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.
The Federal Department of Home Affairs recently decided that two new autologous cell therapies (CAR-T therapies) for the treatment of blood and lymph gland cancer will in future be covered by compulsory healthcare insurance. Further, preventive investigations of colorectal cancer will be exempted from the franchise in the Cantons of Fribourg and Basel-Stadt. In addition to these changes, a number of other adaptations have been made to the Healthcare Benefits Ordinance and its annexes.
The Lausanne University Centre for General Medicine and Public Health, in close cooperation with the Swiss Biobanking Platform, recently commenced the pilot phase of the so-called 'Swiss health study', which aims to determine which chemicals accumulate in the human body. The pilot phase is supported by the Federal Office of Public Health.
Due to the COVID-19 emergency and the consequent lockdown that is affecting most non-essential services in Italy, including some healthcare services, the Italian Medicines Agency recently issued guidance for sponsors, non-profit organisations and contract research organisations involved in clinical trials. The guidance tackles urgent needs that sponsors are experiencing in clinical trials due to restrictions on patients' access to trial sites.
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.
The current circumstances are unsettling for many reasons, not least because there is still no approved vaccination or treatment for the novel coronavirus (COVID-19). Reflecting the collaborative approach recently called for by the European Medicines Agency, the UK Medicines and Healthcare Products Regulatory Agency has indicated that it stands ready to support researchers, manufacturers and other regulators to develop medicinal products to fight and prevent the spread of COVID-19.
The Data Protection Authority (DPA) has approved a draft act that would prohibit life and health insurers from processing data from policyholders' health trackers. Notably, data from health trackers and apps can still be used for any other insurance that does not qualify as life or health insurance. However, in its advice, the DPA appears to acknowledge that all data coming from health trackers and lifestyle-related apps is likely to be considered health data.
The popular nursing care initiative 'For Strong Nursing Care' is calling for more nursing staff and quality safeguarding in nursing care. The Swiss parliamentary Commission for Social Security and Health recently presented an indirect counterproposal to this popular initiative. The counterproposal adopts a number of the initiative's important demands and aims to counter the nursing staff shortage and increase nursing staff skills with an educational campaign.
The Canadian Agency for Drugs and Technologies in Health and the Ontario Drug Policy Research Network (ODPRN) have released reports examining utilisation trends of innovator biologics and biosimilar versions of infliximab and etanercept, as well as the innovator biologic adalimumab, with regard to rheumatic conditions and inflammatory bowel disease in Ontario. This article examines the takeaway messages from the ODPRN report.
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.
In 2019 the Federal Court of Appeal dismissed Millennium Pharmaceuticals' and Janssen's appeal of a decision granting Teva's claim for compensation under Section 8 of the Patented Medicines (Notice of Compliance) Regulations. Millenium Pharmaceuticals and Janssen have now applied to the Supreme Court of Canada for leave to appeal.
A new act amending various legal provisions concerning shortages of medicinal products was recently published in the Official Gazette. Arguably, the new legislation does not prevent pharmaceutical companies from applying quotas, provided that they do not affect the public service obligation of wholesaler-distributors (also known as 'full-line wholesalers'). In addition, the act arguably imposes no general obligation on pharmaceutical companies to supply retail pharmacies directly.
The consultation period for the Patented Medicine Prices Review Board's (PMPRB's) draft guidelines operationalising the amended Patented Medicines Regulations recently ended, after two extensions. Further, the PMPRB has released the presentations from its January 2020 patentee webinar, December 2019 industry forum and December 2019 civil society forum.
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 Patented Medicine Prices Review Board recently released the Meds Entry Watch 2018, which analyses information about medicines approved by the US Food and Drug Administration, the European Medicines Agency or Health Canada in 2017 and 2018. One of the key findings is the continued upward trend in the entry of high-cost products (eg, orphan drugs and oncology products).
Cannabis-containing finished medicinal products have been available on prescription in Germany for some time. In 2017 the amendment of various acts permitted the state-controlled cultivation of cannabis and allowed the production of cannabis-containing medicinal products in pharmacies. This article provides an overview of the legal framework applicable to cannabis products – especially cannabis-containing medicinal products – and the current discussions and developments relating thereto.
The Canadian Institute for Health Information recently published statistics on drug spending, finding that in 2018 approximately 40% of drug spending was spent on 2% of beneficiaries. Of this 2%, three out of five individuals used a drug therapy that cost C$10,000 or more per year (eg, antivirals or biologics for rheumatoid arthritis or Crohn's disease).
There have been a number of key developments in South African life sciences law relating to cannabis in recent years, including amendments to the Medicines and Related Substances Act 1965, such that products which contain only cannabidiol – when intended for therapeutic purposes – can now be obtained from a pharmacist by prescription. Further, cannabis-related trademark applications will now be accepted on the condition that the products comply with the standards set by the health minister.
There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including significant amendments to the Patented Medicines Regulations, a number of biosimilars developments relating to approvals, pending submissions and naming and the second anniversaries of the certificate of supplementary protection regime and the Patented Medicines (Notice of Compliance) Regulations.
The United States, Mexico and Canada recently signed amendments to the US-Mexico-Canada Agreement (USMCA). The original USMCA was signed on 30 November 2018. The recent amendments have removed a provision, such that Canada can maintain its current data protection laws which provide an eight-year data protection term, with a possible six-month paediatric extension, for all pharmaceutical products, including biologics.