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 ...
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 ...
Businesses face an increasing number of challenges and one of the most severe and potentially damaging is that of cybercrime. Fallout from a cyber-attack can result in both physical as well as reputational damage and the loss of business and customers. Chilling words - particularly given how much British businesses now rely on their online presence ...
With increasing numbers campaigning for Britain to leave the EU, ever closer union is looking ever more uncertain. Opinion about the positive and negative aspects of Britain remaining within the EU is diverse. Whatever decision is made, companies need to be prepared for the potential outcomes. This article looks at the likely impact of the referendum (whatever its outcome) and provides some positive steps for companies to take ...
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 ...
On 23 January 2015, the Supreme Court delivered a judgment concerning the moderation of an invalid non-competition clause in a business transfer agreement. This judgment arose after the Ghent Court of Appeal had refused to moderate a non-competition obligation lasting for period of 17 years. In line with previous case law, the clause was declared absolutely null and void and the Ghent Court of Appeal ruled that the clause could not be mitigated in any way ...
Cuba’s stated goal of attracting billions of dollars in foreign investment combined with the United States’ effort to re-establish diplomatic ties with Cuba have sparked intensified interest amongst potential investors seeking to enter the Cuban market.As with any emerging market, potential investors must balance the potential risks faced in doing business with the potential return on their investment ...
The Trans-Pacific Partnership, or TPP is a free-trade agreement among the members: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam and the United States.On Nov. 5, the full text of the TPP trade agreement was released to the public for the first time. While, as reported, an agreement on the TPP was reached Oct. 5, each of the members must still enact it.An important component is the chapter on investments, which protects investors ...
The Trans-Pacific Partnership (“TPP”) is a free-trade agreement among Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, Vietnam and the United States (the “TPP Members”). While, as reported, an agreement on the TPP was reached on October 5, 2015, each of the TPP Members must still enact the TPP. On November 5, 2015, the full text of the TPP trade agreement was released to the public for the first time ...
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 ...
Argentina has thwarted debt security holders’ attempts to collect on their bond default judgments stemming from the nation’s 2001 economic collapse and subsequent repayment moratorium.EM Ltd. and NML Capital, Ltd ...
The federal securities laws require public companies to make and keep detailed and accurate “books, records, and accounts.” One might assume that a securities law relating to books and records covers materials used in the preparation of financial statements. But in practice, the U.S. Securities and Exchange Commission applies a much broader definition that seems to encompass every piece of paper and data in a company’s possession ...
When not conducted carefully, internal investigations cancause more harm than good. Deciding to investigate a suspected problem is onlythe first of several key determinations. The responsible executive must planand execute the investigation deliberately to avoid self-inflicted harm. Anorganization can protect itself—while still conducting an investigation that isconfidential, full and fair—only by carefully thinking about how best touncover the alleged wrongdoing or compliance issues ...
The New England Patriots may play the first quarter of the 2015-16 season without quarterback Tom Brady, as he was suspended for failing to cooperate with an investigation related to footballs deflated below league standards being used in the 2014-15 season AFC championship game with the Indianapolis Colts ...
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 ...
When one thinks of resolving disputes in Serbia, the first thing that comes to mind is the long, costly, inefficient dispute before a court, in a dusty court-room in a socialist architecture grey building. Even though these conditions still are reality, Serbia is making efforts in recent years to achieve higher efficiency in resolving disputes through various types of judicial reform including arbitration as one of dispute resolution mechanisms ...
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 ...
Following Cuba’s removal from the list of State Sponsors of Terrorism on May 29, 2015, the United States and Cuba took an additional step towards normalizing relations by announcing the reopening of embassies after more than five decades of their closure. The announcement of an agreement to reopen embassies, which was made today, is the first step in converting each country’s present “Interests Section” into formal embassies ...
