Archives: International Life Sciences

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The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

The Food and Drug Administration (FDA) has issued a notice announcing the availability of a draft guidance document clarifying its acceptance of medical device clinical data from studies conducted in countries other than the United States. The document is intended to provide guidance regarding the 2012 Food and Drug Administration Safety and Innovation Act § 1123, amending Food, Drug & Cosmetic Act § 569B, which codified FDA's policy of accepting scientifically-valid clinical data obtained from non-U.S. clinical studies in support of premarket submissions for medical devices.… Continue Reading

Toward Class Actions for Health-Related Claims in France

The French government issued a bill on March 17 for the extension of class actions to health-related claims in France. Starting today, March 31, the text will be discussed at the French National Assembly, particularly to address the issue of compensation for personal injury within the framework of the proposed class action.… Continue Reading

Erroneous Country of Origin Determinations May Result in Significant FCA Penalties for Medical Device Companies

Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading

French Sunshine Act’s Scope Expands with Recent French Supreme Administrative Court Decision

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading

In-House Lawyers in France Remain without Legal Privilege

French Minister for Economic Affairs Emmanuel Macron recently introduced a bill proposing the recognition of legal privilege for in-house lawyers in France, which does not currently exist. However, this recognition was rejected by the Special Commission of the French National Assembly before the bill was passed by the lower chamber - a decision consistent with the Grand Chamber of the European Court of Justice's 2010 ruling in Akzo.… Continue Reading

Public Consultation Examines Potential Confidentiality Issues with New European Clinical Trial Regulations

Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As … Continue Reading

Law360 Article – U.S. and French Sunshine Laws Present Compliance Challenges for Manufacturers

In “From Sea to Shining Sea: French and US Sunshine Laws,” (Law360 subscription required), Reed Smith attorneys Elizabeth Carder-Thompson and Daniel Kadar discuss recent legislation from both sides of the Atlantic designed to increase the transparency of relationships between drug and medical device manufacturers on one hand and physicians and teaching hospitals on the other. … Continue Reading

China’s Medical Device Regulations Receive Notable Revisions

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the New Regulation). The State Council Legislative Affairs Office worked more … Continue Reading

Do You Know Where Your Pharmaceuticals Are From? Navigating the “Country of Origin” Question for Pharmaceutical Products

Drug and medical device manufacturers are often faced with difficult challenges in determining the country of origin for their products, which are often sourced, processed and manufactured in multiple countries. As detailed by the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, there are a variety of factors that must be taken into consideration when answering the country of origin question for a pharmaceutical product - chief among which is who is asking the question. This article provides an overview of the principal regulatory schemes and their country of origin standards in order to help provide clarity to pharmaceutical companies in an often confusing and frustrating process.… Continue Reading

UK Government Addresses Lack of Regulation and Legislation in Cosmetics Industry

In April 2013, an independent review of the regulation of cosmetic interventions in the UK was published, highlighting an insufficient amount of regulation in this industry by the UK government, due in part to the rapid growth of cosmetic procedures in the United Kingdom. Cases such as unauthorized (and potentially defective) materials being used in … Continue Reading

A Comparison of the U.S. and French Sunshine Reporting Requirements

This past year both the U.S. and France enacted substantial new reporting and disclosure requirements under their respective Sunshine Acts, which were designed to increase the transparency of the financial relationships between manufacturers and health care professionals and to allow patients to make more informed decisions regarding their health treatments. The U.S. and French Sunshine … Continue Reading

EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector; NHS Advocates Selling Confidential Patient Data For Secondary Purposes

Reed Smith’s Global Regulatory Enforcement Law blog features two posts of interest to those in the life sciences industry, both written by Reed Smith partner Cynthia O’Donoghue. “EU Research Group Condemns EU Regulation for Restricting Growth in Life Sciences Sector” discusses the opposition of a lobbying group, led by the Wellcome Trust, to amendments to … Continue Reading

New UK Pharmaceutical Packaging Warnings: Lucy in the Sky with Directions for Marketing Authorisation Holders

The UK Medicines and Healthcare Products Regulatory Agency has directed Marketing Authorisation Holders (MAHs) for medicines containing specified controlled drugs to update their Summary of Product Characteristics, patient information leaflets, and product labeling. These new warnings are designed to make it easier for the government to enforce a new law prohibiting driving under the influence … Continue Reading

China Issues New Regulations Prohibiting Commercial Bribery in the Health Care Industry

This post was written by John Tan, Amy Yang, and Crystal Xu. In late December, China’s National Health and Family Planning Commission (NHFPC), the successor organization to the Ministry of Health, issued two sets of anti-corruption regulations for the health care industry: the 2013 Regulations on the Establishment of a Commercial Bribery Blacklist for the … Continue Reading

Launch of the New French State Portal Allows for Electronic Information Disclosure by Health Care Companies

Reed Smith’s Global Regulatory Enforcement Law blog features a post on the recent launch of the new state portal in France. "The implementation of the French transparency regulation: first good news?," written by Reed Smith partner Daniel Kadar, discusses how the portal will allow health care companies to more easily disclose transparency information to the French government … Continue Reading

Planes, Trains and Over-the-Counter Pills

This post was written by John Wilkinson, Nicola Maguire and Adam Lewington. In November 2013, the Human Medicines (Amendment) (No.2) Regulations 2013 (the “Amendment”) came into effect, amending the Human Medicines Regulations 2012, which set out a “comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and … Continue Reading

Long Delays Still Expected for TSRA License Applications

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a post about the U.S. Treasury Department’s Office of Foreign Assets Control’s review of applications filed under the Trade Sanctions Reform and Export Enhancement Act of 2000. Although restrictions on the export and re-export of some medical devices and medicines were lifted a year ago, license … Continue Reading

China’s Life Sciences Regulatory Crackdown: September 10 Update

The regulatory enforcement environment in China remains tense, as both the Chinese government and media bring new actions and allegations against life sciences manufacturers in both the pharmaceutical and device sectors. We are seeing: Increased attention to medical device sector Enforcement actions spreading to smaller cities Continued pressure on pharmaceutical sector Reports of misconduct by … Continue Reading

China: Life Sciences Regulatory Crackdown Spreads to Medical Device Sector

On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical equipment in Beijing. In its announcement, the Beijing MOH noted that prior inspections of hospitals had found continuing problems with the misuse and overuse of medical devices to increase profits. The investigation is intended to strengthen hospitals' management of the use of medical devices and to regulate the use of high value medical consumables.… Continue Reading

China Life Sciences and Health Industry Client Briefing – May/June 2013 (July 12, 2013)

This post was written by Katherine Yang, Amy Yin, Vicki Lung, Gordon B. Schatz, Jay J. Yan, John J. Tan, Mao Rong and May Wong. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health … Continue Reading
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