The new Slovenian Public Procurement Act, the ZJN-3 ("Procurement Act"), enters into force on 1 April 2016. After a long period of dual regulation of the general and utility areas of public procurement, the new Procurement Act unifies both areas in a single act, thus invalidating the existing Public Procurement Act - ZJN-2, and the Act Regulating Public Procurement in Water, Energy, Transport and Postal Services - ZJNVETPS ...
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 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”) ...
The first set of commissioners to constitute the Philippine Competition Commission (PCC) has just been appointed. The PCC, a five member body created by the Philippine Competition Act (passed into law in July 21, 2015), is mandated to implement the national competition policy. Vested with a broad range of powers, it can conduct administrative inquiries, institute civil or criminal proceedings before the courts, and review proposed mergers and acquisitions ...
There has been a lot of talk recently about launching of the EU’s procedure for monitoring compliance with the rule of law in Poland, but not much about what exactly the procedure is. Observing the rule of law is a condition for joining and being a member of the European Union. Democracy, human rights and the rule of law are also enshrined in the preamble to the European Convention on Human Rights. Because the rule of law is one of the fundamental values of the EU defined in Art ...
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 ...
On February 12, 2016, the recently constituted Philippine Competition Commission (“PCC”), which was created under the Philippine Competition Act (Republic Act 10667 or the “PCA”), issued Memorandum Circular No ...
As part of the nuclear arrangement reached with Iran, the United States rescinded its nuclear-related sanctions imposed on entities outside the United States on January 16, 2016, which is the so-called “Implementation Day” under the Joint Comprehensive Plan of Action (“JCPOA”). At the same time, the United States also lifted sanctions on foreign subsidiaries of U.S. companies. Apart from a few specific exceptions, however, including new exceptions for U.S ...
What will happen if the objectives of the Paris Climate Agreement are not achieved? Most people assume that since the agreement is non-binding, failure to reach the targets will necessitate new political action, writes Lucas Bergkamp, Partner at the Brussels-based law firm Hunton & Williams LL.P. But according to Bergkamp, what is likely to happen is that climate activists will instead turn to the judiciary to enforce the treaty ...
On Tuesday, December 22, 2105, the US Court of Appeals for the Federal Circuit issued a much- anticipated opinion regarding the constitutionality of the prohibition against “disparaging” trademarks. In an 9-3 en banc opinion, the Federal Circuit held that the exclusion of disparaging trademarks under Section 2(a) of the Lanham Act violates the First Amendment.Many of the marks rejected as disparaging convey hurtful speech that harms members of stigmatized communities ...
The current Constitution of Ecuador was enacted in 2008. In the past seven years it had few changes. The last one was introduced by a resolution of the National Assembly (Congress), which was issued on December 21th 2015. This last amendments are: Reelection of popular election authorities (elected by voting).- The amendments allows to the current authorities to run as candidates to be re-elected indefinitely ...
Equity crowdfunding will soon have a new framework in which to operate in Canada and this is excellent news for investors and startups alike ...
Last April 27, the Court of Appeal of Quebec dismissed the appeal, from the bench, by the Attorney General of Quebec concerning the use of English trademarks on public signs ...
The Court of Justice has issued a judgment invalidating the European Commission’s Safe Harbour decision. This means that participation in the Safe Harbour programme by US entities is no longer grounds for European companies to transfer personal data of EEA citizens to the United States. On 6 October 2015, the Court of Justice of the European Union held that the European Commission’s decision approving the Safe Harbour programme is invalid (Schrems v Data Protection Commissioner, Case C-362/14) ...
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”) ...
Across Africa, investments in infrastructure have failed to keep pace with growth and demand, creating a tremendous infrastructure deficit. Less than 40pc of the population across the continent, and only 26pc of the population of sub-Saharan Africa, has access to electricity.Approximately, 34pc of the population has access to improved sanitation facilities, and 35pc lack access to clean drinking water ...
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 ...
The Philippines recently enacted Republic Act 10667 or the Philippine Competition Act which defines, prohibits and penalizes anti-competitive agreements, abuse of dominant position, and anti-competitive mergers and acquisitions. It also creates the Philippine Competition Commission, which has original and primary jurisdiction to deal with cases involving violations of the Act. The Act was published on July 24, 2015 and took effect on August 8, 2015 ...
This year’s amendment of the Waste Act is forcing changes in the scheduling of incinerator projects. Target load start-up tests must be postponed until after the integrated permit is issued. This may give rise to claims by contractors for prolonging the project completion period because of a change in the law. In Poland there are currently six communal waste incineration plants under construction with EU funding ...
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 ...
SyCip Salazar Hernandez & Gatmaitan contributed the Philippines chapter of Herbert Smith Freehills’ Guide to anti-corruption regulation in Asia Pacific 2015. The Guide provides a practical approach to applicable anti-bribery legislation and enforcement regimes. Contributed by managing partner Rafael A. Morales, partner Russel L. Rodriguez, and associate Vera Marie H ...
