The long-awaited amendments to the Patented Medicines Regulations were recently published in Part II of the Canada Gazette. Major changes include the introduction of three new price regulatory factors and a revised schedule of reference countries. Although the new law will not be in force until 1 July 2020, there are immediate implications.
The Department of Health and Human Services (HHS), the Department of Labour and the Treasury have jointly announced that they will not enforce the HHS's recently finalised policy that limits private health plans' use of accumulator programmes to prescription brand drugs for which a medically appropriate generic equivalent is available. Stakeholders should remain alert to any changes in state enforcement policies and consider opportunities to engage with the administration on future revisions.
The Federal Council recently submitted a draft amendment to the Narcotics Act for consultation that aims to facilitate patients' access to cannabis-based treatments. The revised act would allow patients to obtain direct medical prescriptions for cannabis-based treatments with a tetrahydrocannabinol content of more than 1% without having to obtain an exceptional licence from the Federal Office of Public Health.
The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released Issue 8 of its Pharmaceutical Reviews Update announcing revisions to its Procedure and Submission Guidelines for the CADTH Common Drug Review, among other things. The update also announced that the CADTH will no longer review biosimilars through the Common Drug Review or the pan-Canadian Oncology Drug Review.
The Federal Department of Home Affairs recently decided that measures to preserve the fertility of people suffering from cancer will now be covered by compulsory health insurance. Under the new measures, if cancer patients run the risk that a planned treatment will lead to impaired ovarian or testicular function, sperm, egg cells or ovarian tissue can be frozen (so-called 'cryopreservation') and reused after therapy. Cerebrospinal fluid analyses for diagnosing dementia will also be covered.
Beaver Medical Group LP and an affiliated physician recently agreed to pay a combined total of $5 million to resolve allegations that providers had knowingly submitted diagnosis codes that were not supported by medical records in order to inflate reimbursements from Medicare. The settlement reflects the Department of Justice's continuing efforts to use its enforcement power to pursue fraud in the Medicare Advantage space despite recent setbacks.
Health Canada recently announced the final amendments to the Patented Medicines Regulations. The amendments – which represent the first substantive revision to the regulations since their introduction in 1987 – are a significant departure from the existing framework and include new price regulatory factors, updated reference countries and changes in reporting requirements.
Health Canada recently released a revised Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs, which is effective immediately. The revisions include clarifying additions on the requirements for cross-licensed products for an administrative certification form and letter of authorisation, a drug notification form and labelling. Health Canada also recently released an updated Good Label and Package Practices Guide for Prescription Drugs.
Health Canada has announced a consultation on its new draft guidance: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products. The guidance is intended to clarify and outline the factors and circumstances that contribute to rendering a message or activity non-promotional.
Health Canada recently published an annual highlights report for 2018. The report provides information regarding Health Canada drug (for human or veterinary use) and medical device approvals, as well as published safety issues in 2018. Moreover, the Therapeutic Products Directorate and the Biologics and Genetic Therapies Directorate released their Drug Submission Performance Annual Reports for the 2018-2019 fiscal year.
The Federal Council intends to improve access to psychotherapy, especially for children and adolescents, as well as adults in crisis situations. In order to facilitate such access and ensure adequate care, the Federal Council has proposed a change to the existing system which will allow, among other things, psychotherapists to provide their services independently within the compulsory healthcare insurance framework.
To safeguard against potential liability claims under the EU Product Liability Directive, the EU Medical Device Regulation stipulates that medical device manufacturers must have measures in place to provide sufficient financial coverage. However, as medical software can hardly be considered a 'product' under the German Act on Product Liability and the EU Product Liability Directive, it is conceivable that no liability applies under the respective provisions and, therefore, there is no need for financial coverage.
Advanced therapeutic products have been the topic of much debate recently. First, Bill C-97 – which includes amendments to the Food and Drugs Act, including a new framework for advanced therapeutic products – received royal assent. Second, Health Canada opened a consultation to seek feedback on what it should consider when developing new clinical trial regulations as well as implementing the pathway for advanced therapeutic products.
The popular initiative 'Supporting organ donation – saving lives' calls for the introduction of a narrow contradiction solution in order to substantially increase the number of organ donations. At present, the consent solution applies in Switzerland and organ donation is possible only if the deceased agreed during their lifetime to donate their organs. The new contradiction solution would allow organs to be removed from a deceased person if they did not oppose this during their lifetime.
The EU Medical Device Regulation (MDR) was introduced in May 2017 and sets out the legal framework for medical devices in Germany. However, the MDR provides no definition of 'medical software' and limited rules on liability. Medical software liability under the existing regulatory framework requires that medical software be classified as a product; however, this classification is highly controversial and has been widely debated.
The Patented Medicines Prices Review Board (PMPRB) Steering Committee on the Modernisation of Price Review Process Guidelines recently released its final report summarising its deliberations in providing stakeholder feedback on the proposed new framework for the regulation of the prices of patented medicines. The PMPRB will publish draft guidelines for public consultation once it has had an opportunity to review the report and the amended Patented Medicines Regulations have been published.
Most interlocutory decisions under the Patented Medicines (Notice of Compliance) (PMNOC) Regulations are made by prothonotaries of the Federal Court. The first Federal Court of Appeal decision in an appeal of an interlocutory order under the amended PMNOC Regulations was recently issued. The court found that the prothonotary had been entitled to arrive at a view of what was best for the particular proceeding and saw no reviewable error that would justify its intervention.
The Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting – Hospitals) and Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) were recently published. The amendments were enacted further to Vanessa's Law and will require all hospitals to provide specific information relating to serious adverse drug reactions and medical device incidents within 30 days of first documenting the reaction or incident in the hospital.
The Federal Court of Appeal recently granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the board the matter of whether the invention of the patent at hand pertained to Galderma's Differin. The court addressed several issues, including whether the PMPRB had acted unreasonably in limiting its review of the patent to selected portions.
South Africa is in the process of reviewing all existing IP laws, particularly in the context of access to medicines. It appears that the type of changes to be made in respect of the Bolar exception will relate to whether the narrow exception should be extended and, if so, to what. In particular, it is likely that an early experimental research exclusion will be included, such as for pre-clinical research. It remains to be seen whether South Africa's laws may change to allow stockpiling of generic medicines.