While there are signs of greater liberalisation with respect to hemp use internationally, the Austrian government has resisted this trend. In October 2018 the Ministry of Labour, Social Affairs, Health and Consumer Protection published a decree outlining its legal opinion on product regulations which prohibit CBD use in food and cosmetics. However, rather than providing legal certainty, the decree merely reflects headlines relating to the government's narcotics programme.
The Austrian social security system has been characterised by regional and occupational fragmentation and the domination of employee representatives. However, a recent amendment to the Social Security Act proposes merging the provincial social security institutions with the company insurers into one Austrian Health Insurer, which will be the only provider of employee health insurance.
The two chambers of the Austrian Parliament recently adopted the government bill on the amendment of the Act on the Medical Profession. The amendment will enter into force following its publication in the Law Gazette, which is expected in late January 2019.
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.
A legislative package aimed at fighting falsified medicines will enter into force in the European Union in early 2019. This EU legal framework was transposed into Belgian law through the Medicines Act and the Royal Decree concerning Medicines for Human and Veterinary Use. As a result, pharmaceutical companies will be required to affix a so-called 'anti-tampering device' on all prescription medicinal products to allow verification of whether the packaging has been tampered with.
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 Appeal recently affirmed the Federal Court's dismissal of Apotex's application for judicial review of a minister of health decision relating to its Apo-Omeprazole (omeprazole magnesium) delayed-release tablets. The minister had issued a Notice of Non-Compliance – Withdrawal letter in respect of Apotex's abbreviated new drug submission on the basis that the tablets were not bioequivalent to the relevant Canadian reference product.
The Federal Court recently dismissed Servier's application for a prohibition order under the pre-amended Patented Medicines (Notice of Compliance) Regulations for Canadian Patent 2,423,825 regarding a perindopril arginine/amlodipine product (Servier's Viacoram). Apotex had alleged that the patent was invalid for obviousness, overbreadth, inutility and insufficiency.
The Ontario Court of Appeal has overturned the Ontario Superior Court of Justice's finding that online sales of prescription eyewear by Essilor Group Canada Inc to Ontario residents violated the Regulated Health Professions Act. The court found that the mere act of delivery did not, in itself, establish a sufficient connection to Ontario so as to bring Essilor's online transactions within the ambit of the act.
In two recent cases, the Federal Court considered procedural decisions in actions under the Patented Medicines (Notice of Compliance) Regulations. In one case, the court ordered that common validity issues in actions relating to Bayer's Xarelto against Apotex and Teva will be heard concurrently. In another case, the court refused to allow the plaintiffs to name additional Teva parties as further defendants in three actions relating to Celltrion's Herzuma, a trastuzumab biosimilar of Roche's Herceptin.
The new pan-Canadian Oncology Biosimilars Initiative aims to ensure appropriate implementation and cost-effective use of therapeutic oncology biosimilars. Separately, Health Canada recently announced that it is collaborating with the Drug Safety and Effectiveness Network on a project to study patients with certain diseases who are taking biologic drugs. The study aims to compare the safety and effectiveness of biosimilar drugs to the reference biologic drug.
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.