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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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DFDL | May 2016

INDUSTRIAL RELATIONSPROMULGATION OF THE LAW ON TRADE UNIONS, Royal Kram № NS/RKM/1516/007, dated 17 May 2016The Law on Trade Unions is intended to: (a) provide rights and freedom for enterprises, establishments and persons governed by the provisions of the 1997 Labour Law and persons serving in air and maritime transportation and (b) sets out the organization and functioning of professional organizations of employees and employers ...

ENSafrica | May 2016

The Lagos Tax Appeal Tribunal (“TAT”) on 12 February 2016 ruled in favour of the Federal Inland Revenue Service (“FIRS”) in its case with Vodacom Business Nigeria Limited (“Vodacom”) that satellite-network bandwidth capacities provided to Vodacom outside Nigeria by New Skies Satellites (“NSS”), a Dutch incorporated company, are liable to value added tax (“VAT”) in Nigeria ...

Waller | May 2016

The U.S. International Trade Commission (“ITC”) recently issued a Final Determination concluding that certain dental implants imported by Instradent USA, Inc. and by JJGC Industria e Comercio de Materiais Dentarios S/A of Brazil (“Respondents”) infringe U.S. Patent Numbers 8,714,977 and 8,764,443 and should be blocked from entry into the United States ...

Asters | May 2016

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;

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ENSafrica | May 2016

BOTSWANA: Protocol to treaty between Botswana and Sweden enters into force The amending protocol to the Botswana/Sweden Income Tax Treaty (1992), which was signed on 20 February 2013, entered into force on 1 December 2015. The protocol generally applies from 1 December 2015 for the provisions on exchange of information and from 1 January 2016 for the remaining provisions ...

ENSafrica | May 2016

At the opening ceremony of the Forum on China-Africa Cooperation (“FOCAC”) summit held in Johannesburg in December 2015, the President of the People’s Republic of China, Xi Jinping, announced that China intends to invest US$60-billion in Africa over the next three years. This undoubtedly reaffirms the commitment by China and Africa to bilateral cooperation, thereby furthering China’s “One Belt, One Road” foreign policy ...

Van Doorne | May 2016

The European Commission has presented an Action Plan setting out ways to reboot the current EU VAT system to make it simpler, more fraud-proof and business-friendly. The current VAT rules urgently need to be updated so they can better support the Single Market, facilitate cross-border trade and keep pace with today's digital and mobile economy ...

ALRUD Law Firm | April 2016

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 ...

Haynes and Boone, LLP | April 2016

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 ...

Waller | April 2016

Last month, CMS issued a proposed rule that would drastically expand the agency’s authority to further its program integrity efforts through the provider and supplier enrollment process. This proposed rule, referred to as CMS-6058-P, (located in the Federal Register at 81 Fed. Reg. 40 ...

Waller | April 2016

A number of events have occurred recently involving the Federal Trade Commission and healthcare entities. First, garnering the lead spotlight, the FTC began presenting its case in the U.S. District Court for Northern Illinois to enjoin a merger between Advocate Health and NorthShore University HealthSystem, two large Chicago-area health systems ...

Waller | April 2016

As the delivery of health care continues to evolve and hospitals bear additional pressures to adapt to new payment models, more nonprofit hospitals are partnering with for-profit providers, through a sale, joint venture, or other arrangements. Partnerships between independent nonprofit hospitals and larger health care systems (nonprofit and for-profit) have been growing over the past two decades ...

Waller | April 2016

On March 30, the Department of Justice (DOJ) announced a major new initiative to target quality of care and fraud and abuse in elder care by forming 10 Elder Justice Task Forces throughout the United States. The DOJ intends to build these task forces on interdisciplinary teams – including Health Care Fraud Enforcement Action or HEAT Teams – already at work in several districts across the country. The teams include representatives from the U.S ...

Jeantet | April 2016

2015 was a record year in the Hungarian M&A market. Both in terms of value and number of transactions, 2015 was the best year since 2008, with approximately 160 closed transactions and an aggregate value of approximately EUR 2 billion. Although the acceleration follows global trends, the Hungarian market has a few specifics that will further enhance a growing M&A market in 2016 as well ...

Shearn Delamore & Co. | April 2016

It won’t be long before Malaysia becomes a party to the Madrid Protocol with strong indicationspointing towards Malaysia acceding to this treaty by 2013. The Madrid Protocol system, which is a global trademark registration system is administered centrally by the International Bureau of the WorldIntellectual Property Organisation (WIPO), located in Geneva, Switzerland ...

ENSafrica | March 2016

Important notification of four new guidelines for the compilation of mandatory codes of practice, which are binding in terms of the Mine Health and Safety Act 29 of 1996 (“the MHSA”).Kindly take note that on Friday, 5 February 2016, notices were published in Government Gazette No ...

ENSafrica | March 2016

ANGOLA: Budget Law 2016 published Law No. 28/15 (“Budget Law 2016”), which had been adopted on 31 December 2015, was published on 30 January 2016 and applies with effect from 1 January 2016. The Budget Law 2016 provides for: · the introduction of a Special Contribution on Banking Operations, to be levied at the rate of 0.1% on all financial operations by banking and non-banking financial institutions governed by the Financial Institutions Framework Law (Law 12/15 of 27 June 2015) ...

Haynes and Boone, LLP | March 2016

The FDA’s Proposals on the Revision of the Nutrition and Supplement Facts Labels In early 2014, first lady Michelle Obama announced upcoming changes to the FDA’s Nutrition Facts label, and in March 2014, the FDA issued a proposed rule on the revision of Nutrition and Supplement Facts labels “to assist consumers in maintaining healthy dietary practices ...

Carey | March 2016

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”) ...

MinterEllison | March 2016

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 ...

A&L Goodbody LLP | March 2016

Are you ready to disclose? All Transfers of Value (ToV) from 2015 must be disclosed publicly via the Irish Pharmaceutical Healthcare Association (IPHA) central reporting system by 1 July 2016. This relates to all ToVs that were made by pharmaceutical companies to Healthcare Providers (HCPs) and Healthcare Organisations (HCOs) in connection with the development and sale of prescription only medicinal products for human use ...

Shoosmiths LLP | March 2016

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 ...

Haynes and Boone, LLP | February 2016

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”) ...

Haynes and Boone, LLP | February 2016

The United States has announced that it has signed with Cuba a new agreement covering air services between the two countries.  The new agreement, which replaces a suspended accord dating back to the 1950s, authorizes up to 110 daily round trip scheduled flights between the two countries by airlines of each respective country. The agreement permits twenty (20) scheduled non-stop flights between the U.S ...

Haynes and Boone, LLP | February 2016

On January 27, 2016, the Obama Administration took the latest in its continuing steps to ease restrictions on trade and travel between the United States and Cuba. Amendments to the Cuban Assets Control Regulations (“CACR”) administered by the Treasury Department’s Office of Foreign Assets Control (“OFAC”) and the Commerce Department’s Bureau of Industry and Security (“BIS”) will authorize additional U.S ...