| Jun 29, 2006

Legalese - March 30, 2006

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Legalese - June 29, 2006 Bill 102 – Changes to the Drug Interchangeability and Dispensing Fee Act & the Ontario Drug Benefit Act

[The following article was originally published in HALCO News, the newsletter of the HIV & AIDS legal clinic (Ontario), a specialty legal clinic in Toronto. Reprinted with permission.]

Bill 102 is the Ontario government’s response to escalating costs for drugs, and complaints about the programs we have to help people access drugs.

The Bill, if passed, would make changes to the Drug Interchangeability and Dispensing Fee Act (DIDFA) and the Ontario Drug Benefit Act (ODBA). Some of the key changes are:

Legalese_06-26A new “Conditional Listing” category will be created for new drugs that have not yet been fully evaluated or processed for formal listing. This will allow patients to access new drugs on a conditional basis without needing to go through individual section 8 applications.A position of “Executive Officer of the Ontario Drug Programs” would be created. The Executive Officer would be a political appointee who would exercise many powers now held by cabinet and the Minister. These include placing drugs on the ODBA formulary (the list of drugs funded for ODSP, OW, Trillium and seniors), removing drugs from the formulary, deciding who will get unlisted drugs (those not listed on the formulary) in special circumstances (the current ODBA Section 8), and designating which drugs are interchangeable.

This could potentially result in decisions being made more quickly. For example, new drugs could be made accessible more quickly and decisions on funding unlisted drugs could be made more quickly. However, there could be questions about the accountability of the Executive Officer – a great deal of authority would be placed in the hands of one unelected official.

The criteria for designating drugs to be interchangeable would be loosened. Currently a pharmacist can dispense a generic drug in place of a name brand drug prescribed by a physician. However, this can only be done if the actual drug and the formulation are the same. Under the new Act, interchangeability would be broadened. For instance the Executive Officer could designate a product to be interchangeable if it contains “the same amounts of the same or similar active ingredients in the same or similar dosage form.” This is intended to lower the cost of drug treatments by allowing more generic drugs to be dispensed. However, this also has the potential to result in serious medical problems when a pharmacist dispenses a drug or formulation different than what the doctor prescribes. Rebates from drug companies to pharmacists will no longer be permitted. Currently, drug producers can give rebates to pharmacies that dispensed their products. This is an incentive for pharmacists to dispense generic drugs which are interchangeable with name brand drugs. This is, again, intended to reduce the cost of drugs funded under the ODBA. Some pharmacists have argued that small independent pharmacies depend on these rebates to stay in business and that without this source of income some pharmacies would close. Although not part of Bill 102, the government has also announced that the mark-up pharmacists can charge on a product will be reduced from 10% to 8 % and capped at $25. This could make it impractical for small independent pharmacists to stock expensive drugs (e.g. anti-retrovirals), again making these drugs less accessible.The current ODBA Section 8, under which unlisted drugs are funded in special circumstances, is replaced by Section 16. The wording of Section 16 is almost identical to Section 8 except that the Executive Officer will now make decisions under the section in place of the Minister who currently has the authority to make these decisions. Also, the new Section 16 states explicitly that decisions made under the section can be made to apply retroactively. This is not included in the current Section 8.

Although not part of Bill 102, the government has announced that the current Drug Quality and Therapeutics Committee will be renamed the “Committee to Evaluate Drugs” and will include 2 patient representatives. This committee would be involved in individual drug funding decisions. The creation of a Citizens’ Council, which would provide recommendations on related policy issues, has also been announced.

Bill 102 has been referred to the Standing Committee on Social Policy and public hearings have been scheduled for May 29 and 30 and June 3, 4 and 5. HALCO will continue to monitor developments in this area.

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