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Healthcare & Life Sciences updates
Contributed by Preslmayr Attorneys at Law
Cannabidiol in food and cosmetics
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.
Social security system to undergo restructure – but will it achieve cost savings?
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.
Amendment to Act on the Medical Profession
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.
Misleading comparative advertising of drugs
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
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.
More updates for Austria
Contributed by ALTIUS
Anti-tampering devices – fading boundaries of parallel trade?
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.
Invalidated SPC retains prima facie validity in preliminary injunction proceedings
A pharmaceutical company requested a preliminary injunction against a generic manufacturer based on one of its invalidated supplementary protection certificates. An appeal court granted the injunction, but the generic manufacturer appealed to the Supreme Court. The court's decision is notable for its distinction between the authority and the force of res judicata, and the implications of this distinction for rights holders.
GMO trial gets green light despite formal invalidity
The government has implemented a strict regulatory framework for genetically modified organism field trials. But what happens when one of the players fails to respect the rules? Does it affect the valid work that has already been done by others? These questions recently arose before the Ghent Court of First Instance in the context of expedited civil proceedings initiated by Greenpeace against the Belgian state.
Mock-ups no proper notification of repackaged pharmaceutical parallel imports
The Brussels Court of Appeal recently ruled that a parallel importer did not properly notify a pharmaceutical trademark holder when it provided a two-dimensional mock-up of the outer packaging, rather than an actual sample, of the repackaged pharmaceutical as it would be presented on sale. The decision provided much-needed clarity, as the first instance court had issued contradicting decisions on the matter.
Doctors not easily misled? Brussels court decides on pharmaceutical advertising
The Brussels Commercial Court has dismissed Pfizer's misleading claims directed against an advertisement for a generic product marketed by Eurogenerics, as well as Eurogenerics's counterclaim regarding the marketing of Pfizer's own generic product. The court's relaxed views on doctors' awareness of the regulations on reimbursement and their implications will be of interest to pharmaceutical marketeers.
Health sector transparency laws
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
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
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
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
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.
More updates for Brazil
Contributed by Smart & Biggar/Fetherstonhaugh
National pharmacare update: publication of advisory council's final report
The minister of health recently published the final report from the Advisory Council on the Implementation of National Pharmacare. The council has recommended that Canada implement universal, single-payer, public pharmacare by enacting new legislation and proceeding in a stepwise approach to implementation.
Federal Court upholds PMPRB's pricing decision regarding Alexion's Soliris
The Federal Court recently dismissed Alexion's application for judicial review of a Patented Medicines Price Review Board (PMPRB) panel's decision that Soliris (eculizumab) had been sold at an excessive price and its order fixing the amount of the payment to offset excess revenues (C$4.2 million). The application was dismissed on the grounds that, among other things, the PMPRB had not been unreasonable in ordering payment of excess revenues based on the highest international price comparison.
Guidance document on reporting adverse reactions to marketed health products
Health Canada has published its Overview of the Reporting Adverse Reactions to Marketed Health Products – Guidance Document for Industry. The guidance document provides market authorisation holders with assistance on how to report adverse reactions to pharmaceutical drugs, biologics, radiopharmaceutical drugs and natural health products.
Supreme Court of Canada denies Apotex leave to appeal in two cases
The Supreme Court of Canada has denied Apotex leave to appeal in two recent cases. In the first case, Apotex sought leave to appeal a decision of the Ontario Court of Appeal permitting Sanofi and Schering to amend their defences to claims relating to ramipril. In the second case, Apotex sought leave to appeal a decision of the Federal Court of Appeal relating to damages awarded to Eli Lilly in respect of Apotex's infringement of process patents relating to cefaclor.
Proposed regulations set to amend process for sale of drugs for medical emergencies
Two sets of proposed amendments to the Food and Drug Regulations were recently published and contain provisions which would streamline the process for providing access to unauthorised drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products.
More updates for Canada
General Healthcare System contributions
As of 1 March 2019, employees, pensioners, state officials and income earners in Cyprus must contribute 1.7% of their income to the General Health System, while self-employed individuals must contribute 2.55% of their income. Private employers must also make General Health System contributions of 1.85% on emoluments made to employees, while the state must make an additional contribution of 1.65% of the incomes of employees, self-employed individuals, pensioners and government officials.
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Smart & Biggar/Fetherstonhaugh (167)
Sidley Austin LLP (78)
Preslmayr Attorneys at Law (36)
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ALTIUS (5)
Walder Wyss (3)
Eversheds Sutherland (Germany) LLP (1)
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