Bill 92 was introduced to the National Assembly of Quebec on April 27, 2016, by the Minister of Health and Services to amend various acts such as the Health Insurance Act, the Hospital Insurance Act, the Act respecting prescription drug insurance, the Act Respecting Administrative Justice, the Act respecting the Régie de l'assurance maladie du Québec and the Act Respecting Health Services and Social Services.
An Act respecting the Régie de
l'assurance maladie du Québec
This act would be amended1 to grant the Régie de
l'assurance maladie du Québec (Board) inspection powers
to verify compliance with the Act respecting the Régie de
l'assurance maladie du Québec, the Health Insurance
Act and the Act respecting prescription drug insurance and the
regulations.
The inspection powers granted would allow the Board to enter any
place where a drug manufacturer or wholesaler accredited by the
minister exercises functions or carries out activities, and obtain
information and documents relating to the functions exercised or
activities carried out by these drug manufacturers or wholesalers.
The Board may also authorize any person to act as an inspector for
the purpose of ensuring compliance with the law, and to undertake
such inspection.2
The health professional, dispenser or drug manufacturer or
wholesaler would then have to make documents to which it has
custody or control available to the inspector, and even to
facilitate such examination3.
Furthermore, any person may be required to provide any information
related to the functions exercised or activities carried out by a
health professional, a dispenser, drug manufacturer or wholesaler
accredited by the minister4. Additionally, the inspector
may, by registered mail or in person service, require from any
person any information or documentation relating to the application
of relevant laws.5
Within the scope of these inspections or investigations, no person could refuse to communicate to the Board any financial information or document concerning the activities carried out by a drug manufacturer or wholesaler accredited by the minister. Anyone refusing to communicate such information or document would be guilty of an offence and thus liable for a fine of $5,000 to $50,000. The Board would even have the right to apply to the Superior Court to obtain an injunction in respect of any matter relating to an act under the Board's administration.
An Act respecting prescription drug
insurance
This act would be amended6 to allow the Board to recover
from a drug manufacturer or wholesaler an amount corresponding to
15% of the non-authorized rebates, gratuities or other benefits
extended by the manufacturer or wholesaler7. Monetary
administrative penalties (e.g. $2,500 to $12,500) and penal
offences would thereby be prescribed for cases where: (i) a
manufacturer or wholesaler extends such benefits, or (ii) a
pharmacist receives such benefits8. Furthermore, the
minister would be entitled to prescribe, by regulation, the
monetary administrative penalties (up to $2,500) applicable by the
Board for any other failure by a manufacturer or wholesaler to
comply with a condition or commitment prescribed by
regulation9.
It is also worth mentioning that if after an investigation the
Board believes that rebates, gratuities or other benefits were
granted contrary to the conditions or commitments prescribed, then
the manufacturer may have to pay back these amounts (in addition to
the administrative penalty)10.
Other acts
Additional inspection powers would be granted by the Board under
other acts to recover any amounts obtained in contravention to the
law and to prosecute healthcare professionals and third parties who
committed such violations.
***
Bill 92 has not yet been adopted by the National Assembly and
therefore is not in force. Some consultations are taking place at
the moment. Various organizations such as l'Ordre des
pharmaciens du Québec (the OPQ) have submitted briefs in
which they present their views on the subject examined during
consultations held by the parliamentary committee. However, the
National Assembly is not bound by these briefs. Until adopted, Bill
92 is still subject to being amended in light of the documents
filed by any stakeholder (such as the brief prepared by the OPQ) or
of the points raised by them during the special consultations and
sittings, such as the one that took place on May 12 during which
the OPQ made representations.
Footnotes
1 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, ss. 39-42
2 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, s. 39
3 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, s. 39
4 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, s. 39
5 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions s. 39
6 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, ss. 32-33, 35
7 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, s. 31
8 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, s. 33
9 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, s.32
10 An Act to extend the powers of the Régie de
l'assurance maladie du Québec and to amend various
legislative provisions, ss. 32.
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