Within the agricultural and food supply chain, significant imbalances in bargaining power between suppliers and buyers of agri-food products are frequent. Those imbalances in bargaining power are likely to lead to unfair trading practices. The Directive 2019/633 (the “Directive”) aims to ensure that agri-food companies are protected against these unfair practices. Scope of the Directive The Directive’s scope is very limited ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
To help further the objectives of the Women’s Health Strategy for England (published by the Department of Health and Social Care in July 2022) £1.97m has been awarded to help women in the workplace who are experiencing reproductive health issues. The grant will be shared between 16 charities which include, amongst others, Fertility Network UK, Sands, Tommy’s and Mind ...
On Jan. 19, 2021, the two recent final rules issued by the Department of Health and Human Services Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) regarding changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law) regulations (respectively the OIG Rule and the CMS Rule, collectively the Final Rules) became effective ...
Governor Ivey in her State of the State address on February 4 argued forcefully that Alabama must do more to attract physicians (and nurse-practitioners) to practice in the rural, under-served areas of the state. Unfortunately, one of the only current tax incentives to do so—a $5,000 income tax credit that can be claimed over a 5 consecutive year period--has been the source of many audits and administrative and Alabama Tax Tribunal appeals ...
Last week, the U.S. Department of Labor (DOL) issued proposed rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer association to provide health coverage for their employees ...
Law no.11/2012 of 8 March establishes new rules for prescription and dispensing of medicines. Prescriptions for medicines must now include the International Nonproprietary Name (INN) of the active substance,its pharmaceutical form, the dosage, the presentation and the posology. The prescription may also include a trade name by brand or indication of the name of the holder of the marketing authorisation ...
On January 24, 2011 the Attorney General of the Federal Republic of Brazil signed a document restricting the powers of ANVISA (Brazil’s regulatorybody) in the examination of pharmaceutical applications, giving the rights to the Brazilian PTO to do so without any interference of ANVISA. The dispute between ANVISA and the Brazilian PTO in the examination of pharmaceutical applications had apparently been solved ...
Due to the non-renewal of the constitutional state of exception of catastrophe, the health authority modified the Covid-19 regulations. The main changes are mentioned below: A. STEP-BY-STEP PLAN MODIFICATION On October 1st 2021, Exempt Resolution No. 994 was published in the Official Gazette, which regulates and establishes a new version of the “Step-by-Step Plan” ...
In 2016, the Centers for Medicare and Medicaid Services (CMS) issued regulations that prohibited long-term care facilities from entering into pre-dispute arbitration agreements with residents and their families. Shortly thereafter, those regulations were successfully challenged in federal court, and CMS has not attempted to enforce them. On July 18, 2019, CMS issued a final rule that will formally rescind the ban on pre-dispute arbitration agreements with long-term care residents ...
The Ministry of Economy published the new proposed Regulation on Price Information per Unit of Measurement of Products (Decree No. 229 of 2002), which seeks to improve the transparency and quality of the information provided to consumers regarding the prices of products both in physical stores and online, so that they can make informed purchasing decisions and promote fair competition in the market ...
For many years, nurses in Ohio were only required to disclose convictions to the Ohio Board of Nursing on their biennial license renewal application. However, a new regulation from the Ohio Board of Nursing now requires licensees to additionally report a guilty plea, conviction or treatment in lieu of conviction of certain crimes within 30 days of the plea or entry ...
The Ministry of Health has published a new public consultation process regarding proposed modifications to the Preliminary Titles; II "Food"; XXVII "Of Alcoholic Beverages, Fruit and Vegetable Juices and Bottled Waters"; and XXIX “Of the Food Supplements and Foods for Athletes” of Decree No. 977/1997 that establishes the Sanitary Regulations for Foods (hereinafter, “ RSA ”) ...
The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains. This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies ...
The Federal Council of Pharmacy published Resolution No. 658/2018 to regulate publicity, advertisement and announcement of activities related to the pharmaceutical profession. Such include any disclosure arising or promoted by pharmacists, regardless of the means of communication ...
On July 1, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule[1] outlining financial penalties, referred to as “disincentives” throughout the rule, for healthcare providers that engage in conduct that is considered “information blocking.” The 21st Century Cures Act defines information blocking as a “practice that interferes with, prevents, or materially discourages access, exchange, or use of electronic health information ...
December 2, 2022 By: Anna G. Thomas To increase transparency regarding payments to physicians by drug and medical device companies, Governor Newsom signed AB 1278, which imposes certain additional disclosure obligations on physicians. Beginning on January 1, 2023, physicians will be required to comply with new patient notice and posting requirements. Notice to Patients Under this law, physicians must provide to patients an Open Payments database notice ...
The Office of Inspector General (OIG) has issued a favorable advisory opinion addressing an investment in an ambulatory surgery center (ASC) made by a health system, certain physicians employed by the same health system, and a management company. OIG Advisory Opinion No. 21-02 is the first advisory opinion since 2009 to provide guidance on ASC investments and related safe harbors to the Anti-Kickback Statute ...
Recently, the Ohio Department of Medicaid (ODM) finalized Ohio Administrative Code 5160-1-32.1 (the Final Rule) which provides two standard authorization forms for the use and disclosure of protected health information (PHI). The standard forms are designed to comply with both the HIPAA Privacy Rule (45 C.F.R. § 164.508) and 45 C.F.R. Part 2, which covers certain substance abuse treatment information ...
Beginning March 19, 2019, naltrexone drug products, including Vivitrol, dispensed pursuant to an outpatient prescription and indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence must be reported to the Ohio Automated Rx Reporting System (OARRS) ...
Key Points Governor Newsom signed into law Assembly Bill (AB) 133, which creates a $750 per day civil money penalty for skilled nursing facilities (SNF) that do not comply with a transfer, discharge, or readmission hearing decision within three calendar days. AB 133 also requires an SNF to submit a certification of compliance to the Department of Health Care Services (DHCS), attesting it has complied with the hearing officer's order ...
On December 2, 2022, President Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (“Marijuana Research Act” or “Act”) into law. The Act aims to help facilitate research on marijuana, directs the Drug Enforcement Administration (DEA) to follow new procedures to register practitioners to conduct marijuana research, and improves the supply of marijuana for research ...
Below is a summary of key new measures that have been implemented by various UAE authorities since 30 April 2020 and the time of this inBrief, 12:00 noon on Thursday, 7 May 2020. I. Economic Relief Measures A ...
Below is a summary of key new measures, as well as clarifications on previous measures we reported on, that have been implemented by various UAE authorities since 5 April 2020 and the time of this inBrief, 6:00 p.m. on Tuesday, 7 April 2020 ...
