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Practice Industry: Government & Public Sector, Healthcare & Pharmaceuticals, Intellectual Property
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Makarim & Taira S. | June 2014

The Supreme Court of the Republic of Indonesia has issued Circular Letter No.2 of 2014 regarding Case Settlement in the Court of First Instance and Appeals in 4 (four) Justice Fields.  The Supreme Court considers that since an electronically based management case system now exists in the courts of first instance and high courts, cases should be examined and ruled on quickly ...

LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...

The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”).  On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...

Delphi | May 2014

Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs.  However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...

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 ...

Asters | April 2014

On March 28 2014 Law 642/2013 - a milestone of the government's anti-corporate raider policy - entered into force. Revival of the bill, which had previously gathered dust in parliamentary committees for several years, was a response to numerous calls from the international community to take measures to counter illegal takeovers and acquisitions of businesses ...

Lavery Lawyers | April 2014

On April 9 last, the Superior Court of Québec issued its judgement1 on a motion for a declaratory judgment pertaining to trademarks in the English language on public signs and posters. The applicants, Magasin Best Buy Ltée, Costco Wholesale Canada Ltd, Gap (Canada) Inc., Old Navy (Canada) Inc., Corporation Guess? Canada, la Compagnie Wal Mart du Canada, Toys “R” Us Canada Ltée and Curves International Inc ...

Following the Supreme Court’s decision in Bridge Trustees in 2011 (see further here), the Government announced that it would legislate to directly counteract the effect of the judgement and make it clear that benefits under a pension scheme cannot be regarded as money purchase benefits if it is possible for a funding deficit to arise in respect of any of those benefits ...

The new EU Procurement directive was published in the Official Journal of the EU today (28 March 2014) and will come into force on 17 April 2014.  This article summarises some of the key changes from the new Directive which are likely to be of interest to both the public and private sector. The UK will have 2 years to implement the Directive but the government has suggested that it will be implemented in a shorter timescale ...

Vouga Abogados | March 2014

The Executive Branch announced days ago the 3 main investment projects which will be promoted under the Public-Private Partnership regime in Paraguay. With the enactment in the month of March of the Regulatory Decree of the Public-Private Partnership Law (Law 5102/2013), the projects are expected to be advanced immediately ...

Veirano Advogados | March 2014

NEW CVM DECISION SIMPLIFIES TRANSACTIONS INVOLVING PRIVATE INVESTMENT IN PUBLIC EQUITY (PIPEs)  At a meeting held on January 7, 2014, the majority of the Brazilian Securities and Exchange Commission (“CVM”) Board (Colegiado) accepted the appeal lodged by João Fortes Engenharia S.A., within the context of CVM Proceeding No ...

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 ...

Delphi | March 2014

On 3 March 2014, the Government presented the bill ”Enhanced competition supervision” (Sw: “Förbättrad konkurrenstillsyn”) (Governmental Bill, prop. 2013/14:135) which contains several suggested changes to the Swedish Competition Act which relate, inter alia, to leniency and the possibility to suspend time limits during merger control assessments ...

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 ...

Garrigues | March 2014

As we indicated a few months ago, the partial reform of the intellectual property law continues its journey towards the Lower House of the Spanish Parliament. On Friday, February 14, the Cabinet approved the text of the preliminary bill, which must now get the green light from the consultative bodies and be debated in Parliament as a bill before its definitive approval. The main lines of the approved text are those we advanced in our previous post: 1 ...

Shepherd and Wedderburn LLP | February 2014

Following a period of consultation, the Government has confirmed that legislative changes will be made to ensure that “protected persons” will not be affected by the statutory amendment power being introduced as part of the abolition of defined benefit contracting-out ...

Hunton Andrews Kurth LLP | January 2014

Most marketers and retailers know that the consumer protection laws require that their advertising claims be substantiated, truthful and not misleading. But the new year is a good time to take stock of advertising campaigns, practices and procedures to make sure they pass muster under the Federal Trade Commission’s (FTC’s) latest guidance. The FTC’s recent enforcement actions provide a starting point ...

Hunton Andrews Kurth LLP | January 2014

On January 13, 2014, the Food and Drug Administration ("FDA" or "the Agency") announced the availability of a much-anticipated draft guidance on its intended regulation of product promotion conducted via social media, titled Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics ...

For more than twenty years, the federal government has attempted to limit the number of unsolicited phone calls consumers receive through the Telephone Consumer Protection Act, 47 U.S.C. § 227 (“TCPA”), which is perhaps best known for governing the famous “Do Not Call” list. Businesses, including banks and financial institutions, must understand the statute and stay abreast of its changes because the penalties for violating the TCPA are steep ...

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

More than three years after first announcing that it was considering issuing regulations applying the Americans with Disabilities Act to websites, the US Department of Justice (DOJ) appears on the verge of announcing its proposed rules for website accessibility. While the DOJ originally stated that it anticipated issuing its Title II website accessibility rules for websites operated by state and local governments by November 2013, it now expects to issue these rules by the end of the year ...

Shepherd and Wedderburn LLP | November 2013

In recognition of the increasing popularity in the market of asset-backed contribution arrangements (ABCs), the Pensions Regulator has issued detailed guidance for trustees considering using such a structure to fund their pension scheme. ABCs, in general terms, allow an employer operating a defined benefit pension scheme to use a non-cash asset to provide a regular income stream to the scheme without an outright disposal of the asset to the scheme ...

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 ...

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