Patient coalition welcomes drug safety measures; progressive, flexible approach benefits patients

The Canadian government has recently introduced a Bill (C-51), which proposes to strengthen existing health regulations in order to better regulate natural health products and improve patient safety.  The following statement of support from Canada’s Best Medicines Coaltion is one of many from patient groups around the country:

New legislation will enable Health Canada to implement more effective ongoing safety monitoring of drugs without unnecessarily restricting patient access, said the Best Medicines Coalition, an organization representing patients across Canada.

Amendments to the Food and Drug Act tabled in the House of Commons today modernize the current system while harmonizing with established practices internationally, allowing strengthening of measures to monitor drug safety issues throughout the product lifecycle and harmonization internationally. This includes from when applications for approval are first filed, as is the case with the current regulatory regime, through the period when drugs are available on the market and the years following. The legislation includes measures to ensure compliance, including some mandatory reporting of adverse events, and enforcement of regulations.

“For patients with serious illnesses, an inflexible ‘one-size-fits-all’ approach to drug licensing as we have had in the past simply does not work,” said Louise Binder, Chair of the Best Medicines Coalition. “Weighing risks and benefits of any drug is complicated and demands a subtle and sophisticated regulatory regime, so a progressive approach with staged licensing makes sense. Safety assessments must take into account the needs of patients with life-threatening illnesses who may need access to new therapies.”

“Some safety issues may not emerge until well after a drug reaches the market, and this intelligence must be captured and incorporated into patient care. Canada has an abysmal record in terms of the reporting and tracking of adverse events for marketed drugs which are now in use, and we are optimistic that this new framework will allow reporting rates to be improved,” Binder added.

The Best Medicines Coalition has been closely involved in the consultative process leading up to the tabling of this legislation. Moving forward, the Best Medicines Coalition will be seeking opportunities to work collaboratively with Health Canada to ensure that patient interests are protected as regulations are developed and through implementation phases. Specifically, wording addressing personal information and Ministerial powers are of concern and warrant careful consideration.

Formed in 2002, the BMC is a national alliance of patient-driven organizations and individuals, representing those living with or affected by chronic disease or illness, who are concerned about drug review reform, treatment access, patient safety and general health policy development.

A Triumph of Astroturf? Regulation of the Canadian natural health products industry.

The use of natural health products such as multi-vitamins, herbs, etc. has increased dramatically in Canada – and many other developed countries – over the past decade.  While some of these products may provide health benefits, the majority of health claims are made with little or no basis in science.

Regardless of whether you believe the health claims, there is no doubt that better regulation of the natural health products industry will help to protect the safety and health of consumers.  The recent dishonest advocacy efforts of a controversial online supplement company should serve as sufficient evidence that better enforcement of existing laws will protect consumers and legitimate companies.

A Triumph of Astroturf?
Although regulated in Canada since 2004, natural health products nevertheless enjoy a hothouse climate of easy licensing, minimal oversight, and toothless enforcement — which [bill] C-51 is designed to improve. Health Canada’s [current] limited enforcement powers have created a wild west landscape in which the good, bad, and ugly parts of the supplement industry have all thrived. Not surprisingly, many — especially the shadiest operations — would like things to stay just as wild as they’ve been.

Amazingly, one supplement company’s sly manipulation of public opinion could accomplish just that.

Like most Canadians, the first things I heard about C-51 were bad. I became aware of Bill C-51 when, largely in advance of mainstream media interest, dozens of “stop C-51” themed common interest group pages suddenly appeared on the social networking website Facebook. With alarming titles like “Stop bill C-51 from banning all natural health products!” these pages promote wildly unlikely claims about C-51, while urgently soliciting people to attend scheduled protest rallies and write letters to their Members of Parliament (MPs).

But who was behind it all? Nothing at StopC51.com disclosed the authors of the site, nor did the site provide a contact address for the site’s administrators. But, it was a pretty thin facade: the 1-888 contact number for StopC51.com rally organizing is actually the phone number for a controversial online supplement company called Truehope Nutritional Support Ltd.

Truehope has long been embroiled in a series of battles with Health Canada regarding their drug “Truehope EMPowerplus,” which is a $70 per bottle mail order multivitamin sold for the treatment of bipolar disorder and “multiple deficiencies in numerous areas of the body including the Central Nervous System.”  Not surprisingly, Health Canada doubted the implausible marketing hype that an overpriced multivitamin was successful in “reducing/eliminating the symptoms of bipolar disorder and other mental illnesses in thousands of individuals.” In any event, Health Canada advisories explained, “It is a drug … which has not been approved for sale in Canada.”

The truth is that:

Under C-51, the existing Natural Health Products Regulations (which came into effect in 2004 after extensive consultation with the natural health products industry) remain the law of the land. Even the standards for compliance action remain the same (a standing risk-based policy that explicitly deemphasizes vitamins, minerals, and homeopathic preparations). C-51 merely increases Health Canada’s ability to deter criminals from ignoring the existing laws.

Fighting neglected tropical diseases should be a priority for the G-8

As leaders of the G-8 met last week in Japan, the worldwide pharmaceutical industry joined the World Health Organization (WHO) and the Drugs for Neglected Diseases initiative (DNDi) in calling on the G-8 to recognize the importance of neglected diseases as a global health threat and a major strain on the economic viability and educational development of communities worldwide.

Dr. Paul Antony, Medical Director of Global Health Progress stated that:

Partnerships supported by the research-based biopharmaceutical companies have provided billions of dollars in medicines, research and development, supplies, distribution networks and other resources to fight neglected diseases such as river blindness, trachoma, and lymphatic filariasis around the world. In the process, we have lowered the cost for effective treatments and made them available to hundreds of millions of people each year. Companies have also made substantial contributions to building health care capacity in developing countries, and are looking to implement more programs to address remaining gaps in care.

However, the continuing threat of these diseases, which affect one in six people worldwide, and the lack of access to existing treatment and preventative measures makes it clear that there is more work to do. Involvement by the global community, particularly the countries of the G-8, is necessary to further efforts aimed at meeting the critical health challenges of the developing world.

http://www.globalhealthprogress.org/media/CommitmentsNeededforFightingNTDs.php

Consumers in Canada spend the same percentage of their income on prescription drugs as in the United States

Despite the significant differences between the Canadian and American healthcare systems, consumers in both countries spend the same percentage of their income on prescription drugs. 

Government policies surrounding the pricing and reimbursement of prescription drugs in Canada do not produce lower costs for Canadians compared to Americans.  Despite major differences between the Canadian and American healthcare systems, the results of a recent study show that consumers in both countries are spending the same percentage of their incomes on prescription drugs.

The price of generic drugs in Canada is more than double U.S. prices for identical drugs, while brand-name drugs are comparatively cheaper.  In currency-equivalent terms, Canadian retail prices for brand-name pharmaceuticals decreased slightly between 2003 and 2007.  In the same time frame, generic drug prices in Canada increased by 34% compared to U.S. prices.

The authors of the study state that Canadian government policies insulate generic drug companies and pharmacy retailers from normal market forces that would put downward pressure on prices for generic drugs. A relatively freer market in the United States produces lower prices for generic drugs to encourage consumers to substitute these generics in place of brand-name drugs.

Various policies of federal, territorial, and provincial governments in Canada are designed to force patients to use generic versions of drugs. The cumulative effect of these public policies has been to inhibit the downward pressure on the retail prices of generic drug products that would occur under normal market conditions.

The principal author of the study calculates that in 2007 alone, Canadian policies aimed at regulating prescription drugs cost consumers C$2.9-C$7.5 billion in unnecessary spending, “due to a combination of inflated prices for generic drugs and inefficient substitution of medicines.”

Read the original newsletter at www.worldhealthadvocacy.com.