Article – détails
Projet de loi 102, la suite : L’Ontario annonce des modifications proposées à la législation en matière de remboursement des médicaments et d’interchangeabilité des médicaments
16 avril 2010
Shanon O.N. Grauer
Le 8 avril 2010, le ministère de la Santé et des Soins de longue durée a publié à des fins de commentaires des modifications proposées aux règlements pris en application de la Loi sur le régime de médicaments de l’Ontario (LRMO) et de la Loi sur l’interchangeabilité des médicaments et les honoraires de préparation (LIMHP) qui auraient une incidence importante sur la manière dont les pharmacies, les fabricants de médicaments (principalement les fabricants de médicaments génériques) et les grossistes exercent leurs activités en Ontario. Ces modifications proposées font état des améliorations supplémentaires apportées dans le cadre de la dernière grande ronde de modifications du gouvernement de l’Ontario en 2006 aux termes du projet de loi 102.
La LRMO régit le remboursement des frais de médicaments aux « personnes admissibles ». Ce régime public de remboursement des médicaments constitue un pourcentage important du total des ventes de médicaments dans la province. La LIMHP régit la vente des médicaments qui sont « énumérés » comme étant « interchangeables » par le gouvernement et permet aux pharmaciens d’exécuter une ordonnance visant un médicament (ventes privées ou publiques) avec un médicament « interchangeable ». Sous réserve d’une période de consultation publique de 30 jours, bon nombre de ces modifications doivent entrer en vigueur le 15 mai 2010, alors que d’autres entreront progressivement en vigueur au cours d’une période de deux à quatre ans.
Aux termes de la LIMHP et de la LRMO, une période de consultation de 30 jours à compter de la date de publication de l’avis doit être tenue, période au cours de laquelle le public peut soumettre des commentaires écrits relativement aux règlements proposés. Le ministre a demandé à recevoir les commentaires écrits sur les règlements proposés visant à modifier le règlement pris en application de la LIMHP et le règlement pris en application de la LRMO avant 17 h le 8 mai 2010.
La suite du texte sera disponible en français sous peu.
The following are highlights of the proposed changes:
1. Changes to Professional Allowance Limits
For ODBA-reimbursed drugs, professional allowance limits have effectively been lowered by 15%. Under the proposed amendments, pharmacies would only be permitted to receive professional allowances in the amount of 5% of the value of drugs reimbursed under the ODBA, which is down from a previous 20% of such drug sales.
The proposed changes also introduce limits on professional allowances that pharmacies may receive for private sales of "interchangeable drugs" under the DIDFA. In the first year, professional allowances are limited to 50% of interchangeable product private sales (May 15, 2010), which is reduced to 35% in the second year (April 1, 2011), and 25% in the third year (April 1, 2012).
2. Changes to Prices for Generic Drugs
The price of interchangeable drugs under the ODBA has been reduced from the current limit of 50 to 25%. In effect, subject to the exemptions below, the proposed drug benefit price (DBP) must be less than or equal to 25% of the price of the original product (i.e., the innovator product).
This 25% rule would not apply in the following circumstances:
Despite these pricing restrictions, under the ODBA the Executive Officer (EO) is permitted to negotiate any price for an interchangeable drug with a manufacturer, subject to the following restrictions:
- For situations (1) and (2) (where (3) does not apply), the price of an interchangeable product cannot be higher than the original product.
- For situation (1), when the conditions no longer exist, the price will revert back to the 25% rule.
- For situation (3), the price can be higher than the original product only when it is in the public interest having regard to the matters set out in subsection 22(2) of the ODBA and anything else the EO considers relevant.
Under the DIDFA, the proposed amendments introduce a requirement that the DBP for all interchangeable designated drugs that are also listed under the ODBA, whether sold in private or public markets, will be the same and that those interchangeable drugs sold on the private market cannot be sold at a price higher than the DBP. The provisions under the DIDFA are being phased in over three years. Effective May 15, 2010, the price of the drug under the DIDFA for "non-eligible" persons (i.e., private sales) must not be greater than 50% of the original product as set out in the Formulary. However, if the price is lower than the DBP, the interchangeable product can be sold at the DBP. The 50% level will go down to 35% on April 1, 2011. On April 1, 2012, the price of such private sale interchangeable drugs will not be higher than the DBP (i.e., shall not be higher than prices for eligible persons under the ODBA).
3. Changes to Reimbursed Mark-Ups and Dispensing Fees under the ODBA
Currently under the ODBA, the government will reimburse pharmacies a flat 8% mark-up of the DBP for drugs sold to eligible persons and a dispensing fee of $7.00. This applies to all pharmacies.
The proposed amendments introduce categories for pharmacies — 1, 2, 3, or 4 — which are based on pharmacy location, number of pharmacy services in geographic area, the distance between pharmacies and volume of claims submitted for payment under the ODBA. The definitions of these categories have not yet been set and the EO has specifically requested comments on these categories.
The proposed changes set different mark-ups and dispensing fee limits depending on pharmacy category. Categories 2, 3, and 4 are intended for pharmacies located in more rural and underserviced areas and are permitted higher mark-ups and dispensing fees.
The mark-up for category 1 pharmacies will remain at 8%, while the mark-up for categories 2 to 4 will be set at 10%. However, if the pharmacy has not purchased at least 75% of the products it supplies from a comprehensive wholesaler, the mark-up will be only 5%. In no event, will a mark-up of more than $125.00 per dispensed product be reimbursed by the government.
For dispensing fees, effective May 15, 2010, the reimbursed dispensing fee will be $8.00 for category 1 pharmacies, going up to $11.00 for category 4 pharmacies. These amounts are increased annually so that by April 1, 2014, they will be $8.83 and $12.14, respectively.
4. Revised Definition of Rebate under the ODBA and the DIDFA
Currently under the ODBA and the DIDFA, rebates, except for prompt payment discounts and professional allowances, are prohibited. The proposed changes clarify exclusions from the definition of rebate and provide that a rebate does not include the value of a benefit that is provided in accordance with ordinary commercial terms and meets all of the following conditions:
- It is provided in the ordinary course of business in the supply chain system of listed drug products that are interchangeable under the DIDFA.
- The value of the benefit is set out in a written agreement.
- The benefit relates to a prompt payment discount, a volume discount or a distribution service fee.
A rebate also does not include the value of a benefit provided in accordance with ordinary commercial terms with respect to a product that is not interchangeable, as long as those commercial terms are a prompt payment discount.
5. Changes to Private Label Drug Status
"Private label" products will no longer be listed on the Formulary under the ODBA and will not be designated as interchangeable under the DIDFA. In essence, this means that private label drug products will not be reimbursed by the government under the public health plans.
A copy of the proposed amendments to the regulations can be found at: http://www.health.gov.on.ca/english/public/legislation/drugs/regulation_935.pdf.
A copy of the current ODBA and DIDFA legislation and regulations can be found at http://www.e-laws.gov.on.ca/navigation?file=home&lang=en.
The above briefly highlights the proposed changes. For a complete summary of the proposed regulations and potential impact on your business, please contact one of the authors.