Since at the end of this month, specifically on 30 June 2016, the first interim rights to operate remote gambling, granted by NGO, will expire, we expect to see the first licenses (Class I) and the authorizations to operate and exploit remote gambling in Romania entering into force on 1st of July 2016 ...
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 ...
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 ...
Judging by industry reports, it seems that another rich tourist season is in the making for Slovenia. The spas are working at full capacity during Easter and May holidays, and both international and domestic guests are pouring in ...
The Copy Right Act 1987 provides a framework for the protection of copy right and enforcement through civil redress, as well as outlines the powers granted to state authorities for the enforcement of copy right and prosecution of copy right offences. The Copy Right Amendment Act 2012 (“2012 Amendment Act”) came into operation on 1st March 2012. The following is a summary of some of the amendmentspursuant to the 2012 Amendment Act ...
As we know, colour usually attracts special attention of the consumers when choosing particular goods and/or services. The situation is similar with the consumers all over the world. Thus, it seems more than logical that companies will try to obtain exclusive rights to the specific colour to increase sales. Legislations in many countries provide for possibility of protection colour as a Trademark. However, a single colour Trademark registration is still exceptional ...
A South African university has successfully objected to a domain name that incorporates the university’s nickname.North-West University (“NWU”), once an exclusively Afrikaans-language institution that’s situated in the city of Potchefstroom, and that was formerly known as the Potchefstroom University College – or PUK – for short (the Afrikaans word for “college” starts with “k”), opposed a registration for the domain name propuk.co.za ...
There’s seemingly no end to the question of whether or not Nestlé can register the four-finger shape of its Kit Kat chocolate bar as a trade mark.Except, of course, in South Africa, where we know that it can. We know that because the South African Supreme Court of Appeal came to that conclusion in 2014 ...
On 25 January 2016, Botswana’s Companies and Intellectual Property Authority (“the CIPA”) issued a notice informing the public that it is not currently able to conduct hearings for trade mark oppositions and invalidations as a result of the recent restructuring of the Botswana Intellectual Property Office. The restructure led to the loss of staff responsible for the processing of opposition hearings and invalidations ...
There is nothing surprising about the leisure industry in Croatia giving off its first sparks of activity around this time of the year, especially considering the country's popularity in the nearing summer season and the ever-growing number of tourists, yearly pouring onto its seaside from every part of Europe and elsewhere ...
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 ...
As in most countries, Brazil has strict regulations on sensitive advertising, especially as regards to alcohol, tobacco and other controlled substances. In Brazil, advertising is regulated by the Federal Constitution, which main directive is the freedom of speech. However, the Constitution also predicts that regulations referring to products that offer health and environmental risks will be provided by specific laws (section 220) and follow some restrictions ...
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 ...
INTRODUCTION With the increased, Europe-wide focus on countering money laundering and terrorist financing in recent years, it is an anomaly that Irish anti-money laundering and anti-terrorist financing laws have not to date been extended to cover land-based or online bookmakers or gaming operators ...
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”) ...
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 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 ...
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 ...
