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 Esso Australia Pty Ltd v The Australian Workers' Union [2015] FCA 758, the Federal Court upheld the validity of some, but not all, orders made by the Fair Work Commission (FWC) against industrial action at Esso's Longford Plant in Victoria ...
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 Philippine section of The International Comparative Legal Guide to: Copyright 2016 was contributed by SyCipLaw partners Enrique T. Manuel and Vida M. Panganiban-Alindogan. Mr. Manuel heads the firm’s Intellectual Property department. The chapter includes information on copyright subsistence, ownership, exploitation, owners’ rights, copyright enforcement, criminal offenses, and current developments. 1 ...
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 ...
Lavery is closely monitoring developments in consumer class actions and, in order to keep the business sector informed on the subject, publishes regular newsletters on recent case law and legislative changes that are likely to affect, if not transform, business practices. INTRODUCTION In Fortin v. Mazda Canada Inc ...
The Philippine section of The International Comparative Legal Guide to: Trade Marks 2015 was contributed by SyCipLaw partners Enrique T. Manuel and Vida M. Panganiban-Alindogan. Mr. Manuel heads the firm’s Intellectual Property department ...
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”) ...
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 ...
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 ...
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”) ...
Following publication of the Regulation (EU) No. 2015/2424 which is part of the reform legislative package that also replaces the existing Trade Mark Directive, the long awaited reform of the existing Community trade mark will enter into force on 23 March 2016. The most evident change is that the Community trade mark will be renamed the European Union trade mark (EUTM), adopting the terminology of the Lisbon Treaty ...
Special Economic Zones (“SEZs”) are geographically designated areas within a country that are set aside for specifically targeted economic activities, supported through special arrangements (that may include laws) and systems to promote industrial development. An SEZ is meant to be an economic development tool to promote rapid economic growth by using various support measures to attract targeted foreign and domestic investments and technology ...
Last week, Greece's biggest tobacco company, "Seke", acquired four hectares of land in the industrial zone of Kruševo, Macedonia. It has been reported that the company's plan is to build a factory for tobacco processing there, and that the honorary investment in this case amounted to EUR 5 million. The main cause of interest in this area for Seke were the region's favourable conditions for tobacco growth, as well as the presence of good-quality, highly professional workers ...
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 ...
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 ...
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;
As the overall level of convergence between industries in the business world keeps increasing, it is only logical for the related legal aspects to follow suit every step of the way ...
In a unanimous decision rendered on May 16, 2016,1 the Québec Court of Appeal confirmed that the delivery of ophthalmic lenses purchased online from suppliers who are not members of the Ordre des optométristes (Order of Optometrists) (?Order?), or the Ordre des opticiens d?ordonnances (Order of Dispensing Opticians), does not violate the Optometry Act 2(?OA?) or, by necessary extension, the Dispensing Opticians Act ...
On May 10, 2016, the Québec Court of Appeal1 confirmed a Superior Court decision allowing an application for authorization of treatment and placement to a patient. The application had been brought by the Douglas Mental Health University Institute, commonly known as the Douglas, or the Douglas hospital ...
The recent First Chamber Supreme Court’s (SC) case law has been consistent when determining that the granting of clientele compensation in case of unilateral termination of the distribution agreement by the manufacturer could not be made automatically by analogous application of the Agency Contract Act, but by taking into account the particular casuistry ...
Last week, Governor Snyder wrote Michigan's congressional delegation to stress the importance of fully funding upgrades to the Soo Locks. Snyder urged Congress to replace the Davis and Sabin Locks with a single, larger lock that would provide redundancy should the Poe Lock fail. The Poe Lock is currently the only lock capable of handling the 1,000-foot freighters used to transport raw materials like iron ore ...
The Health Care Arbitral Tribunal (Arbitral Tribunal) has pronounced a decision on a dispute between an independent medical specialist and a Medical Specialist Company (MSC) for the first time since the introduction of the comprehensive rates on 1 January 2015. Although neither party has terminated the existing (membership) agreement between them, the Arbitral Tribunal is of the opinion that termination of membership and deregistration of the specialist from the members' register are justified ...
The Construction (Design and Management) Regulations (Northern Ireland) 2016 ("CDM 2016") come into force on 1 August 2016. The legislation includes transitional provisions, so that, where a project has already started by 1 August 2016, the Client must appoint a Principal Designer before 1 August 2017 (unless the project ends before that date). In the meantime, the existing CDM Co-ordinator must comply with the duties of a Principal Designer ...
