{"id":18957,"date":"2020-07-13T09:00:21","date_gmt":"2020-07-13T13:00:21","guid":{"rendered":"https:\/\/www.benefitscanada.com\/news\/pmprb-changes-within-scope-of-patent-act-rules-federal-court-in-judicial-review-147947"},"modified":"2020-07-13T09:00:21","modified_gmt":"2020-07-13T13:00:21","slug":"pmprb-changes-within-scope-of-patent-act-rules-federal-court-in-judicial-review","status":"publish","type":"post","link":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/2020\/07\/13\/pmprb-changes-within-scope-of-patent-act-rules-federal-court-in-judicial-review\/","title":{"rendered":"PMPRB changes within scope of Patent Act, rules federal court in judicial review"},"content":{"rendered":"
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Kelsey Rolfe<\/span> | July 13, 2020 <\/p>\n

The Federal Court has upheld reforms to the Patented Medicines Pricing Review Board that updated the board\u2019s reference countries for drug pricing and required it to review three new economic factors when determining whether patented medicines are excessively priced.<\/p>\n

The court ruled against an argument by Innovative Medicines Canada and 16 pharmaceutical companies in their application for judicial review that the changes fell outside the scope of the Patent Act, which governs the PMPRB.<\/p>\n

\u201cI find the purpose of the amendments <\/em>related to the new mandatory factors . . . <\/em>and the [reference countries] under section 6 . . . [are] sufficiently connected to and consistent with the purpose of the patented medicines regime in the context of the Patent Act: protecting consumers from the abuse of excessive pricing,\u201d wrote Judge Michael Manson in his decision.<\/p>\n

Read: What will PMPRB drug pricing changes mean for plan sponsors?<\/a><\/strong><\/p>\n

The reforms will update Canada\u2019s reference countries for comparing its prices internationally. They\u2019ll remove Switzerland and the U.S. \u2014 the only two countries in the world with higher patented drug prices than Canada \u2014 and add Australia, Belgium, Japan, the Netherlands, Norway and Spain, which all have lower drug prices.<\/p>\n

They also make it mandatory for the board to consider the pharmacoeconomic value of a patented drug, the size of the market for it in Canada and the country\u2019s gross domestic product and GDP per capita when determining whether its price is excessive.<\/p>\n

However, Manson did rule that a section of the amendments that would require patentees to report the market price of the medicine in Canada and other markets, including any possible rebates, instead of the inflated sticker price, falls outside of the scope of the act.<\/p>\n

In mid-June, the PMPRB released a new draft of its guidelines<\/a> and launched a 30-day written consultation period. The amendments, which were initially slated to come into effect on July 1, have been delayed to Jan. 1, 2021.<\/p>\n

Read: PMPRB publishes new draft guidelines, launches 30-day consultation<\/a><\/strong><\/p>\n

In an emailed statement, the PMPRB said it was reviewing the impact of the decision but \u201cdoes not believe any substantive changes to the June 2020 draft guidelines are required as a result.\u201d<\/p>\n

In a statement posted to its website, Innovative Medicines Canada said it\u2019s reviewing the decision in consultation with its members. \u201cWe remain deeply concerned about the negative impact the amended patented medicines regulations <\/em>will have on Canadians\u2019 access to affordable, innovative medicines and on the country\u2019s ability to attract investment to our life-sciences sector. The innovative medicines industry has demonstrated its vital role in the health and well-being of Canadians through the COVID-19 crisis and we must foster a regulatory environment that encourages it to grow and thrive.\u201d<\/p>\n

In another case making its way through the courts, five major pharmaceutical companies filed a constitutional challenge<\/a> to the PMPRB changes in August 2019, arguing that the federal government doesn\u2019t have the constitutional authority to regulate the pricing of medicines or manage health-care systems as those issues fall within provincial jurisdiction.<\/p>\n

Read: Pharma companies launching challenge to PMPRB changes<\/a><\/strong><\/p>\n

Read the full article at BenefitsCanada.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Kelsey Rolfe | July 13, 2020 The Federal Court has upheld reforms to the Patented Medicines Pricing Review Board that updated the board\u2019s reference countries for drug pricing and required it to review three new economic factors when determining whether patented...<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[],"tags":[],"jetpack_featured_media_url":"","_links":{"self":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/18957"}],"collection":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/comments?post=18957"}],"version-history":[{"count":0,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/posts\/18957\/revisions"}],"wp:attachment":[{"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/media?parent=18957"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/categories?post=18957"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blog.lifeinsurance-orleans.ca\/index.php\/wp-json\/wp\/v2\/tags?post=18957"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}