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.
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.
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".
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.
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.
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.
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.
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.
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.
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.
The Federal Court of Canada has refused Pfizer's motion to dismiss an action under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations between Amgen and Pfizer. Pfizer sought to dismiss the action, asserting that it was redundant, scandalous, frivolous, vexatious or otherwise an abuse of process. Pfizer based its argument on a decision under the old PMNOC Regulations in which the court had found that Apotex's allegation of invalidity was justified.
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.
The minister of health recently made an order permitting the immediate import and sale of epinephrine auto-injectors for use in emergency treatment of life-threatening allergic reactions to address the shortage of EpiPen products. This is the first time that an interim order under Section 30.1(2)(a) of the Food and Drugs Act has been used to address the shortage of an approved product.
The Federal Court recently dismissed Valeant's application under the Patented Medicines (Notice of Compliance) Regulations regarding Ranbaxy's bupropion extended-release tablets. The court found that the amount of permeation enhancer in the Ranbaxy formulation was outside the scope of the range claimed. As such, Ranbaxy's allegation of non-infringement was found to be justified.
The Supreme Court of Canada recently denied Sobeys' application for leave to appeal the Alberta Court of Appeal's decision in a dispute regarding the Alberta College of Pharmacists' policy prohibiting pharmacists and pharmacies from offering loyalty rewards programmes or inducements to patients. This decision follows the court's 2016 refusal to grant Sobeys leave to appeal a decision allowing the College of Pharmacists of British Columbia to prohibit "customer incentive programmes".
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.
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.
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.
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.
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.
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.
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.