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| Re : Bill 102 August 2006Helen Stevenson Executive Lead, Drug System Secretariat Ontario Ministry of Health and Long-Term Care 11th Floor, Hepburn Block 80 Grosvenor Street Toronto, ON, M7A 1R3 FAX: (416) 327 4044 E-mail: helen.stevenson@moh.gov.on.ca Dear Ms. Stevenson, Re : Bill 102 The Centre for ADD Advocacy, Canada (CADDAC) is a national Canadian alliance of organizations and individuals. CADDAC is striving to enable all Canadians affected by ADD/ADHD through advocacy and education. CADDAC takes a leadership role to educate people on how to advocate for themselves, their children and their schools. It also runs workshops, advocates on behalf of all Canadians affected by ADD/ADHD and provides ongoing advocacy training. Our goals are:
We appreciate the opportunity to comment on the proposed regulations related to Bill 102. However, we are concerned that the regulations themselves do not include enough detail to clearly show how the new initiatives will actually function in daily practice. It appears that in actual practice, like Health Canada, the day to day operations will be governed by policies, frameworks and guidelines which may be changed on an on-going basis without having to open up the Acts or the Regulations. Although CADDAC has no specific objection to this approach, it is important that these policies, frameworks and guidelines be publicly available and that public input is considered when putting them in place. In addition, it is not enough to simply consult with sponsors (e.g., pharmaceutical companies). The actual customers of these medications must also be included. When we say customers, we are referring to patients, their care-givers and families. These are the individuals who ultimately pay for and consume drug technologies. Due to the lack of specifics in the Regulations, it has not been possible for us to provide specific comments at this time. However, we will be addressing specific concerns related to the management of ADD/ADHD to ODB directly in the near future. General concerns are outlined here. Consultation As a general principle for ODB, customers (patients, their care-givers and families) should be proactively consulted on the availability and delivery of drug technologies. It is unclear to CADDAC at this time how this will be facilitated by ODB Conditional Listing It appears that your plan is to negotiate with individual sponsors (e.g., pharmaceutical companies) regarding conditional listing of specific drugs. This is similar to the offset process previously implemented by ODB. The problem with a process that focuses on pharmaceutical companies is that they will be negotiating a deal that supports the pharmaceutical company's marketing strategy for that particular year. One would not expect a pharmaceutical company to consider the long-term needs of individual patients in their marketing strategy. It is CADDAC's opinion that it is unacceptable for only government and pharmaceutical company objectives to be considered when determining conditional listing status for a particular drug. CADDAC's recommendation is for ODB to include patients in the negotiations for conditional listing status. The relevant patient population, through their representatives, would then be able to ensure patient's needs are considered in the listing decision. In this way, all three stakeholders - the taxpayer, the supplier and the customer - will be included in the process of determining conditional listing and the outcome of conditional listing. Citizen's Council CADDAC is concerned that the 'citizens' will be nothing more than political appointees being rewarded for their support of the government of the day. It is difficult to envision how random 'citizens' could represent various patient needs by therapeutic area. Physicians are not expected to do this. Why would lay people be expected to accomplish something physicians are not expected to do? Specialists are consulted on drug technologies in their area of expertise. Why not also do this with patients? CADDAC's recommendation is for there to be a registry of citizen's set up by therapeutic area so that when an individual drug is being discussed, a citizen educated in the needs of that particular area may be called upon. In this way, a cancer patient would not consider a new lipid lowering technology and a heart attack survivor would not be asked for their opinion on a new arthritis strategy. Substitution CADDAC's position is if any type of therapeutic or category substitution is to take place, the health care professional charged with making the substitution decision can have no financial incentive in the outcome of the decision. Therefore, in addition to prescribers, only pharmacists working in a health network or similar practice setting should be making substitution decisions. Timely Access CADDAC would like ODB to put processes in place to ensure timely access to new technologies. Health Canada has made significant progress in this regard in the last 18 months and ODB needs to follow their example. It is unclear how the new legislation will accomplish this goal. Additional communication in this regard would be appreciated. Executive Director Although CADDAC has no objection to the position of Executive Director as a strategy for improving the overall delivery of drug technologies to patients, it is critical that the right person fulfil this role. It is unacceptable to CADDAC for the Executive Director to be anything other than a health care professional. CADDAC strongly objects to this role being given to an economist, accountant, lawyer, PhD or some other non-health care professional. More specifically, the individual should have experience in a direct patient care setting whether a community or hospital pharmacy or in a medical practice setting. The Executive Director must be a physician, nurse or pharmacist. Reporting Transparency Individual listing decisions should be publicly available and include the reasons for the decisions along with any dissention. This should be available on the ODB website and not solely through Freedom of Information. Taxpayers, health care providers and customers should have easy access to this information. Implementation Date October 1st is less than six weeks away. CADDAC is concerned that ODB will not be ready to implement new systems in that timeframe. If the initial launch is not successful, it will be difficult to maintain the support of your stakeholders. Consideration should be given to postponing the initiation of the changes until systems are in place to ensure success. Rebates There should be no monetary incentive for a pharmacy or pharmacist to purchase, stock, recommend or dispense any particular drug, brand of drug or generic product. The Ontario government should find alternate means of supporting the role of the pharmacist in the delivery of healthcare in Ontario. Options include increasing the dispensing fee, paying pharmacists for cognitive services and funding pharmacists to work in group medical practices (family physician and specialist offices). Suppliers should not pay pharmacists to provide health care services. This is even more important in a system where pharmacists may have prescribing authority and or the ability to therapeutically substitute one drug for another. It is hoped these comments will be used to enhance the proposal and CADDAC looks forward to working with ODB directly in the future. Sincerely, Dianne Azzarello, BSc Phm Director Centre for ADD/ADHD Advocacy Canada cc: Mr. Brent Fraser |