Review and approval of new drugs takes significantly longer in Canada compared to the United States. A new study published in the Annals of Pharmacotherapy compares new drug approval times in Canada and the United States and examines whether faster, more efficient reviews have an impact on drug safety.

In order to boost the competitiveness of the European-based pharmaceutical industry “in line with the European Union’s health objectives”, the European commission announced plans that include:

• Examining the scope “for improving delays generated by pricing and reimbursement decisions”
• “Improving patient information, strengthening the role of patients in public health decision-making”
• ”Establishing a level playing field on intellectual property protection and providing support to new Member States to implement the legislative framework”

Before a new drug is approved for use by patients, it must undergo rigorous testing and then be reviewed by regulatory agencies (Health Canada). In Canada, the review process for new drugs is much longer than in other developed countries. The result is that Canadian patients wait significantly longer than patients in other countries for access to new medicines.

During the past decade, the evolution of pharmaceutical innovation has resulted in the development of a number of treatments for depression. A class of drugs, known as selective serotonin reuptake inhibitors (SSRIs), have become the dominant depression treatment. Thanks to incremental advancements in pharmaceutical innovation, a number of drugs within this therapeutic class are available, each with distinct properties.

Major advances in drug therapy and patient care often come from incremental improvements - the development of new, enhanced agents within existing drug classes. Having access to a variety of options within a therapeutic class of medicines is particularly important for older patients.

Elderly patients require individually tailored care because of the complex and various nature of health care as we age. These variations include the presence of multiple chronic diseases, and the physiological changes that accompany aging. The evolution of drug therapies through incremental innovation allows physicians to treat patients with more than one condition by choosing from a variety of medications within a therapeutic class to avoid potentially dangerous drug-to-drug interactions or drug-to-disease interactions.

Because Canadian pharmaceutical production represents less than 5 percent of the American pharmaceutical market and Canadian price controls apply only to drugs manufactured for Canadian consumption, re-importing drugs from Canada will not meet the needs of uninsured Americans. In fact, far from meeting the needs of American consumers, the growth of unaccredited internet mail-order pharmacies in Canada is likely to create shortages for Canadian patients and force Canadian regulators to act to curtail mail order drug sales to the U.S.

Nearly 8 million Canadians depend on provincial drug benefit programs for drug coverage. In 1999 this included 3.2 million seniors, 3.2 million people with low incomes, and 1.5 million others. An examination of provincial drug plans shows that there is significant disparity among the provinces in terms of products that are approved for reimbursement. In fact, as of January 15, 1999, only 18 of 148 new drug products approved for use by health Canada were reimbursed by all provinces. The percentage of new drugs reimbursed by provinces range from a high of 83 percent in Quebec to less than 50% in Ontario, Prince Edward Island, New Brunswick, and Newfoundland.

Patients respond differently to medications, therefore choices among drug treatments are important because physicians can determine what treatments are best for individual patients. Older patients, in particular, may react differently to medications because of frailty, differences in organ function or the co-existence of a number of medical conditions. Product alternatives allow physicians to tailor treatment to individual patient needs.

Nearly half of all Medicaid expenditure on prescription drugs is for Medicaid beneficiaries who are also eligible for Medicare (dual beneficiaries). A Commonwealth Fund study estimates that dual beneficiaries accounted for $16 billion or nearly half of the estimated $ 33 billion in Medicaid spending on prescription drugs in 2002. The state share of drug spending on dual eligible beneficiaries is estimated to be $7 billion.