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Practice Industry: Crossborder Trade & Investment, Healthcare & Pharmaceuticals, Life Sciences
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Lavery Lawyers | April 2014

On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...

MinterEllison | April 2014

With food and nutrition key issues for growing markets such as China, investment in Agribusiness is about supporting Asian partner objectives to grow "safe food" and "harvest protein", according to Adam Handley, President of the Australia China Business Council (WA) and a senior partner at law firm Minter Ellison ...

Makarim & Taira S. | April 2014

After 80 years using a very old Dutch trade law (Bedfrijfsreglementerings Ordonnantie 1934, Staatsblad 1938 Number 86), Indonesia has finally introduced its own Bill on Trade. The Bill on Trade was passed by the House of Representatives on 11 February 2014 and will come into effect on 13 March 2014 at the latest ...

Karanovic & Partners | March 2014

SerbiaIncreased  number of applications for industrial property protection It seems that the promotional efforts of the Intellectual Property Office of Serbia have been effective. According to statistics from the IP Office for 2013, the number of trademark applications increased by 40%, the number of patent applications increased by 5% and industrial design applications increased by 42% compared to last year ...

Beccar Varela | March 2014

As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...

ENS | March 2014

On 14 February 2014 the South African Department of Trade & Industry (DTI)  gave notice of its intention to prohibit the use of a large number of European food and drinks names in terms of  section 15 of the Merchandise Marks Act (MMA)  - confusingly the notice also makes reference to section 13 of the MMA, a section that no longer exists ...

Brigard Urrutia | March 2014

On February 28, 2014, the Colombian Government issued Decree 456 of 2014, whereby it established special tariffs applicable to the imports of clothing and shoes. The measure is a compound ad valorem (10%) and specific tariff (US$5) for imports of products classified under chapters 61, 62 and 62 of the Colombian Tariff Code, with prices under US$10 per kilogram, and to imports of products classified under chapter 64, with prices under US$7 per pair ...

MinterEllison | March 2014

In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...

A&L Goodbody LLP | March 2014

Horizon 2020 is the new EU Framework Programme offering more than €70bn funding for Research and Innovation initiatives over the period 2014 to 2020 and covering every stage of the innovation process from research to market uptake. Ivan Waide and Kate Keith, IP & Technology lawyers at A&L Goodbody, take a closer look at the programme, including opportunities available to Northern Ireland businesses and research organisations ...

Veirano Advogados | March 2014

The Central Bank of Brazil initiated a public hearing on 6 February to facilitate foreign investment. The Internet-delivered hearing will end on 7 April. The idea is to include under a single normative act the scattered provisions relating to fixed and variable income investment, as well as to portfolio investment.  The measure is one of initiatives taken by the Central Bank within its Otimiza-BC program of cost reduction ...

Shepherd and Wedderburn LLP | February 2014

In a decision that will please rights holders, the Court of Justice of the European Union (‘CJEU’) ruled last week that goods sold by a website based outside the EU are protected by EU intellectual property law if they are sold to a person in the EU. Mr Blomqvist lived in Denmark. He ordered a watch described as a Rolex from a Chinese website which was then sent to him from Hong Kong. The Danish customs authorities held the parcel on suspicion that it was a counterfeit ...

Karanovic & Partners | February 2014

Strategic Investment Act: The new Act on Strategic Investment in Croatia has achieved its goal of reducing administrative procedures and ensuring the speedy realisation of strategic projects in Croatia. In order to declare a project “strategic,” it must meet several criteria. Foremost, the project must be in accordance with spatial planning regulations. Also, the total amount of capital expense must be HRK 150 million (approx. EUR 19.6 million) or more ...

Hunton Andrews Kurth LLP | December 2013

As in past years, chemical, pharmaceutical and biotechnology patent cases in 2013 offered a combination of the predictable and the unpredictable. On the predictable end of the spectrum, the US Supreme Court offered no surprises ...

Haynes and Boone, LLP | December 2013

Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...

Hunton Andrews Kurth LLP | December 2013

Negotiation of the proposed EU Data Protection Regulation has faltered. While there is still a possibility that the Regulation could be passed before the May 2014 European elections, that looks increasingly remote. The main stumbling block appears to be the difficult issue of the ‘one stop shop’, which has produced deadlock within the Council of Ministers.  The ‘one stop shop’ proposal is inherently difficult, but until now has been referenced in somewhat superficial terms ...

Lavery Lawyers | November 2013

On Thursday, November 7, 2013, the United States Food and Drug Administration (FDA) announced measures to definitively eliminate all the artificial trans fats from processed products in the United States. The purpose of the proposal, which is released for public comments for a 60-day period, is to remove trans fats from the “generally recognized as safe” (“GRAS”) category, which would allow these products to be commonly used in food products ...

The Romanian Government has approved the necessary legislative amendments to create a holding regime in Romania, the ordinance being published in the Official Gazette on Friday, November 15, effective as of January 1st, 2014.   The ordinance includes profits tax exemptions for Romanian holding companies as regards revenues from dividends received, revenues from the sale of shares and revenues from the liquidation process ...

Dykema | November 2013

On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...

BUSTAMANTE FABARA | November 2013

In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...

Wardynski & Partners | October 2013

In the innovativeness of its economy, Poland ranks 4th from last in the European Union, but greater support is planned for highly innovative projects that show promise for implementation and commercialisation in Poland. At a session of the Polish Parliament’s Innovation and New Technology Committee on 19 June 2013, the Ministry of Regional Development presented the guidelines for operational programmes Smart Growth 2014–2020 and IT & Telecommunications 2014–2020 ...

Misick and Stanbrook | October 2013

The Turks and Caicos Islands (TCI) has just enacted a revamped investor residency programme, entitling successful applicants to a permanent residence certificate (PRC). The Qualifying criteria are: Villas a. Investment of not less than $300,000 in actual construction of a new home, or in renovation of a distressed property as a home for the applicant and his or her dependants, on the islands of Grand Turk, Salt Cay, South Caicos, Middle Caicos or North Caicos; or b ...

Plesner | August 2013

Denmark has a large life science sector, including a number of biotech and pharmaceutical companies and research activities. The sector is highly regulated and covered by extensive and complicated statutory requirements, executive orders and ethical standards. Denmark has incorporated most of the EU regulation and Danish law is thus to a large extent in conformity with the general EU regulation and practice of, for example, the European Medicines Agency (‘EMA’) ...

Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”).  After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...

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