Healthcare & Life Sciences updates

Austria

Contributed by Preslmayr Attorneys at Law
Fat-burning injections – medical information from beauticians
  • Austria
  • April 25 2018

A client recently sued her beautician because of an unsuccessful fat-burning injection treatment. The first-instance court granted the plaintiff two-thirds of her claim, holding that the defendant had had the same obligation as a physician to provide medical information on the risks and complications. However, as the plaintiff had been aware of the defendant's inexperience, she was responsible for the contributory fault, which reduced her claim by one-third.

Medical confidentiality and right to refuse to give evidence
  • Austria
  • February 28 2018

In general, a healthcare professional may testify on observations made in respect of a patient only if he or she has been released from the obligation of confidentiality by the patient personally. However, there are a few limited exceptions to this general rule. The Supreme Court carefully applied these exemptions in a recent decision on the hypothetical release by a deceased person.

Medical information and informed consent
  • Austria
  • January 03 2018

Providing patients with insufficient medical information may impede their ability to give informed consent to proposed medical treatments and thus may trigger the tort liability of physicians or healthcare institutions. However, a March 2017 Supreme Court decision has reduced the scope of the medical information that must be provided to patients.

Assessing demand for public pharmacies – a never-ending story
  • Austria
  • October 04 2017

Public pharmacies are heavily regulated in Austria. The opening of new (or the relocation of existing) pharmacies is subject to approval by the district authority. Approval will be granted only if there exists a viable need for the new public pharmacy. In a recent case, two courts ignored a 2016 amendment to Section 10 of the Pharmacies Act, which allowed a deviation from the strict 5,500 person limit set out therein.

New price cap for medicinal products
  • Austria
  • July 19 2017

After 14 months of negotiations between the Federation of Austrian Social Security Institutions and the pharmaceutical industry, and lengthy discussions within the government coalition, Parliament recently adopted a new price cap for expensive medicinal products and a new price regime for generics and biosimilars. The government, social security institutions and the legislature hope that these amendments will create further savings in relation to expenses for medicinal products.


Brazil

Contributed by TozziniFreire Advogados
Vaccines and points of care – growing trend
  • Brazil
  • March 28 2018

One of the most influential moves in the healthcare sector is the recent development of point-of-care solutions. The main goal is to allow patients to get on-demand healthcare outside the hospital, mainly through medical devices and apps. Such technologies are likely to have a significant positive effect in the Brazilian public health system by making diagnostic testing accessible in areas where healthcare is hard to access.

Creating healthcare solutions with blockchain technology
  • Brazil
  • November 08 2017

The continuity of traditional healthcare models seems unlikely with the breakthrough of disruptive technologies. Historically, the healthcare sector has been slow to implement technological tools that have quickly transformed other areas of people's daily lives. However, a promising solution to address the interoperability, integrity and security challenges presented in the healthcare sector seems to be blockchain technology.

Telemedicine and its effects on healthcare
  • Brazil
  • September 06 2017

Advances in technology and the so-called 'fourth industrial revolution' continue to have an effect on society. For instance, telemedicine has rapidly developed and transformed the services provided by healthcare providers worldwide. Due to the expansion of telemedicine in Brazil, the Federal Council of Medicine intends to review and update Resolution 1643, which will hopefully attract new players to the market.

Tax aspects of healthcare products
  • Brazil
  • July 26 2017

Brazil's complex and inefficient tax system is known worldwide. In addition to a heavy tax burden, the tax compliance costs that companies must bear in order to do business in the country are particularly high. This is also the case for the healthcare sector. However, there are specific cases of tax exemption, 0% tax rates and other exceptions which aim to reduce the final price of pharmaceutical products, devices and equipment. Several of these rules add to the complexity of Brazil's puzzling tax system.

HIV self-testing kit now available
  • Brazil
  • June 28 2017

Brazilian citizens will soon be able to test themselves for the HIV virus in their blood. The National Health Surveillance Agency recently approved the registration of the first HIV self-testing kit in the country, following the issuance of Resolution 52/2015. Brazil has joined other countries which have already approved the registration of an HIV self-testing kit to help to fight against undiagnosed people living with HIV.


Canada

Contributed by Smart & Biggar/Fetherstonhaugh
No Section 8 liability for valid and infringed patent in Nexium proceeding
  • Canada
  • April 18 2018

If a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) Regulations against a generic entrant, but subsequently prevails in an infringement action regarding the same patent, can it be liable for Section 8 damages under the regulations? According to a recent Federal Court decision, the answer appears to be no.

Court dismisses Section 8 damages appeal and grants cross-appeal
  • Canada
  • April 18 2018

The Federal Court of Appeal recently issued public reasons for its dismissal of Eli Lilly Canada Inc's appeal of a Federal Court decision that had awarded Teva Canada Limited more than C$70 million under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. The court granted Teva's cross-appeal – which sought to add to its recovery of lost pipefill sales – and an adjustment to account for an underreporting of sales in the data relied on by both parties' experts.

Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
  • Canada
  • April 11 2018

In 2016 the Federal Court found that Apotex and Cobalt had infringed Bayer's valid patent for an oral contraceptive composition. The Federal Court subsequently held that Bayer was entitled to elect between damages and an accounting of Apotex's profits. In so holding, the court disagreed with Apotex's argument that it, rather than Bayer, should be entitled to elect whether Bayer should be limited to recovering Apotex's profits. The Federal Court of Appeal recently dismissed Apotex's appeal of the latter decision.

CADTH outlines revisions to biosimilar and pharmaceutical review programmes
  • Canada
  • April 04 2018

In its Common Drug Review Update – Issue 133, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process. Among other things, the update created a streamlined approach for biosimilar reviews, made application fees applicable to all Common Drug Review submissions and resubmissions and introduced new fee guidance for pharmaceutical review programmes.

Court denies pleading amendments regarding Supreme Court decision that struck down promise doctrine
  • Canada
  • April 04 2018

After the Federal Court found certain claims of a Canadian patent to be invalid, Apotex sought relief in the Ontario Superior Court of Justice pursuant to the Ontario Statute of Monopolies, the UK Statute of Monopolies and the Trademarks Act. The latter court recently dismissed motions by the defendants for leave to amend their statements of defence following the recent Supreme Court decision in AstraZeneca Canada Inc v Apotex Inc, which struck down the promise doctrine.


China

Regulation on the Supervision and Administration of Medical Devices amended
  • China
  • June 28 2017

The State Council recently promulgated amendments to the Regulation on the Supervision and Administration of Medical Devices 2014, which took effect immediately. The amendments clarify issues relating to device distributors' liabilities when selling non-conforming products, the use of large medical equipment and the revocation of clinical study site certification.

CFDA calls for comments on key policy proposals
  • China
  • May 31 2017

The China Food and Drug Administration recently issued four new draft policies for public comment, proposing further reforms to the existing drug and medical device regulatory regime. The draft policies aim to expedite the review and approval of new drug and medical device applications, deregulate the conduct of clinical trials to encourage innovation, enhance post-market supervision throughout a product's lifecycle and protect innovators' rights.

CFDA amends medical device recall rules
  • China
  • March 22 2017

The China Food and Drug Administration recently issued the Provisions for Medical Device Recall. While the new recall rules follow the basic regulatory framework for recalling devices provided in the existing rules, they also introduce some significant changes. The new rules clarify the scope of their application and the entity responsible for recalls, expand the definition of a 'defective product' and increase the penalties for manufacturers that refuse to implement mandatory recalls.

State Council announces policies to reform pharmaceutical industry
  • China
  • March 08 2017

China's pharmaceutical industry is set to undergo further change as part of the healthcare reform initiatives recently announced by the State Council in its Circular on Several Opinions Concerning Further Reforms of the Policies Governing Drug Production, Circulation and Usage. The circular reinforces the government's determination to expedite the approval process for new drugs and calls for quality consistency tests for generics.

CFDA solicits comments on pharmaceutical GCPs
  • China
  • January 18 2017

The China Food and Drug Administration recently proposed the most comprehensive revisions of the pharmaceutical good clinical practices (GCPs) in 13 years. The revisions have rewritten the articles of the existing pharmaceutical GCPs and provide general principles for conducting clinical studies in China; guidance on the roles and responsibilities of ethics committees, investigators and sponsors; and requirements for protocol and investigator brochures.


Denmark

Court awards historically high damages in patent case
  • Denmark
  • February 08 2017

The Maritime and Commercial High Court recently awarded Teva Denmark A/S €13.45 million in damages and €594,000 in legal costs in a patent case. This is the largest amount of damages ever awarded in a Danish patent case and will therefore be subject to thorough review when constructing arguments on damages in future cases.

Repackaging parallel imported pharmaceuticals – new interpretation of necessity requirement
  • Denmark
  • December 14 2016

The Maritime and Commercial High Court recently referred to the European Court of Justice the question of whether a trademark holder can lawfully object to the continued marketing of a parallel imported, repackaged pharmaceutical product on which its trademark has been reaffixed if the trademark holder has marketed the product in the same volume and packet size in other European Economic Area countries.

Quetiapine patent invalidated – Danish court follows suit
  • Denmark
  • September 07 2016

The Maritime and Commercial High Court recently invalidated AstraZeneca's Danish quetiapine sustained release patent in litigation against Teva Denmark A/S and Accord Healthcare Ltd. Before this judgment, the validity of AstraZeneca's patent had been successfully challenged in several European countries, including the United Kingdom, Spain, Germany and the Netherlands.

Specific Mechanism applies to paediatric extension of SPCs and all strengths of pharmaceutical
  • Denmark
  • June 08 2016

The Supreme Court recently examined a case regarding whether the Specific Mechanism applies to the extension of a supplementary protection certificate (SPC) under the Paediatric Extension Regulation. The court confirmed the enforceability of the Specific Mechanism against the parallel import of pharmaceuticals from new EU member states, even if the extended SPC is based on the Paediatric Extension Regulation.