The Climate Action and Low Carbon Development Act 2015 (the Act) was signed into law on 10 December 2015. The Act comprises of a framework designed to achieve a low carbon, climate resilient, and environmentally sustainable economy by 2050. The Act provides for two statutory plans which will guide policy in relation to greenhouse gas emission reduction and climate change adaption. The plans are: 1) National Mitigation Plan; and 2) National Adaption Framework (NAF) ...
1 Which legislation sets out the regulatory framework for the marketing, authorisation and pricing of pharmaceutical products, including generic drugs? Which bodies are entrusted with enforcing these rules? The relevant legislation includes the following: • Law on Medicines 1996;
On April 19, 2016 Association of European Business (hereinafter – “AEB”) and the Russian Federal Antimonopoly Service (hereinafter – the “FAS”) presented the Code of Good Practice in the Pharmaceuticals Industry (hereinafter – the “Code”). The full text of the Code (both in Russian and English) is available at the official web-site of the antimonopoly authority (http://fas.gov.ru/documents/documentdetails.html?id=14513). Below is short outline of the Code. 1 ...
On April 18, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services issued revised guidance regarding exclusions imposed under section 1128(b)(7) of the Social Security Act ...
Responding to a Supreme Court mandate, the Environmental Protection Agency (“EPA” or “the Agency”) yesterday published a final supplemental finding that it is necessary and appropriate to regulate hazardous air pollutants emitted from coal- and oil-fired power plants under Section 112 of the Clean Air Act. 81 Fed. Reg. 24,420.Read the full alert ...
Entities that file disclosures with the Securities and Exchange Commission (“SEC”) should be aware of recent actions by regulators and shareholders questioning the sufficiency of opinion statements made in environmental-related disclosures. Most recently, on March 31, 2016, the SEC announced a settlement with Navistar International Corp ...
On January 4th, 2016, the President of the Republic introduced a series of amendments to the bill of law that, “modifies the Health Code in order to regulate generic bioequivalent pharmaceutical products and prevent the vertical integration of pharmaceutical laboratories and pharmacies”, – Bill No. 9914-11- (“Pharmaceutical Bill II”) ...
Increased deal activity is likely in Australia's health and aged care sector in 2016, driven by:• investment interest from China• Australian players targeting outbound opportunities through joint ventures and partnerships; and• consolidation in the aged and home care services areas.Rapidly ageing populations across our region are driving demand for high quality health care, especially in countries such as China and Japan ...
The High Court has delivered judgment in the case of Minch v The Commissioner of Environmental Information (CEI) (16 February 2016) concerning the scope of access to environmental information ...
The Modern Slavery Act 2015 introduces a new area of compliance for commercial organisations. The Act is amongst the toughest anti-slavery and human trafficking legislation in the world. Although legal penalties are restricted, interest from patients, consumers, investors, NGOs, pressure groups and brand risk is expected to enforce compliance ...
After a long wait, on February 12, 2016, the Centers for Medicare & Medicaid Services for HHS (“CMS”) issued a final rule that clarified the obligations of Medicare providers and suppliers to report and return overpayments within 60 days (the “Rule”).1 The Rule becomes effective on March 14, 2016. The Rule, which applies only to Medicare Part A and B providers and suppliers, enforces a statutory requirement from 2010 implemented by the Affordable Care Act (“ACA”) ...
Over the past year, the Tribunal administratif du Québec (TAQ) has issued several rulings dealing with oversight of the medical practice of professionals working in health and social services institutions. Several of these rulings will be of interest to institutions since they set out principles that tend to confirm the existence of a form of management rights over physicians, despite the lack of the traditional relationship of subordination between such institutions and their physicians ...
CMS and OIG Finalize Waivers for ACOs in the Medicare Shared Savings Program Effective October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health & Human Services (“HHS” or “the Department”) finalized the waivers of certain fraud and abuse laws to specified arrangements involving accountable care organizations (“ACOs”) in the Medicare Shared Savings Program (“MSSP”) ...
The Environmental Protection Agency (“EPA”) is embarking on a compliance initiative to ensure that sources that handle hazardous waste are complying with the Resource Conservation and Recovery Act (“RCRA”) requirements, particularly that sources are operating within their correct generator status, disclosing certain hazardous waste activities, and submitting required reports ...
On September 25, 2015, the Texas Board of Pharmacy (“TBP”) issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs. Currently, Texas regulations only allow for the substitution of lower-priced, generically equivalent drugs instead of certain brand name drugs. In contrast, the proposed rules allow pharmacists to dispense interchangeable biological products ...
In a short three-week period, the U.S. Department of Justice announced three large, multi-million dollar False Claims Act settlements involving Stark Law violations. Each of the three cases alleged that health systems compensated physicians in excess of fair market value, and in excess of collections for services personally performed by those physicians, in order to induce referrals ...
On August 18, 2015, the Tribunal administratif du Québec (TAQ) confirmed the decision of a health institution to not renew the status and privileges of one of its physicians after he refused to undergo refresher training to acquire skills that were necessary to perform his new duties.1 The physician in question, a hematology specialist, had been hired as a researcher several years ago ...
Environmental groups are attempting to enlist the U.S. Department of Commerce in their fight against fracking operations and climate change by petitioning DOC to ban natural gas exports under the Energy Policy and Conservation Act of 1975 (EPCA).To read the full alert, click here ...
The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in physical characteristics of a dosage form could affect patient compliance and acceptability of medication regimens, or could lead to medication errors. The main reason for the FDA’s guidance appears to be that many patients can experience difficulty swallowing tablets and capsules ...
On Monday, the Environmental Protection Agency (“EPA”) released its Clean Power Plan (“CPP”), the cornerstone of the Obama Administration’s multi-faceted regulatory approach to address climate change.1 The final rule is centered on reducing CO2 emissions from fossil fuel-fired power plants by 32 percent from 2005 levels by 2030 ...
Ahead of the recent election it was no secret that the Conservatives wanted to see a cut in taxpayer support for the development of wind farms. What did come as a surprise was the recent announcement by the Westminster Department of Energy and Climate Change (DECC) that the main form of subsidy for wind farms would suddenly be closed in March 2016 ...
In June 2015, the Superior Court of Québec sided with a real estate developer who applied for an order requiring the Quebec Ministry of Transport (MOT) to fix a highway interchange whose construction in 2007 caused the developer’s land to be flooded1. This article summarizes the court’s principal findings. The ruling has been appealed by the Quebec Ministry of Sustainable development, Environment and the Fight against climate change (MSDEF) ...
In a decision rendered on April 30, 20151, the Administrative Tribunal of Québec (the "ATQ") upheld a decision of the board of directors of a university hospital centre that refused to renew the status and privileges of a physician who failed to fulfill the obligations associated with the enjoyment of these privileges. Firstly, it should be noted that the applicant's clinical competence was not questioned in this case ...
Michigan vs. EPA, the Supreme Court continues to curtail EPA’s ability to regulate emissions from power plants by limiting the deference the Court will grant EPA on issues of statutory construction. In the 5 to 4 decision, authored by Justice Scalia and joined by Chief Justice Roberts and Justices Kennedy, Thomas, and Alito, the Court held that EPA’s air toxic standards for regulating mercury emissions from coal fired power plants were “unreasonable ...
