Healthcare & Life Sciences updates

Austria

Contributed by Preslmayr Attorneys at Law
Misleading comparative advertising of drugs
  • Austria
  • 28 November 2018

The Supreme Court recently ruled in an interesting case relating to comparative advertising. The court ultimately found that the challenged announcement was 'comparative advertising' within the meaning set out in Section 2a(1) of the Unfair Competition Act, as it directly and indirectly identified a competitor and its goods and services. The decision follows the letter of the law and perfectly summarises the legal structure regarding comparative and drug advertising in Austria.

No liability for in-depth specialist knowledge
  • Austria
  • 07 November 2018

The Supreme Court recently provided an extensive description of the principles of medical liability and held, in concrete terms, that the standard of care principle must not be overstretched. The court confirmed that the expert liability provided for in the General Civil Code is based on an objective standard and thus depends on the usual diligence of the persons who carry out the activity in question. As such, the performance standard of the occupational group concerned will be a decisive factor.

Detox capsules
  • Austria
  • 05 September 2018

The Supreme Court recently ruled on the advertising of a product which sits in the grey zone between medicinal products, medical devices and foodstuffs. Among other things, the plaintiffs had originally requested that the defendant be prohibited from offering and distributing products containing zeolite and bentonite as medical devices if they were not authorised as such, including disease-related information in the advertising of those products and promoting the products as "vegan, lactose-free and gluten-free".

Spiritual healing – no (illegal) quackery
  • Austria
  • 27 June 2018

The delineation between medical treatment and quackery is not always easy to draw. A recent Supreme Administrative Court decision has brought some clarifications as to what constitutes legitimate medical treatment as opposed to illegal quackery.

Fat-burning injections – medical information from beauticians
  • Austria
  • 25 April 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.


Brazil

Health sector transparency laws
  • Brazil
  • 05 September 2018

Since 2016 Minas Gerais has been establishing transparency laws to create a system whereby consumers and society at large will be able to access information regarding incentives and payments between healthcare professionals and the health industry. Under the state laws, the health industry must provide information on the relationships that they maintain with healthcare professionals which may represent a potential conflict of interest.

Post-trial access: Congress discusses new bill for clinical research
  • Brazil
  • 23 May 2018

The importance of clinical research for developing new treatments and discovering cures for diseases is indisputable. However, the degree to which patients benefit from participating in clinical trials and whether they should have post-trial access to experimental treatments are highly disputed, especially in Brazil, where free universal healthcare is a constitutional right. The House of Representatives is discussing clinical research and post-trial access as part of a new legislative bill.

Vaccines and points of care – growing trend
  • Brazil
  • 28 March 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
  • 08 November 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
  • 06 September 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.


Canada

Contributed by Smart & Biggar/Fetherstonhaugh
List of generic submissions under review now available
  • Canada
  • 16 January 2019

Health Canada recently advised that it would implement certain proposals for its prescription drug product transparency initiatives. In particular, Health Canada will start providing regulatory decision summaries for the approval of drugs which are approved on the basis of abbreviated new drug submissions. Among others things, Health Canada now provides a new, separate Generic Submissions Under Review List, which includes a list of the generic submissions under review by medicinal ingredient.

Federal Court of Appeal overturns cefaclor damages decision on pre-judgment interest issue
  • Canada
  • 16 January 2019

The Federal Court of Appeal recently allowed in part Apotex's appeal of a decision awarding Eli Lilly over C$100 million for Apotex's infringement of eight process patents relating to the antibiotic cefaclor. The court remitted the decision to the Federal Court for reconsideration solely on the issue of interest.

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
  • Canada
  • 19 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
  • Canada
  • 19 December 2018

A Federal Court order has issued on a motion to strike that was brought by Sandoz in four actions relating to the infringement of rituximab patents. The court declined to strike out the claims for damages and an accounting of profits on the basis that, at law, such remedies are unavailable in such an action. The court's treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the Patented Medicines (Notice of Compliance) Regulations.

Apotex not permitted to plead promise-based invalidity grounds in Section 8 lansoprazole action
  • Canada
  • 21 November 2018

The Ontario Superior Court of Justice recently dismissed Apotex's motion to plead promise-based invalidity grounds in a Section 8 lansoprazole action. The motion had arisen in the context of a Section 8 action in which Apotex claimed damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's Prevacid) due to prohibition applications commenced by Abbott and Takeda.


China

Regulation on the Supervision and Administration of Medical Devices amended
  • China
  • 28 June 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
  • 31 May 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
  • 22 March 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
  • 08 March 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.


Denmark

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