The African Union (AU) recently published a COVID-19 vaccine strategy. The strategy was announced in a communique issued by the AU ministers of health and heads of delegation following a virtual conference on 24 and 25 June 2020. Access to medicine in Africa is a recurring concern and it may be an opportune moment to use the response to the COVID-19 pandemic as a blueprint to secure future access to pharmaceuticals – including vaccines – for Africans.
In March 2020 the legislature enacted the COVID-19 Measures Act, which authorised the Federal Ministry for Social Affairs, Health, Care and Consumer Protection to enact regulations prohibiting access to business premises to the extent necessary to prevent the spread of COVID-19. Based on this provision, the ministry enacted the COVID-19 Measures Regulation; however, the Constitutional Court recently overruled Sections 1, 2, 4 and 6 of the regulation.
Recent case law suggests that, although medical society and other expert committee guidelines are non-binding, they may serve as evidence to specify current medical standards. However, as they cannot be considered on the same level as medical standards, the application of such guidelines to specific cases requires an expert assessment.
A landmark Supreme Administrative Court decision concerning Onpro Kit, a medicine for treating chemotherapy-induced leucopenia, provides further clarity on the inclusion of medicines in the Main Association of Austrian Social Security Institutions' reimbursement code. The court examined the special circumstances in which a medicine is inappropriate for use in the course of medical treatment because it is designated for use predominantly in hospital treatments.
The Ministry of Health recently provided Parliament with a draft amendment to the Health Telematics Act for public consultation. The proposal aims to remedy a number of challenges relating to Austria's existing immunisation system through the introduction of electronic immunisation cards and a central register of vaccinations.
The Austrian professional rules for dentists are strict and restrictive and permit advertising only within tight limits. Recent case law suggests that the Chamber of Dentists is highly active in enforcing both the Directive on Advertising and the Dental Act. Under the directive, print media ads must not exceed quarter of a page and dentists must not use unobjective advertising (eg, ads which promise patients non-dental advantages or services).
The Belgian Competition Authority's (BCA's) latest note reiterates that competition law rules concerning merger control fully apply to the creation of local hospital networks as required under the Act of 28 February 2019. Although hospitals seem largely unaware of the obligations under the merger control rules attached to such forms of cooperation, they should consider that the BCA is paying more attention to the sector and that significant penalties may be incurred for non-compliance.
Parliament recently adopted a new act to increase the transparency of managed entry agreements (MEAs) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance. MEAs stipulate confidential compensation mechanisms for the government regarding the publicly listed price and reimbursement basis of the medicines concerned.
The minister of economic affairs recently adopted a ministerial decree which restricts the retail and wholesale distribution of certain types of personal protective equipment and medical devices used for treating COVID-19 patients. Further amendments were implemented by ministerial decrees on 27 March 2020 and 7 April 2020. This article provides a short description of the relevant trade restrictions followed by a legal analysis in light of fundamental principles of EU law.
The COVID-19 outbreak has created an urgent need for certain goods, including medicines and medical devices. However, do public authorities (eg, hospitals) still need to follow the complete public procurement procedures to procure these urgently needed goods? In cases of extreme urgency, such as that presented by the COVID-19 pandemic, contracting authorities can use the negotiated procedure without publication to place tenders.
The COVID-19 crisis has highlighted the fact that an EU common policy in the healthcare sector is virtually non-existent, especially in respect of medicinal product pricing and reimbursement. This article illustrates the need for national pricing authorities to consider that their policies could have unintended consequences and cross-border effects. Otherwise, national measures risk backfiring, as seems to have happened with the Belgian authorities' most recent attempt at further reducing medicinal product prices.
The Federal Court recently issued its decision on an application for judicial review of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements). The court ruled that Section 3(4), which would expand price calculation requirements in Section 4(4) of the Patented Medicines Regulations to encompass information beyond the first point of sale, was invalid. This article looks more closely into the court's decision and its implications.
The Patented Medicine Prices Review Board recently announced that the amended Patented Medicines Regulations will now come into force on 1 January 2021. Further, a revised set of draft guidelines will be published during the week of 15 June 2020, followed by a 30-day consultation period.
The Federal Court recently issued the first decision under the amended Patented Medicines (Notice of Compliance) Regulations. In the decision, Pfizer was successful in establishing obviousness of the asserted claims of Canadian Patent 1,341,537 relating to filgrastim (Amgen's NEUPOGEN and Pfizer's biosimilar product NIVESTYM).
Most of the final amendments to regulations made under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act came into effect on or before 1 January 2020, following public consultations. One notable change compared with the proposed amendments is the removal of the financial cap on ordinary commercial term benefits. Further, private label products will no longer be prohibited from being designated as a listed drug product or interchangeable.
In 2018 the Federal Court found that Kennedy's new use patent for infliximab (Janssen's Remicade) was valid and had been infringed by Hospira's biosimilar Inflectra. However, in January 2020 the Federal Court of Appeal released a decision remitting for reconsideration by the trial judge certain issues relating to the validity of Canadian Patent 2,261,630.
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.