Agreeing with Simon LJ, the Chancellor held that:
“The detailed policies and practices do not seem to have been tailored specifically for SPDC. Rather, they all apply across the board to all RDS subsidiaries and joint ventures, without distinction. It has already been said that it would be surprising if an international parent were to owe duties to those affected by the operations of all its subsidiaries and that there needs to be something more specific for the necessary proximity to exist.”
By way of example, he suggests that proximity between a parent and a third party affected by the operations of a subsidiary might exist where the third party is injured by a food product which is manufactured by a subsidiary according to a prescriptive recipe provided by its parent. This raises two further, important points: first, any attempt to suggest that the existence of a group human rights policy which requires subsidiaries to respect human rights creates the necessary proximity to found a duty of care would strain this analogy; second, a policy may be more likely to evidence a duty of care where it is devised for a particular subsidiary as opposed to the corporate group as a whole [121, 195].
So, the short answer to the question posed above is “no”. UK multinationals should not be deterred by these cases from adopting global human rights policies and frameworks. However, in practice, they should ensure that:
- the policy is applicable to all group companies rather than specific subsidiaries; and that
- the responsibility for implementing these policies (including by carrying out due diligence) is at subsidiary level. As we have written previously, not only will this reduce the risk of a duty of care arising, it will likely be more effective in reducing the risk of an adverse human rights impact in the first place as operating companies will often understand the human rights risk in a particular context better than someone at HQ and be better placed to identify it and effectively mitigate against it. This may require that resources are allocated to ensure that in country personnel are properly trained in human rights due diligence to ensure that they can effectively discharge this function.