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Competition Bureau issues statement regarding off-label use of vaccines

Photo of Kevin AckhurstPhoto of Richard WagnerPhoto of David YiPhoto of Pharma in Brief teamBy Kevin Ackhurst, Richard Wagner, David Yi and Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine.  The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it … Continue reading

Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed … Continue reading

Proposed amendments to Food and Drugs Act introduced in omnibus budget bill

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
The federal government has proposed changes to the Food and Drugs Act (FDA) that would allow the Minister of Health (Minister) to classify products as foods, drugs, cosmetics, devices, or “advanced therapeutic products”; require authorizations to conduct clinical trials; and modify Health Canada’s inspection powers. These changes are included in an omnibus budget bill, the … Continue reading

Budget 2019:  Federal government announces intention to implement recommendations on national pharmacare

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
As we reported the Advisory Council on the Implementation of National Pharmacare recently released an interim report calling for the creation of a national drug agency.  Yesterday, the federal government announced funding to implement this recommendation. Specifically, the government intends to work with partners to implement the following: Create the Canadian Drug Agency — to … Continue reading

Health Canada rejects product-specific suffixes for biosimilars in favour of unique brand names

Photo of Christopher A. GuerreiroPhoto of Daniel DanielePhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Daniel Daniele and Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
Health Canada has decided that all biologic drugs, including biosimilars, will be identified by both their unique brand name and non-proprietary (common) name — without the addition of a product-specific suffix. The ability to distinguish between biologics with the same non-proprietary name is important for pharmacovigilance and to minimize inadvertent substitution of drugs that have … Continue reading

Health Canada consulting on the contents of the Generic Submissions Under Review List

Photo of Christopher A. GuerreiroPhoto of Kristin WallPhoto of Pharma in Brief teamBy Christopher A. Guerreiro, Kristin Wall and Pharma in Brief team on Posted in Uncategorized
On January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list (GSUR) for Abbreviated New Drug Submissions (ANDSs). This type of information was recently added to the list of drug and health product submissions under review (SUR) that Health Canada has … Continue reading

Top 10 Updates on Canadian Market Access, Exclusivity and Pricing Issues

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Pharmaceuticals and life sciences
Norton Rose Fulbright Canada LLP recently published an article on the “Top 10 Updates on Canadian Market Access, Exclusivity and Pricing Issues” for the Food and Drug Law Institute’s March/April 2018 issue of Update Magazine. The article contains an overview of some of the most pertinent changes in market access, exclusivity and pricing that have … Continue reading

Ontario delays implementation of regulations under the Health Sector Payment Transparency Act

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare
Although there has been no public announcement, we understand that the Ontario government has indicated it will not be proceeding with the final approval of regulations developed under the Health Sector Payment Transparency Act (“HSPTA”) before the upcoming election.  Rather, these regulations will be revisited in the fall of 2018. As we reported, Ontario passed … Continue reading

Health Canada releases a cost-benefit analysis survey for labelling changes of natural health products as part of the self-care product framework

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Pharmaceuticals and life sciences
Health Canada is conducting a cost-benefit analysis survey to gather information about the impact of its  proposed changes to the labels of Natural Health Products (NHPs). Interested stakeholders have until May 30, 2018, to complete the survey and provide any other comments. As we reported,  Health Canada is changing the way it regulates non-prescription drugs, … Continue reading

Health Canada to advance self-care products framework under existing regulations

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare
As we reported, Health Canada is proposing to change the way it regulates non-prescription drugs, natural health products and cosmetics, which will now be referred to collectively as “self-care products.” Under the new proposed regime, a product will be regulated by Health Canada based on the risk posed to consumers. Products will be classified as … Continue reading

Health Canada consultation on the naming of biologics including biosimilars

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Pharmaceuticals and life sciences
On January 18, 2018, Health Canada and the Institute for Safe Medication Practices Canada opened a consultation on the naming of biologic drugs (including biosimilars) in Canada. As we reported, the US Food and Drug Administration began affixing a four-letter suffix to the generic name of biosimilar drugs, which is intended to facilitate pharmacovigilance and … Continue reading

Lower prices announced for commonly prescribed generic drugs

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Pharmaceuticals and life sciences
On January 29, 2018, the pan-Canadian Pharmaceutical Alliance (pCPA) and the Canadian Generic Pharmaceutical Association issued a joint statement announcing that effective April 1, 2018, 20 commonly prescribed generic drugs will be further reduced to 10% of the cost of the reference brand product.  The list of drugs reimbursed at 18% has also grown and … Continue reading

Ontario legislation requiring disclosure of payments to physicians receives Royal Assent

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
On December 12, 2017, Bill 160 passed third reading and received Royal Assent.  Included in Bill 160 is the Health Sector Payment Transparency Act (the “Act”). This Act will come into force at a later date to be determined by the government. The stated purpose of the Act is to require the reporting of information … Continue reading

PAAB Announces New Code of Advertising Acceptance

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
The Pharmaceutical Advertising Advisory Board (PAAB) has announced an updated Code of Advertising Acceptance (Code).  The new Code will be implemented beginning on January 1, 2018. The primary change is to the Code’s format.  It will only be available online and will allow keyword searching and filtering code provisions by core principle.  Other changes include … Continue reading

Ontario health sector disclosure legislation referred to committee

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
As we reported, Ontario has introduced legislation that will require pharmaceutical and medical device manufacturers to disclose financial relationships with healthcare professionals and organizations to the government. The legislation has passed second reading and has been referred to committee.  The Standing Committee on General Government will hold public hearings on November 15, 16, 20, and … Continue reading

Federal Court confirms innovator must be named as respondent when PM(NOC) Regulations engaged

Photo of Judith RobinsonPhoto of Pharma in Brief teamBy Judith Robinson and Pharma in Brief team on Posted in Intellectual property, Pharmaceuticals and life sciences
The applicant brought a judicial review of Health Canada’s decision that its new drug submission triggered the PM(NOC) Regulations, and moved for a confidentiality order. The Federal Court has now upheld a decision requiring notice of the motion to another innovator company, confirming that the second innovator has a legal interest in the determination of … Continue reading

Ontario introduces legislation requiring disclosure of payments to physicians

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations. The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers to periodically disclose details about … Continue reading

Health Canada consultation on draft guidance documents implementing Vanessa’s Law

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Pharmaceuticals and life sciences
As we reported, the Government of Canada recently published draft regulations under Vanessa’s Law that set out additional reporting requirements for manufacturers, based on the actions of foreign regulators, and provide details regarding the Minister of Health’s powers to require tests, assessments and studies of a post-market drug authorization. Health Canada has now published two … Continue reading

Ontario considers requiring disclosure of drug company payments to healthcare providers

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Life sciences and healthcare, Pharmaceuticals and life sciences
The Government of Ontario has announced it is consulting with patients, healthcare providers, and the pharmaceutical and medical devices industries about current regulations and guidelines that govern the disclosure of payments from the private sector to healthcare professionals. Although some innovative pharmaceutical companies already voluntarily disclose payments to healthcare providers, Ontario is assessing what additional … Continue reading

Supreme Court dismisses leave to appeal regarding notice requirements under section 5 of the PM(NOC) Regulations

Photo of Kristin WallPhoto of Judith RobinsonPhoto of Pharma in Brief teamBy Kristin Wall, Judith Robinson and Pharma in Brief team on Posted in Pharmaceuticals and life sciences
As we reported, Janssen Inc. et al. filed an application for leave to appeal with the Supreme Court of Canada on December 9, 2016 with respect to the Federal Court of Appeal’s decision addressing a generic manufacturer’s notice obligations when obtaining a notice of compliance (NOC) by way of a cross-referenced drug submission. On June … Continue reading

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Pharmaceuticals and life sciences
Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide). The GLPP Guide was released as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling … Continue reading

Health Canada proposes regulations allowing importation of drugs not yet available in Canada for an urgent public health need

Photo of Pharma in Brief teamBy Pharma in Brief team on Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences
Health Canada has proposed regulations that will amend the Food and Drug Regulations to allow for importation of drugs that have not yet received regulatory approval from Health Canada. The new regulations will provide access to drugs that address an urgent public health need provided they have been approved in the United States, the European … Continue reading
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