A reputation for counterfeiting, poor quality control, ever-changing and inconsistent application of regulations and the challenges of ensuring that development does not unduly prejudice the welfare of the general population - this description of China’s pharmaceutical industry is representative of much that is good, bad and challenging in China’s recent regulatory and economic development ...
Pursuant to the Act on Drugs, the Ministry of Health of the Slovak Republic has specified in annexes to this Decree details on forms to be used for prescriptions of drugs and medical aids. By this Decree, the Ministry also has set the sample forms of medical prescription, special medical prescription, medical reference, and extract from medical prescription, order and special order ...
The federal Pipeline and Hazardous Material Safety Administration (PHMSA) has proposed new regulations for rural onshore low stress pipelines and rural onshore gathering lines. Although PHMSA has been anticipating further regulation of these types of lines for the past few years, the Agency acknowledges that the proposed rule is a direct response to legislative and media scrutiny of recent incidents that occurred in the Alaska Prudhoe Bay field ...
As the poultry farming crisis looms and countries are on the lookout for outbreaks of infection, scientists are closely following the evolution of the virus, which is moving to new sources of infection.Before a crisis is on our doorstep, businesses should prepare themselves for the consequences of a high rate of absenteeism. Without exaggerating the risks, they should adopt preventive strategies and become aware of the legal ins and outs of their actions ...
Interdisciplinary collaborations and partnering across the medical research and life sciences sectors are becoming increasingly common. Large corporations with good industry reputations and large research budgets are seeking to collaborate with smaller companies developing next-generation products. Equally, smaller companies are coming together to share complementary know-how and technologies and to work together in the global marketplace ...
ALERT Hospital May Be Excluded For Physician Recruiting On May 8, 2006 the OIG announced that it intends to exclude San Diego-based Alvarado Hospital from participation in Medicare, Medicaid and all other federal health care programs because of payments the Hospital made under relocation agreements involving placement of newly-recruited physicians in established physician practices ...
Certificate of Need Strategies for New Nursing Home Beds Special Population Beds are Re-Approved At its March 2006 meeting, the Michigan Certificate of Need (“CON”) Commission took action to re-approve several state-wide pools of nursing home beds that are set aside to serve special populations, including: Alzheimer’s Use 60 beds Hospice 30 beds Religious Use 20 beds The Commission reserved 22 special population beds on a non-specified basis for future use ...
IN OUR JUNE 2005 “FDA WATCH” column, we provided an overview of the regulatory, political, and scientific landscape for follow-on biological products in the U.S. As reported a year ago, the biogenerics debate centers around whether generic biologics are scientifically possible (i.e ...
Scope of this treatiseThe purpose of this discussion is to address those cases which are most likely to have a significant effect for those practicing in the chemical, pharmaceutical and biotech areas ...
In April 2005 a new Disability Discrimination Act was passed by Westminster. The Act extends existing non-discrimination legislation, primarily the Disability Discrimination Act 1995. While some provisions of the Act came into force in December 2005, many others will be coming into force over the course of 2006. It is essential that businesses are aware of their new responsibilities under the Act and prepare for its implementation ...
Judgement of the European Court of Justice in case C-212/03 – Commission v. France, dated 26 May 2005 The Commission acted against France on the grounds that certain French rules on the importation of medicines are contrary to Article 28 of EC Treaty on the free movement of goods. The relevant national rules and administrative practice required a licence for the importation of medicines for personal use in France ...
On June 28, 2005, amendments to Articles 420 and 421 as well as the addition of a new Article 414bis of the Health Law were published in the Federal Official Gazette, entering into force the following day. Article 414bis provides that herbal products, food supplements, perfumes and beauty products may be seized, as a precautionary measure, when they have been improperly advertised by being held out as medicines or as having characteristics or therapeutic qualities which they do not have ...
Judgments of the European Court of Justice in Merk, Sharp & Dohme BV v. Etat Belge (C-245/03) and Glaxosmithkline SA v. Etat Belge (C-296/03) of 20 January 2005 Directive 89/105, on the transparency of medicines pricing and reimbursement rules (hereinafter the “Directive”) was first interpreted in 2001 and 2002, when the European Court of Justice (hereinafter the “ECJ”) rendered two decisions regarding the implementation of the Directive in Austria and in Finland ...
Introduction: On June 9, 2005 the Supreme Court of Canada released its landmark decision in Chaoulli v. Quebec (Attorney General) in which a majority of the Court struck down provisions of Quebec’s Health Insurance Act and Hospital Insurance Act which prohibit private insurance for health care services that are available in the public health care system ...
On May 20, 2005, the Supreme Court issued its judgment in the Smith & Nephew Inc. v. Louise Glegg and Christopher Carter and Gilles Dextradeur v. Louise Glegg cases1 ...
Introduction Advocate General Jacobs, in delivering his Opinion in Syfait and others v Glaxosmithkline (Case C-53/03, 28 October 2004), has found in favour of Glaxosmithkline (GSK) by stating that the refusal by a dominant pharmaceutical company to fulfil all orders from wholesalers does not automatically constitute an abuse of a dominant position, despite such refusal clearly limiting parallel trade of the products in question ...
In November the UK government bowed to pressure from unions and bereaved relatives and announced its intention to produce a draft bill on corporate killing for England and Wales. This bill, if successful, would have enabled companies to be prosecuted for management failures that resulted in a person's death. No such government bill has however, been forthcoming. Nor is it likely that any such government bill will appear before the 2005 general election ...
In late October, the IRS released a revised version of its 1023 Form. The new Form requires extensive new disclosures by organizations that seek recognition of tax-exempt status as charities under Section 501(c)(3) of the Internal Revenue Code. Many of the questions added to the exemption application are likely to be included in revised Form 990 information returns scheduled to be released later this year ...
The Impact of Business Associate Rules Under the Final Privacy and Security Standards Presented at: Negotiating Technology Outsourcing Agreements Law Seminars International Seattle, Washington Introduction The Health Insurance Portability and Accountability Act of 1996, more commonly known as HIPAA, has brought many changes to the health care field, as well as our day-to-day lives ...
Authors Karen Williams Altaras Mary Jean Geroulo E. Earl Harcrow Jeffrey P. King Lewis A. Lefko Thomas William Mayo Lisa Schafroth Sooter Related Practice Groups Health Care Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments ...
Healthcare Legislative Update - 78th Regular Session July 2003 © 2003 – Haynes and Boone, LLP Haynes and Boone, LLP 901 Main St., Suite 3100 Dallas, TX 75202 You have accessed the Healthcare Legislative Update for the 78th Regular Session of the Texas Legislature. This update has been compiled by the Health Care Section of Haynes and Boone LLP for use as a quick reference tool on topics that we believe that will be of interest to our clients and the healthcare industry ...
Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments. Out-of-network providers scored a legislative victory as Medicaid managed care organizations will have to pay them regular Medicaid rates if use of their services exceeds new benchmarks ...
Authors Karen Williams Altaras Mary Jean Geroulo E. Earl Harcrow Jeffrey P. King Lewis A. Lefko Thomas William Mayo Lisa Schafroth Sooter Related Practice Groups Health Care Prompt payment by managed care organizations is once again a hot topic of debate as revisions of current law and regulations deals with claim submission deadlines, recoupment practices, prompt pay penalties, eligibility verification and underpayments ...
On October 16, 2003, the Health Insurance Portability and Accountability Act (“HIPAA”) requires employer-sponsored group health plans and others to be in compliance with the Transaction and Code Sets (“TCS”) standards for electronic transactions adopted by the Department of Health and Human Services (“HHS”). The federal government has been warned of potential disruption in the claim submission and payment cycles because the health care industry remains substantially non-compliant ...
With the passing of April 14, 2003, large health plans (those with more than $5,000,000 in annual receipts) became subject to the privacy regulations issued under the Health Insurance Portability and Accountability Act (HIPAA). However, more HIPAA deadlines loom on the horizon ...
