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Practice Industry: Dispute Resolution, Government & Public Sector, Healthcare & Pharmaceuticals
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ALRUD Law Firm | May 2016

Dear All, ALRUD Law Firm hereby informs that the amendments introduced to Arbitrazh procedural code in accordance with Federal law as of 02 March 2016 No. 47-FZ “On the amendments to APK RF” (hereinafter referred to as – “Law”) will come into effect on 01 July 2016. The Law remains in line with the general trend on reduction of arbitrazh (state commercial) courts workload and speeding up arbitrazh proceedings ...

Plesner | May 2016

By a judgment of 24 May 2016 in the MT Højgaard/Züblin case (Case C-369/14), the Court of Justice of the European Union has pronounced on the possibilities of changing the identity or the composition of a preselected entity during an award procedure. The case was a result of E ...

The Defend Trade Secrets Act of 2016 (DTSA) - arguably the most significant change to U.S. intellectual property laws in the past decade - was signed into law by President Obama on May 11, 2016. The DTSA creates a federal, civil remedy for misappropriation of a trade secret that is related to a product or service used in, or intended for use in, interstate or foreign commerce ...

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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Slovenia has amended the Financial Operations, Insolvency Proceedings and Compulsory Dissolution Act (ZFPPIPP or the Insolvency Act) again, following amendments in 2013, amending preventive restructuring, simplified compulsory settlement and personal bankruptcy proceedings. Amendments to the Insolvency Act, which were adopted by the National Assembly on 31 March 2016, will come into force on 26 April 2016 ...

Poland did not manage to implement the EU’s new procurement directives on schedule, but contracting authorities are required to conduct proceedings in full compliance with EU law. “In Principle”: The deadline for implementation of the new procurement directives into national law passed in April, but the old act is still in force in Poland ...

Karanovic & Partners | April 2016

​Another piece of news related to our competition team in Serbia are the recent signings of a Memorandum of Understanding and Agreement of Cooperation in the field of forensics between the Commission for the Protection of Competition and the Ministry of Internal Affairs (MIA) ...

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 ...

Karanovic & Partners | March 2016

 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 ...

Karanovic & Partners | March 2016

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 ...

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 ...

Shoosmiths LLP | March 2016

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 ...

Shoosmiths LLP | March 2016

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 ...

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”) ...

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 ...

Wardynski & Partners | February 2016

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 ...

Lavery Lawyers | February 2016

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 ...

Haynes and Boone, LLP | January 2016

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 ...

Hunton Andrews Kurth LLP | January 2016

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 ...

Hunton Andrews Kurth LLP | December 2015

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 ...

ALTIUS/Tiberghien | December 2015

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 ...