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Focus on Regulation

EDQM Publishes Draft Guidelines on Endotoxins, Pyrogens and Sterile Products

The European Directorate for the Quality of Medicines (“EDQM”) has published draft revisions to its Guidelines for Using the Test for Bacterial Endotoxins. Bacterial endotoxins are contaminants from gram-negative bacteria and are the most common cause of pyrogenicity in pharmaceutical products. The EDQM Guidelines explain the justifications for the requirements in the test for bacterial endotoxins. They also provide guidance on reading and interpreting test results.

The revisions are intended to clarify the existing Guidelines and bring these in line with current knowledge. In particular, the following revisions have been introduced to the Guidelines:

• A new section has been included on bacterial endotoxins. The amplification includes issues to be considered when establishing an endotoxin limit for a specific substance or product;

• A recommendation that a monocyte-activation test or test for bacterial endotoxins is preferred to the rabbit pyrogen test. This revision is intended to avoid the use of live animals and reflects the European Convention for the Protection of Vertebrate Animals used for experimental and other scientific purposes;

• A recommendation that a risk assessment be performed when using the bacterial endotoxin test as a pyrogenicity test. This is due to the potential for contamination by non-endotoxin pyrogens.

The draft Guidelines have been published on EDQM’s online publication, Pharmeuropa, and are available here. The draft revisions are open for comments from manufacturers, industry associations and other interested parties until 31 December 2014. Details on how to comment are available here.

New Charter in France for Pharmaceutical Promotion

The CEPS (French Health Products Economic Committee) and LEEM (French Pharmaceutical Industry Association) signed on 15 October 2014 a new Charter on information provided for promotional purposes via solicitation or prospection. This charter had been in discussions since 2013. It replaces and broadens the scope of the previous charter applicable to medical representatives’ activities.

The Charter sets out conditions under which employees of pharmaceutical companies, and their service providers, carry out solicitation and prospection activities in the context of the promotion of pharmaceutical products.

The Charter sets out conditions relating to:

  • the missions of the persons carrying out the promotional activities, and their supervision;
  • the quality of the information provided; and
  • ethics.

The conditions applicable to missions of the persons carrying out promotional activities are not fundamentally altered compared to the previous charter. A key innovation is the increased focus on off-label prescriptions. The authorities may require the companies to disseminate information reminding prescribers of the appropriate prescription of products, and this task can be allocated to the persons carrying out the promotional activities. These persons must also report any off-label practices that they have noted, which is consistent with the requirements imposed by French regulations on the industry as regards prevention of off-label prescription.

As regards the quality of the information provided, the Charter sets out a series of requirements which derive from advertising regulations and the French authorities’ recommendations. These relate in particular to the drafting of promotional documentation, use of scientific literature and comparative advertising. Ensuring the quality of the information also requires appropriate training of the persons dedicated to the promotional activities. The Charter provides details on the training requirements, and the manner in which the company must organise and document compliance with such requirements.

Ethics rules include conditions on how visits made to HCPs and to health institutions must be organized and implemented. The Charter also summarises restrictions and disclosure obligations applicable to hospitality, gifts and samples, in line with French anti-benefits and sunshine regulations. In addition to prohibiting the provision of samples of medicines, the Charter provides that samples of cosmetics products, food supplements and medical devices (except medical devices for evaluation purposes) cannot be handed over if the person is also promoting medicines.

The responsible pharmacist, as per the previous charter, has overall responsibility for supervising compliance with the Charter, including with regard to the content of the disseminated information and procedures put in place to ensure effective compliance with the Charter.

The Charter provides for a national observatory for promotional information established by the CEPS and LEEM. Companies will have to carry out an annual study aimed at measuring the quality of their promotional practices for their most promoted product (and up to 2 other products requested by the CEPS). The study data will be used to collate an annual report. The data collected will contribute to the CEPS assessment on limitations on the evolution of promotional activities that it may wish to impose on the industry (for certain pharmacotherapeutic groups or certain products).

The Charter is effective as from 15 October 2014. However, some of its provisions cannot be implemented as such right away: compliance with the Charter requires a certification by the companies with terms of reference set by the French National Authority for Health (HAS). The current terms of reference applicable to the previous charter will need to be updated to take into account the new Charter.

 

Court Finds Potential Personal Liability for a Company’s Import Violations

The U.S. Court of Appeals for the Federal Circuit has ruled in a new en banc decision that individuals employed by importers, or corporations that are not the “importer of record,” may be liable under civil penalty laws because of their role in introducing articles into U.S. commerce. This decision represents an important increase in the risk faced by individuals working for importing companies and other firms in the global supply chain.

Read More: Court Finds Potential Personal Liability for a Company’s Import Violations

Ninth Circuit Upholds Alameda County’s Safe Drug Disposal Ordinance

On September 30, 2014, a three-judge panel of the United States Court of Appeals for the Ninth Circuit unanimously affirmed the U.S. District Court for the Northern District of California’s August 2013 ruling in Pharmaceutical Research and Manufacturers of America (PhRMA), et al. v.  Alameda County, et. al., No. 13-136833, holding that Alameda County’s Safe Drug Disposal Ordinance is constitutional under the Commerce Clause of the U.S. Constitution.  The ordinance, which Alameda County enacted in 2012 and which is the first of its kind in the nation, requires pharmaceutical companies whose products are sold in Alameda County to establish, administer, and finance a drug take-back program for unused and unwanted medications.  The ordinance grew out of concerns that consumers have been disposing of drugs by flushing medications into wastewater systems where they allegedly can impact the environment.

A consortium of non-profit trade organizations representing the manufacturers and distributors of pharmaceutical products challenged the Alameda County ordinance under the Commerce Clause, under which states and localities may not unduly interfere with interstate commerce.  The Ninth Circuit rejected the plaintiffs’ argument under the Supreme Court precedents that apply a two-pronged approach to determine whether a state or local law violates the Commerce Clause.  Under the first prong, the Ninth Circuit had to determine whether the ordinance “either discriminates against or directly regulates interstate commerce.”  The court held that it does neither.  In the court’s view, the ordinance is not discriminatory because it treats all drug manufactures exactly the same regardless of where they are located, and it does not directly regulate interstate commerce because, as two stipulations between the parties revealed, the ordinance does not control conduct beyond the borders of Alameda County.  The court then moved onto the second prong, which required the court to assess whether the burden the ordinance imposes on interstate commerce is excessive when compared to the benefits it conveys on Alameda County.  The court, finding that the plaintiffs “provide[d] no evidence” that the ordinance will affect the interstate flow of goods, determined that it does not.  The court’s decision remains subject to appeal.

Alameda County began implementing the ordinance in July 2014 but is still working with companies to develop their required stewardship plans.  Although no product collection has been undertaken pursuant to the ordinance, absent a successful appeal, the Ninth Circuit’s recent decision clears the way for product collection to commence, likely sometime in 2015.  Implementation of a similar ordinance in King County, Washington, is expected to proceed as well.  Additional State and local governments across the country will undoubtedly consider adopting pharmaceutical take back programs as well and producer take-back programs for other products may not be far behind.  Producers will need to look closely at these programs to see if they are covered, and if so, will need to assess the most cost-effective means of achieving compliance.

FOIA: new research exemption comes into force

On 1 October, a new exemption (the “New Exemption“) relating to continuing programmes of research came into force under the Freedom of Information Act 2000 (“FOIA“).  Its intention is to protect information pertaining to on-going research from premature disclosure.

Section 22A FOIA – inserted by the Intellectual Property Act 2014 (“IPA“) – provides that information “obtained in the course of, or derived from, a programme of research” is exempt information if the following criteria are satisfied:

(a) the programme is continuing with a view to the publication, by a public authority or any other person, of a report of the research (whether or not including a statement of that information),  and

(b) disclosure of the information under [FOIA] before the date of publication would, or would be likely to, prejudice—

(i) the programme,

(ii) the interests of any individual participating in the programme,

(iii) the interests of the authority which holds the information, or

(iv) the interests of the authority mentioned in paragraph (a) (if it is a different authority from that which holds the information).

The New Exemption is not absolute, and a public authority seeking to rely on it will thus be required to assess whether the public interest in maintaining the exemption outweighs the public interest in disclosure.

The Ministry of Justice has published short guidance on the New Exemption. It notes, among other things, that its application is not limited to the first report that is based on the relevant research: “So long as any report of the research is still to be published, then information obtained in the course of, or derived from, the research programme falls within the scope of this exemption.”  The aim of the New Exemption is thus to protect information pertaining to such projects until they are fully concluded.

The New Exemption is both class- and prejudice-based.  So far as prejudice is concerned, in order for the New Exemption to be engaged public authorities will be required to demonstrate that the (now long-established) threshold is met, i.e. that:

(a) there is a causal link between disclosure and the prejudice claimed to one of the four factors set out in s. 22A(1) (b) (see above); and

(b) the prejudice is “real, actual or of substance”.

(see Hogan and Oxford City Council v Information Commissioner, EA/2005/0026).

In relying on the New Exemption, public authorities should be careful to assess, and state, the level of risk of the prejudice, and specify to the requester whether it considers that the prejudice “would” or “would be likely to” occur.  Failure to do so could ultimately lead the Commissioner or a tribunal in any subsequent appeal against a refusal to disclose the information to presume that the lower threshold applies (see ICO guidance on the prejudice test).

What constitutes a “programme of research” is not defined in FOIA, although the parliamentary discussion on the IPA demonstrates that the rationale for the New Exemption was to afford protection to academic research, much like the exemption in s. 27(2) of the Freedom of Information (Scotland) Act 2002 (David Willets, then Minister for Universities and Science, referred to the implementation of the “Scottish exemption”).  Nevertheless, in the context of collaborative programmes between public and private bodies, it will be interesting to see whether commercial entities will push public bodies to rely on the New Exemption alongside the protections already afforded by s.22 FOIA (information intended for future publication) and s.43 FOIA (commercial interest, including trade secrets).

Winnik International Telecoms & Internet Forum

Please join us for the third annual Winnik International Telecoms & Internet Forum, which will be held on 22 October 2014 at Hogan Lovells’ Washington, D.C. office. This forum brings together professionals from around the world for an afternoon of high-level discussion on current topics in international telecoms, media, and the Internet landscape. Please register using the link on the right.Hogan Lovells is hosting this forum in honor of our former partner Joel Winnik, who practiced international telecom law until his passing in 2012.


Agenda:

12:00 p.m. to 1:15 p.m.

Lunch and keynote address by Maureen Ohlhausen, Commissioner, Federal Trade Commission

 

1:15 p.m. to 5:30 p.m.

Panel discussions on hot topics including:

  • Spectrum Policy — Emerging Issues in Mobile Broadband and Wireless Services
  • Privacy, Cybersecurity, and Law Enforcement Access Issues for Connected Devices
  • Connected in Mobile Health
  • Internet of Things — Who Owns the Customer?

Guest panelists include:

  • Roger Sherman, Chief, Wireless Telecommunications Bureau
  • Dean Brenner, Senior Vice President for Government Affairs, Qualcomm
  • Michael Brown, Vice President of Security Product Management and Research, BlackBerry
  • Charlie Giordano, Chief Technology Officer for GE Healthcare Life Care
  • Kathleen Ham,  Vice President of Federal Regulatory Affairs, T-Mobile
  • David Jeppsen, Vice President of Business Development and Public Affairs, NTT DoCoMo USA
  • Julie Kearney, Vice President, Consumer Electronics Association
  • Danielle Kriz, Director of Global Cybersecurity Policy, Information Technology Industry Council
  • Harry Lightsey, Executive Director, Global Connected Consumer,General Motors
  • Jules Polonetsky, Executive Director & Co-Chair, Future of Privacy Forum
  • Tom Schaffnit, President, VII Consortium/Consultant to Honda

 

Cocktail reception — 5:30 p.m. to 7:30 p.m.

 

 

 

 

 

Register for the Forum

 

Date

22 October 2014

 

Time

12:00 p.m. to 7:30 p.m.

 

Click here for calendar appointment

 

Venue

Hogan Lovells

Fulbright Center – 13th Floor

Columbia Square

555 13th Street, NW

Washington, D.C. 20004

 

Click here for map

 

CLE certification

This program is pending approval for CLE credit in New York, Virginia, and California. For all other jurisdictions, attendees will receive a Uniform Certificate of Attendance.

 

Note to NY attorneys

This program is appropriate for both newly admitted and experienced attorneys.

 

Contact

For more information, please contact Hogan Lovells’ D.C. Marketing Team.

 

 

AWS-3 Auction Ownership Information

Last week, the Commission released the list of 80 applicants for the AWS-3 Auction, scheduled to begin November 13th.  From the names of the applicants, it is not always easy to tell what major telecom or investment companies have interests in the applicants.  We have done the hard work for you, reviewing the ownership disclosures for these 80 applicants.  Below, we provide the key ownership information, as well as links to the ownership disclosures, where available.

Continue Reading

UK MHRA SIMPLIFIES ADVERSE EVENT REPORTING IN CHILDREN

On 25 September 2014 the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) announced new simplified guidance for healthcare professionals reporting suspected adverse drug reactions (“ADR”) in children in the UK. Continue Reading

EMA OPENS CONSULTATION ON GUIDELINES FOR CORE SMPC FOR HUMAN PLASMA DERIVED PRODUCTS

On 1 October 2014 the European Medicines Agency (“EMA”) opened a consultation on revisions to its guideline on core summary of product characteristics (“SmPC”) for human plasma derived and recombinant coagulation factor IX products (the “Guidelines”).

The Guidelines are intended to provide harmonised guidance to applicants and regulators regarding the information that is to be included in the SmPC for human plasma derived and recombinant coagulation factor IX products, which are indicated for use in the treatment of prophylaxis of bleeding in patients with haemophilia B. Continue Reading

FTC Extends Deadline for TSR Comments

Today, the Federal Trade Commission (FTC) announced an extension of the deadline for comments on its Telemarketing Sales Rule (TSR).  The new comment deadline is November 13, 2014.  Among the issues the FTC is seeking comment on are whether the TSR’s pre-acquired account information provisions should be modified; what impact, if any, the increasing use of general media to solicit inbound calls to make purchases is having; and the costs and burdens of modifying the TSR’s recordkeeping requirements to require telemarketers to retain their own call records.

Hogan Lovells has a TCPA working group that includes more than 20 litigation, FCC/communications, and privacy lawyers with substantial experience in the TCPA and the FTC’s TSR.  For more information, please visit www.hoganlovells.com/tcpa.

The author wishes to thank Greg Oshel for his assistance in preparing this article.