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Focus on Regulation

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

Right-to-try laws and the future of access to investigational treatments

The treatment of patients with unapproved therapies is often referred to as “compassionate use” or “expanded access”. Under right-to-try laws, state-level legislation has paved the way for a new law at the federal level to expand access to these investigational medicines.

Expanding access to unapproved treatments through right-to-try

State-level right-to-try laws have given patients and their families hope that they might gain access to breakthrough investigational treatments. But traditionally, the FDA and pharmaceutical industry have been cautious about providing access to these treatments, at least without robust clinical study data providing preliminary evidence that the unapproved drug is effective. Continue Reading

European Commission Publishes Guidance on Brexit and UK Food Exports

On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a ‘third country’ from the date of its withdrawal from the EU. This will impact a number of key areas of EU food regulation, including:

  • Food labelling: changes will need to be made to labels of food products originating from the UK. An EU-based importer must be named on the product, and mandatory references to the origin of products will need to be changed from “EU” to “UK” or “non-EU”.
  • Food composition, contaminant levels and food contact materials: UK-produced food sold in the EU will remain subject to EU rules including requirements for certain ingredients to be authorised by the Commission (e.g. additives and flavourings and novel foods), maximum permitted levels of contaminants and residues in foodstuffs, and rules on food contract materials. These apply to all foods placed on the EU market, irrespective of the place of production.
  • EU establishment requirements and submission of EU authorisations: some products such as genetically modified food must have a food business operator, authorisation holder or a representative that is established in the EU. Establishments in the UK will no longer comply with this requirement. The Food Standards Agency, the UK’s competent authority, will also no longer be able to accept applications for EU authorisations such as for the cultivation and placing on the market of genetically modified materials, and for use of new materials in food contact materials.
  • Food of animal origin: the import of food of animal origin from the UK into the EU will be prohibited, unless certain requirements are met. These include:
    • the UK must be listed by the Commission as an approved third country for the export of each category of food of animal origin. The Commission has not addressed whether the UK will automatically be approved post-Brexit or whether the UK will need to apply for authorisation as a third country;
    • the establishment from which the food is dispatched and obtained or prepared must further be approved for the export of the specific category of food of animal origin;
    • the imported food satisfies all EU food hygiene requirements; and
    • the product will be subject to mandatory border checks and must enter the EU through approved border inspection posts of a remaining Member State.
  • Organic products: UK-originating organic foods will be subject to the same regulation as organic foods entering the EU from other third countries. In particular, all consignments of organic products must be accompanied by a certificate of inspection on import to the EU. These certificates can be issued by an authorised EU organic control body or authority or a non-EU control body or authority recognised as having equivalent standards as the EU. Certificates issued by UK bodies will no longer be valid.

The full notice published by the Commission is available here.

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

FDA recently released a draft guidance clarifying the regulatory requirements for public warnings in the event of a recall under the agency’s recall guideline at 21 CFR Part 7. The agency is turning to public warnings to alert the public that a recalled product presents a serious health hazard, where other means of preventing use of a recalled product appear inadequate. Although the guidance provides manufacturers some flexibility in communicating product recalls to the public, FDA articulates stringent standards for public notice, particularly with respect to how promptly they must issue public warnings. Continue Reading

FCC Avoids Shutdown For Now, But Continued Threat Looms Over TMT Sector

The federal government is open.  But less than three weeks remain under the current reprieve and another shutdown seems possible.  Although the Federal Communications Commission tapped on-hand fees to support uninterrupted operations earlier this week, the FCC will start to run out of time – and money – if the stalemate over the budget continues and another shutdown occurs.

How would a protracted shutdown affect the technology, media and telecom industries and the billions of dollars of investment that depend on regulatory action by the FCC?  How soon before Samsung and Apple face launch delays for products that need FCC approval to enter the market?  When will GoPro, Nintendo, Tile, Roku and other consumer electronics makers start to see product delays?  Will wireless emergency alerts continue to be available?  And will a shutdown affect the nation’s bid in the global race for leadership in the deployment of advanced, fifth-generation wireless networks?  These are just some of the questions as the technology, media and telecom sectors confront the possibility of an extended period of time without a functioning regulator.

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Freedom of Information Code of Practice Consultation

The Government is consulting (link below) on various revisions to the Code of Practice for public authorities on their obligations under the Freedom of Information Act 2000 (the “Act“). The revisions, which are intended to reflect developments in good practice, include the following:

  • additional guidance on fundamental principles, such as how to define “information” and “held” under the Act;
  • a requirement for greater transparency about public authorities’ compliance with the Act,  which will compel public authorities to publish quarterly and annual compliance statistics;
  • a requirement for the publication of senior officials’ pay and benefits to increase the information about senior executive remuneration that is accessible to the public;
  • greater clarity on when and how vexatious and repeated requests for information can be refused; and
  • the merging of all Act guidance into a single Code of Practice.

All responses to the consultation should be submitted by no later than 5pm on 2 February 2017.

Please speak to a member of the Hogan Lovells Public Law and Policy team if you would like any more information, or if you would like to discuss submitting a response to the consultation.

Revised Draft Code of Practice: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/659606/FOI_Code_of_Practice_-_Draft.pdf
Consultation Paper: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/659607/FOI_Code_of_Practice_Consultation_Document.pdf

Connected Vehicles in Focus at 2018 CES

In addition to displaying a wide array of next-generation connected vehicle technologies, the 2018 Consumer Electronics Show (“CES”) hosted lively discussion of the new possibilities that will be created as vehicles become capable of seamlessly communicating with other vehicles, infrastructure, and pedestrians.  In one panel, Connected Vehicles in Connected Ecosystems, participants from across industries explored what the shift means for data collection, business models, and ecosystems.

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Canada steps up human rights oversight of companies operating abroad

Last week, Canada announced the creation of the Canadian Ombudsperson for Responsible Enterprise (CORE), an independent officer who will be tasked with investigating allegations of human rights abuses linked to Canadian corporations operating abroad.

The CORE’s predecessor, the Extractive Sector Corporate Social Responsibility Counsellor, required the permission of a company to investigate a complaint and came under fire from NGOs for being ineffective.  Indeed, none of the six complaints it received since the role’s inception in 2009 were investigated or otherwise resolved.  The CORE will have the power to initiate investigations, and, if warranted, recommend remedies and monitor their implementation.  The CORE may also assist the resolution of disputes or conflicts between impacted communities and Canadian companies.

Although the CORE will not have the power to impose sanctions or penalties, its investigations and any findings or recommendations, will be made public. In his announcement on 17 January, the Canadian Minister for International Trade, Francois-Philippe Champagne, added that the government would also consider withdrawing trade advocacy support (or funding or political risk insurance from Export and Development Canada) if the CORE recommends it.

This is an unprecedented step, and one that will be of particular interest to the world’s mining industry – 60% of which is based in Canada. The initiative has already been welcomed by several Canadian mining companies.  Although the creation of the CORE was supported by advocates for mining-affected people, and the CORE will initially focus on the mining, oil and gas and textile industries, its mandate is expected to expand (within a year) to all other sectors in which Canadian companies operate abroad.

The CORE will report to Parliament, but will be independent from the Canadian government – in fact, its recommendations may include policy and legislative recommendations to the government itself.  A multi-stakeholder advisory body, including representatives of civil society and industry, has also been set up to advise the CORE and the government on the effective development and implementation of laws, policies and practices to encourage socially responsible conduct by Canadian companies operating abroad.

We will have to wait to see how effective the CORE is.  It is certainly to be hoped that the broad-ranging support for the creation of the CORE translates into constructive cooperation between government, business and nongovernmental organisations to achieve greater respect for human rights.

European Commission released GMP Guidelines for Investigational Medicinal Products

On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. The document supplements the EU Delegated Regulation adopted in 2017 setting out GMP obligations for investigational medicinal products. The Delegated Regulation establishes a  pharmaceutical quality system for manufacturing operations.

The guidelines govern manufacture and import into the EU of investigational medicinal products for human use. The purpose of the GMP guidelines is to provide appropriate yet flexible tools to address specific issues related to good manufacturing practice requirements for investigational products. The document includes instructions concerning:

  • Pharmaceutical quality systems, in particular, product specification file which should include all of the essential reference documents to demonstrate compliance of investigational drug’s manufacturing with GMP and clinical trial authorisation requirements;
  • Personnel;
  • Premises and equipment;
  • Generation, control and retention of documentation, including specifications and instructions, ordering, manufacturing formulae and processing instructions, packaging and batch records;
  • Production, including packaging materials, manufacturing operations and modification of comparator products as well as blinding operations, packaging and labelling;
  • Quality control;
  • Release of batches;
  • Outsourced operations;
  • Procedures for complaints;
  • Recalls, returns and destruction of investigational drugs.

The guide also recognises a need for co-operation between manufacturers and sponsors of clinical trials under a technical agreement.

The guidelines will become applicable once the Clinical Trials Regulation enters into force, which is expected in 2019.

U.S. Department of Education Publishes List of Schools Under Civil Rights Investigation

This week, the U.S. Department of Education (“ED”) published on its website a list of “pending cases currently under investigation” by its Office for Civil Rights (“OCR”). Previously, OCR had released a list of higher education institutions under investigation for possible violations of law related to the handling of sexual violence and sexual harassment under Title IX. The new list is broader: it encompasses complaints bought under other civil rights laws enforced by ED, and it includes complaints against K-12 schools as well as higher education institutions.

The list is sorted by category of civil rights law enforced by ED (i.e., age discrimination, race and national origin discrimination, sex discrimination, disability discrimination, Boy Scouts of America Equal Access Act). The list is sortable by state, institution name, institution type, type of discrimination, and the date the investigation was opened. The list is also searchable.

OCR describes the list as a “snapshot of data” that reflects its enforcement efforts as of a particular point in time (i.e., the last Friday of each month). ED has said it will update the list on the first Wednesday of each month. According to OCR, inclusion on the list “means that a complaint was filed with OCR and the agency determined that a complaint should be opened for investigation.” An institution will remain on the list for as long as OCR “is still investigating” or “is otherwise working to resolve” the complaint.


FDA’s Proposed New Pathway for Devices Referencing Drugs (DRDs)

The Food and Drug Administration (FDA) may be closing in on solving one of its perennial regulatory problems, namely, the absence of a workable regulatory pathway for devices that seek to use older, mainly generic drugs in innovative ways. Under the current system, where a device sponsor proposes to label its device for use with a drug in a manner that may go beyond the existing drug labeling, FDA typically requires the submission of a new drug application (NDA). An NDA or supplemental NDA is often called for to modify the drug labeling to reflect the proposed use by the device. This puts the device sponsor in a regulatory box: (1) collaborate with the drug sponsor to seek the labeling change, (2) become a drug sponsor itself and file the NDA directly; (3) seek more general device labeling; or (4) abandon the program (at least in the U.S.). Where the drug is already available in generic form, device sponsors have found it nearly impossible to find a willing drug sponsor interested in developing new labeling for the drug. Further, device companies often reject the idea of becoming a drug sponsor where their device can be used with existing and already approved drug. All too often, we have seen device innovators choose the third and fourth options, leaving patients in the U.S. without access to potentially novel uses of well-established drugs. We call this the “cross-labeling problem” and we may now be heading toward a solution. Continue Reading