Canada: Pharma In Brief - Canada: Quebec Life Sciences And Healthcare Update (September 2013)

Co-author: Erika Bergeron-Drolet

Bill no. 41, An Act to amend the Pharmacy Act, once in force, will entitle Québec pharmacists to perform a number of services that were traditionally reserved for physicians. Bill no. 41 was originally sponsored by Yves Bolduc, the Minister of Health and Social Services at the time it was introduced and was adopted by the National Assembly of Québec on December 8, 2011. The Bill and related regulations were to come into force September 3, 2013, but given the ongoing negotiations regarding certain issues, its implementation has been postponed. An order in council was issued on August 22, 2013 to defer the coming into force of the Bill and related regulations to a date to be determined.

Under the Bill, pharmacists will be permitted to extend prescriptions, subject to certain limitations, prescribe medications when no diagnosis is required, and prescribe and interpret certain laboratory tests. In accordance with newly enacted regulations, pharmacists may adjust a prescription, substitute one medication for an equivalent in case of a shortage, prescribe medications for mild medical conditions when the diagnosis and the treatment are already known and administer medication to show patients its proper usage. The latter four new activities can only be performed by a pharmacist after completion of relevant training. Nearly 5,000 of the 8,300 Québec pharmacists have already completed such training, while others are expected to complete before the end of 2013.

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New Legislative Provisions with Respect to Research in Quebec

Author: Olga Farman

On March 28, 2013, Réjean Hébert, the Minister of Health and Social Services and minister responsible for Seniors, introduced at the National Assembly Bill n° 30 aimed at amending certain provisions of the Civil Code of Québec (C.c.Q.) and An Act Respecting Health Services and Social Services (R.S.Q., c. S 4.2) (ARHSSS). The Bill, entitled An Act to amend the Civil Code and other legislative provisions with respect to research (the Act) received assent and came into force on June 14, 2013. The Act modernizes the legislative framework relating to research, which was last modified in 1998. More specifically, the Act modifies certain provisions of the Civil Code section on "care" (including sections 21 through 24), as well as section 34 of the ARHSSS regarding the complaints procedure related to institutions that carry on research activities in the Province of Quebec.

The amendments made to the Civil Code and the ARHSSS soften a number of measures pertaining to consent to research when health risks are minimal in order to facilitate the advancement of knowledge while fostering research development. Indeed, said legislative changes are part of a harmonization effort with nationally and internationally recognized ethical standards.

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Update on Proposed Act respecting End-of-life Care

Author: Greg Bordan

When the members of the National Assembly return from summer recess, they will be asked to vote on Bill 52, which deals with end-of-life care. Tabled on June 12, the Bill has received considerable attention because it provides a legal framework for euthanasia, a first in Canada. If the bill becomes law, "medical aid in dying" would become available to seriously ill patients whose request can be justified by their condition. This reflects one of the main objectives of the Bill: to recognize the primacy of the freely expressed wishes and consent of patients in Quebec's healthcare system.

The Bill would also make it mandatory to offer patients palliative care in institutions and at home. Healthcare institutions such as hospitals and CLSCs would be required to adopt a clinical program for end-of-life care. The Government has also reiterated recent announcements that it would invest $15 million in palliative care on a recurring basis.

If the Bill becomes law, it will raise a constitutional question: is medical help in dying a public health matter falling within provincial jurisdiction or, in pith and substance, does it trench on a federal matter, already addressed in the Criminal Code? To be continued.

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Class Action Against Pharmaceutical Company Denied Certification

Author: Dominic Dupoy

On June 27, 2013, the Québec Superior Court refused to allow a class action against Hoffman-La Roche Limited ("Roche") to proceed. The class action would have represented all Quebecers who have developed some form of inflammatory bowel disease allegedly as a result of taking the drug Accutane. The motion was filed by Mr. Yann Lebrasseur, who claims to have developed Crohn's disease as a result of taking Accutane.

The Court dismissed the motion on the basis that, among other things, it does not satisfy the test provided for at subsection 1003(b) of the Code of Civil Procedure (R.S.Q. c. C-25) as no scientific evidence showing or suggesting a causal link between the use of the drug and the onset of Crohn's disease was put forward. Furthermore, the drug's side effects had been properly disclosed by Roche in its monograph.

In addition, the Court found that several issues raised in the motion were more individual in nature and did not satisfy subsection 1003(a) of the Code of Civil Procedure, namely that the recourses of the members of the class action must raise identical, similar or related questions of law or fact.

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Update : When is Prior Authorization needed to Tender on a Contract with a Public Body?

Author: Greg Bordan

Quebec's new Integrity in Public Contracts Act requires contractors wishing to tender on a contract with a public body to receive prior authorization from the Autorité des marchés financiers (AMF). The government prescribes which categories of contract are subject to such prior authorization.

"Public bodies" include hospitals and joint procurement groups, such as non-profit buying groups used by hospitals to purchase drugs, and all other "health and social services agencies and public institutions referred to in the Act respecting health services and social services."

To date, AMF authorization is required only for construction and service contracts of over $40 million (as well as certain construction contracts with the Ville de Montréal). No authorization is required for supply contracts. Therefore, at present, drug manufacturers wanting to tender on drug supply contracts with public bodies do not need to obtain authorization.

However, tenders on mixed service and supply contracts, meaning contracts that have a supply component and a service component, are subject to AMF authorization if the total contract value is over $40 million.

The AMF expects that in the near future the government will lower the threshold to $10 million for construction and service contracts and sub-contracts (or mixed contracts).  In anticipation of this, the AMF is encouraging enterprises intending to bid on such contracts over the coming months to complete and file an application for authorization in advance and without delay.

Because the government may continue extending the categories of contracts subject to its pre authorization process to include, notably, supply contracts, it is important to monitor developments.

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