Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent publication of the application decree to the “French Sunshine Act” by the French Ministry of Health.  “A Brave New World? The ‘French Sunshine Act’ imposes online disclosure of contracts with HCPs, as well as of payments of ‘advantages’ to HCPs, dating back to 01 January 2012,” written by Daniel Kadar, discusses the specific ways and means that health care companies must disclose agreements with and “advantages” (payment or hospitality, including payment of a contractual fee) provided to health care practitioners ("HCPs") in order to comply with the application decree.  Information to be disclosed dates back 18 months, to January 1, 2012, and the first disclosure requirement is set for June 1, 2013.  According to Mr. Kadar, this tight timeframe raises compliance issues and has industry calling for reconsideration.

• Print
• Comments
• Trackbacks
• Share Link

Reed Smith's Global Regulatory Enforcement blog features a post on a December 2012 French Supreme Court ruling in a case involving a French Director in a health care company who had been dismissed on the grounds of a clear breach of health care compliance obligations as set forth in the French Public Health Code. The outcome: even though a company is acting in a highly regulated environment such as health care, compliance breaches must be integrated in the employer-employee relationship if they are to justify termination in France. As Reed Smith Partner Daniel Kadar notes, this case serves as a reminder to any international health care organization that the worldwide adoption of compliance guidelines and of a Code of Conduct is not in itself a sufficient protection against compliance breaches – everything depends on how these tools are implemented locally.

• Print
• Comments
• Trackbacks
• Share Link

InsideCounsel recently published, "E-discovery: The need for a transnational approach to cross-border discovery disputes," an article on international discovery issues and the benefit of a respectful approach to document productions outside of the U.S.  Written by Reed Smith Records & E-Discovery Group members David R. Cohen, Regis W. Stafford, Jr. and Caitlin R. Gifford, the piece notes that proposed EU Data Protection Directive regulations have the potential to subject multinational companies to sanctions of up to two percent of annual worldwide revenue for serious breaches, including unlawful data transfers to the U.S.  In addition, although not binding on U.S. courts, the ABA recently issued a resolution and recommendation that states in part that U.S. courts should “consider and respect the data protection and privacy laws of any foreign sovereign..."  This article underscores the importance of a comprehensive global approach to document production in cross-border litigation.

To be invited to future Reed Smith trainings on cross-border e-Discovery issues, please click here.

• Print
• Comments
• Trackbacks
• Share Link

The REACH Regulations established a new system for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in the European Union when implemented on June 1, 2007. With phased implementation over an 11-year period, REACH covers chemicals, and substance mixtures, and articles that contain substances that are manufactured or imported into the EU in certain minimum quantities.

Statistics on the pre-registration phase give a clear indication that REACH's reach has been longer than expected: The European Chemical Agency (ECHA) anticipated that approximately 30,000 chemical substances would be pre-registered, but in the end closer to 150,000 substances were pre-registered.

Nick Elliott's article, "The Next Steps," published in a recent edition of Hazardous Cargo Bulletin, discusses this new EU chemical regime, what companies need to do next, and some of the pitfalls to be avoided. The first registration deadline, applicable to high-volume and high-risk chemical substances, is only 18 months away – November 30, 2010. As Elliott explains, potential registrants have no time to waste in order to ensure compliance with the REACH registration obligations. REACH potentially impacts not only the EU chemical industry but also any entity, such as those operating in the life sciences industry, that manufactures in or imports substances/products into the EU.

• Print
• Comments
• Trackbacks
• Share Link

The European Court of Justice ("ECJ") recently had the opportunity to opine on limits on the scope of advertising for medical products in the European Union, when a journalist who had reprinted factual information about a pain medication sold in Norway but prohibited in Denmark, was made an example under Danish legal provisions prohibiting advertising for medicinal products that are not lawfully marketed in Denmark. As exmplained by Paule Drouault-Gardrat, Julie Gottenberg and Juliette Peterka in "Advertising of medicinal products versus freedom of expression of a journalist - European Court of Justice Decision dated 2 April 2009 (C-421/07) 'Frede Damgaard' " (available also in French), the ECJ concluded the issue was a matter for the national court in the first instance, relying in part on a line of French cases holding that any publication praising the merits of a medicinal product must be considered as advertising whomever its author, regardless of whether the manufacturer sought or paid for publication.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Judith L. Harris and Amy S. Mushahwar.

The Federal Communications Commission (“FCC”) recently released an Order allocating 2 MHz of new spectrum for advanced wireless implanted devices, which may enable the certification of new devices by the FCC’s Office of Engineering and Technology.

The FCC also seeks comment on a proposal to allocate up to 20 MHz of spectrum for implanted neuromuscular micro stimulators. This additional allotment for electronic stimulation technologies could be used to develop devices for the medical treatment for millions of people living with brain and spinal cord injuries and neuromuscular disorders.

Parties interested in registering new devices under the FCC’s Order or in commenting on the additional spectrum allotment for electronic stimulation technologies are encouraged to contact Judith L. Harris or Amy S. Mushahwar.

For additional information, please see Reed Smith's full alert.

• Print
• Comments
• Trackbacks (1)
• Share Link

This post was written by Paule Droualt-Gardrat, Juliette Peterka and Julie Gottenberg.

On December 10, 2008, the European Commission published a series of political measures and legislative proposals, the so-called “Pharmaceutical Package.” This series included the “Communication on a renewed vision for the pharmaceutical sector,” which reflected on ways to improve market access and develop initiatives to boost European Union (“EU”) pharmaceutical research. Through the Pharmaceutical Package, the European Commission aims to make pricing and reimbursement more transparent, increase the development of pharmaceutical research within the EU, improve the safety of medicines worldwide, and reinforce cooperation with international partners.

The European Commission has published three separate sets of proposals amending Directive 2001/83/EC on the Community Code of medicinal products and Regulation 726/2004 on medicinal products obtained through centralized procedures:

1.  A proposal amending Directive 2001/83 as “regards information to the general public on medicinal products subject to medical prescription” (Information to patient);
2.  A proposal amending Directive 2001/83 and a proposal amending Regulation 726/2004 as “regards pharmacovigilance” (The EU pharmacovigilance system); and,
3.  A proposal amending Directive 2001/83 as “regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source” (Counterfeit Medicines).

Read Reed Smith's full alert outlining proposed amendments to Directive 2001/83/EC and Regulation 726/2004.

• Print
• Comments
• Trackbacks
• Share Link

This article, written by Reed Smith attorneys Paule Drouault-Gardrat and Juliette Peterka, was first published in Insights, the conference bleue newsletter.  Reprinted with permission.

Article 21 of the Regulation No. 1924/2006 on nutrition and health claims made on foods of 20 December 2006 provides data protection for applicants who wish to register a nutritional or health claim not included in the Community list. The Community list of authorized health or nutrition claims will be established on the basis of proposals made by Member States with the assent of the Commission before 31 January 2010.

The difficulty is that if a manufacturer wants to use a claim which is not listed, it will have to proceed to a scientific evaluation of the claim. This raises two types of issues. Firstly, this is quite expensive. Consequently, this will cause small and middle sized companies to increase their costs every time they consider using a new claim. The second issue relates to the protection of the company’s private data. The Commission thus decides to provide data protection to new applicants, under Article 21 of the Regulation No. 1924/2006.

• Print
• Comments
• Trackbacks
• Share Link

Markets outside the United States are increasingly important for life sciences companies, and this post includes articles by Reed Smith lawyers regarding two developments in Europe. 

The first is by Edward Miller, entitled "Sidestepping the Issue", republished with permission from the International Clinical Trials e-book (registration required).  This article discusses a ruling by the European Court of Justice, holding that pharmaceutical companies can refuse to fill "unusual" orders from distributors who seek to profit by buying drugs for countries with low reimbursement prices, and shipping them for sale in countries with high prices - but falling short of the standard advocated by the pharmaceutical company defendant in that case. 

The second article is by Paule Drouault-Gardrat and Julie Gottenberg regarding French Supreme Court rulings earlier this year on causation in product liability cases.  First published in the August edition of Insights, the conference bleue newsletter, the article is reprinted with permission here:

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Paule Drouault-Gardrat and Julie Gottenberg.

Under French Law, pharmacies benefit from a monopoly on the sale of medicinal products. This monopoly covers reimbursed and non-reimbursed pharmaceutical products. Once they are de-reimbursed, the price setting is free. This is indeed a very important market for the approximately 23,000 French pharmacies, as the current government follows a policy of dereimbursement.

• Print
• Comments
• Trackbacks
• Share Link

At EU level, there are essentially two routes to obtaining an authorization from the EMEA to place a product on the market more quickly than through the usual marketing authorization route. The first is an application for a conditional authorization that is available where clinical trials have not been fully completed. This is not a full marketing authorization, but, as its name suggests, has conditions attached. The intention is that once the conditions are fulfilled, the authorization can become a full and unconditional marketing authorization. The other route is through an application to the EMEA for an accelerated or exceptional authorization. For this application, full data is available and a full marketing authorization is obtained, but the decision-making process occurs more quickly. In addition to these EU routes, some individual member states have their own legislation allowing products, subject to controls, to be marketed without a full marketing authorization in specified circumstances. This national legislation is the subject of a harmonizing guideline issued by the EME¹, although significant differences still remain in how the member states operate these compassionate-use programmes.

• Print
• Comments
• Trackbacks
• Share Link

This post was written by Darren Smith, Julia Dodds, and Claire Hamm.

The UK has an estimated 3,000 deaths per year from mesothelioma, the lung cancer caused by inhalation of asbestos fibres. This rate of incidence shows no signs of slackening, a result of the historic exposure of the UK workforce to asbestos, and is not expected to peak until 2018. With the average award of damages for mesothelioma currently around £150,000 ($300,000), defendants and their insurers are already paying out close to $1 billion a year to settle mesothelioma claims alone; and to this must be added the cost of claims for non-fatal asbestos-related diseases.

• Print
• Comments
• Trackbacks
• Share Link