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

This post was written by Hugh T. Scogin, Gordon B. Schatz, Amanda Tao and Amanda Yang .

The Chinese government officially launched the National Essential Drug System (NEDS) Aug. 18, 2009 at a press conference held by the State Council, during which it explained the concentration of specific drug purchases in urban and county grass-roots health institutions as the first step in the implementation of NEDS. By 2009, NEDS will be implemented in 30 percent of government-run urban and county health care institutions in each province, region, or municipality. NEDS could have significant implications for the marketing, sale, distribution, and pricing of drugs by multinational and Chinese pharmaceutical companies in China.

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This post was written by Hugh Scogin, Gordon Schatz, Amanda Tao and Amanda Yang.

On May 20, 2009, China's State Administration of Industry and Commerce, the Ministry of Health, and the State Food & Drug Administration together issued new regulations for medical device manufacturers and distributors who advertise medical devices and diagnostic products, entitled, "Measures for the Examination of Medical Device Advertisements" and "Standards for the Examination and Release of Medical Device Advertisements." To read a summary of key points contained in the regulations, click here.

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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.

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Over the centuries, many have sought better opportunities in the United States. For the last few years, tort plaintiffs have been among them. Companies in many industries have been the target of lawsuits filed by plaintiffs who live outside the United States, over injuries that also allegedly occurred elsewhere, whether because of perceived advantages in substantive law within the United States, or access to procedural devices in U.S. courts that are not widely available in the rest of the world (such as the class action device).

In a May 1 opinion by Judge Posner filed in two consolidated appeals, Abad v. Bayer Corp. and Pastor v. Bridgestone/Firestone North American Tire, LLC, the Seventh Circuit affirmed dismissal of two cases on grounds of forum non conveniens. In both cases, the plaintiffs are Argentine citizens who live in Argentina and allegedly were injured there, but filed product liability lawsuits against American manufacturers in U.S. district courts. Under the familiar forum non conveniens doctrine, the district courts had weighed various factors and concluded in both cases that Argentina was better-suited to decide plaintiffs' lawsuits -- Abad being a 600-plaintiff class action in which hemophiliacs contended they contracted the AIDS virus from the defendant's clotting factor, and Pastor an auto accident rollover case involving allegedly defective tires.

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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.

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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.

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This post was written by Sharon J. Mann, Hugh Scogin, Gordon B. Schatz and Amanda Yang.

At the 2nd Session of the 11th National People’s Congress (NPC) convened on March 5, 2009, China’ Premier Wen Jiabao confirmed the major contents of the healthcare reform in the 2009 Government Work Report. On January 21, 2009, the State Council approved the Opinions on Advancing Healthcare Reform and the Implementation Plan on Advancing Healthcare Reform 2009-2011 in principle. The opinions and the plan are expected to be published after the NPC session, with the Government Work Report representing the first government document that confirms work focuses in the coming healthcare reform program.

According to the Work Report, the Chinese government will spend US$124 billion (850 billion RMB) on healthcare reform between 2009 and 2011, including 331.8 billion RMB from the central government. The funds will be used in five primary areas 1) medical insurance, 2) essential medications, 3) basic healthcare service systems, 4) equal access to basic public health services, and 5) reform of public hospitals.

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

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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.

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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.

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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:

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On October 22, 2008, the Government Accountability Office (GAO) issued a report entitled "Drug Safety: Better Data Management and More Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection Program." Among other things, the GAO found that: FDA databases contain inaccurate information on foreign establishments subject to inspection; FDA inspects relatively few foreign establishments each year to assess the manufacturing of drugs currently marketed in the United States; and FDA’s identification of serious deficiencies has led foreign establishments to take corrective actions, but inspections to determine continued compliance are not always timely. The GAO recommends that FDA improve the data that it uses to manage its foreign inspection program, conduct more inspections of foreign establishments, and ensure more timely inspection of foreign establishments where FDA has identified serious deficiencies. HHS agreed that FDA should conduct more foreign inspections, and discussed other FDA oversight initiatives, such as database improvements.

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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.

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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.

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On March 14, 2008, the U.S. Food and Drug Administration (“FDA”) received approval from the U.S. State Department to place eight full-time, permanent FDA employees at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government. The FDA will also be hiring five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou. The FDA expects to be fully staffed in China within 18 months.

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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.

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It seems like a rare day when there is not a notice of a foreign-made defective product being recalled in the United States. In recent months, there have been more than 500 recalls of a variety of products including millions of toys coated with lead paint, thousands of illegal fireworks, contaminated meats, and tainted medicines.

The issue has become so enormous that the U.S. Government has created a website—www.recalls.gov—that provides information about recalls coordinated by a variety of agencies including the Consumer Product Safety Commission, the Food and Drug Administration, U.S. Department of Agriculture, the Environmental Protection Agency, and others.

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