Canada Should Pass Bill That Would Expedite Export of Low-Cost Drugs for HIV

"For many years, countries such as Canada have avoided the uncomfortable truth that millions are dying in the developing world due partly to legal barriers that render access to medicines unaffordable," Michael Geist, chair of Internet and E-commerce law at the University of Ottawa, writes in a Toronto Star opinion piece in response to a recently introduced bill that would reform Canada's Access to Medicines Regime by expediting the process of exporting generic drugs for diseases such as HIV to developing countries. According to Geist, Canada "became an early adopter" of a 2003 World Trade Organization agreement aimed at easing the export of drugs. However, "[s]everal years later, most agree the policy has been a near-total failure," he adds. According to Geist, the law "has only been used once, and the company involved in the process found it so burdensome that it has vowed not to repeat it."

The new bill, introduced by Sen. Yoine Goldstein, "includes important reforms to" Canada's Patent Act, Geist writes, adding that it "would not remove all barriers, but it would help to streamline the process of obtaining the necessary approvals." He adds, "Most importantly, it would establish a 'one-license solution' to enable generic pharmaceutical manufacturers to send shipments of the same medication to multiple countries without needing new approvals for each shipment." In addition, current law allows only governments to "buy medicines on behalf of citizens," Geist writes, concluding that the bill "would make it easier for the many nongovernmental organizations focused on access to medicines to buy and distribute generic medications" (Geist, Toronto Star, 4/13).

Drug Companies "Block" Cheap Medicine

Their actions cost EU healthcare providers 3bn euros ($3.9bn; £2.5bn) in savings between 2000 and 2007, it said. It added that drug firms used legal action and multiple patents to stop rivals getting to market.Drug firms said the "perfectly lawful" measures were justified to protect investment in research and development.

Market access

Generic drug companies - which sell cheaper versions of drugs once the patent has expired - have long complained that it is difficult to get their drugs to market in Europe. The Commission said that innovators filed multiple applications to stop generic drugs getting to market - in one case, there were 1,300 patents for a single drug.

The report found that owners of original drugs often intervened in national approval procedures for generic medicines. There were nearly 700 cases of reported patent litigation and more than 200 settlements between brand name drug companies and generic companies. More than 10% of these settlements limited the entry of the generic drug to the market.

Fine threat

"Market entry of generic companies and the development of new and more affordable medicines is sometimes blocked or delayed, at significant cost to healthcare systems, consumers and taxpayers," said Competition Commissioner Neelie Kroes. "It is still early days but the Commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached," she added.The Commission could impose large fines on drug companies if they have engaged in unfair practices. In 2005, AstraZeneca was fined 60m euros for blocking cheaper rivals to Losec, its heartburn and ulcer pill.

Pressure mounts

Drug firms use "perfectly lawful practices - such as patent portfolios, patent litigation and the release of improved medicines," the European Federation of Pharmaceutical Industries and Associations (EFPIA) said.

"These [practices] are essential for innovators to protect their huge investment in R&D [research and development]," it said, adding that the 17% of turnover industry spent on R&D exceeds any other sector in Europe. The EFPIA - which said the Commission's report missed the opportunity to tackle the real issues facing the industry - called for a more competitive market for generic drugs, pointing out that Europeans pay more for generic drugs than US citizens.

In response to claims that the delayed or blocked sale of generic drugs was pushing up healthcare costs, the EFPIA said: "A single member state, the Netherlands, achieved greater savings - up to 400m euros - in one year, on only 33 medicines, simply by promoting greater price competition between generics."

The Commission report increases the pressure on the global pharmaceuticals industry.

Barack Obama, the US President-elect, is also expected to try to cut costs as part of the reform of healthcare coverage in the US.

Generics Really Do Measure up to Brand Name Drugs

Brand-name drugs for treating cardiovascular disease don't appear to be clinically superior to generic versions, say U.S. researchers who reviewed studies comparing the drugs.

Some doctors and patients have expressed concerns that the drugs may not be equivalent in their effects, although generic drugs are chemically equivalent in terms of active ingredients, the study's authors said.

In Wednesday's issue of the Journal of the American Medical Association, Dr. Aaron Kesselheim of Brigham and Women's Hospital and Harvard Medical School in Boston and his colleagues combined the results of 30 studies done since 1984 that compared nine subclasses of cardiovascular medications, 81 per cent of which were randomized controlled trials.

"The studies in our sample concluded that generic and brand-name cardiovascular drugs are similar in nearly all clinical outcomes," the researchers concluded.

Brand-name prescription drugs are sold at high prices after approval by the U.S. Food and Drug Administration and while under patent protection, the study's authors said. Brand-name cardiovascular drugs may cost as much as a few dollars per pill while generics may be as little as a few cents a pill, Kesselheim added.

"If a patient is prescribed a generic drug because that's what's appropriate for their condition, then they should feel confident taking that drug. And physicians themselves should also feel confident prescribing generic drugs where appropriate," Kesselheim said in a telephone interview.

The review of randomized clinical trials found clinical equivalence in:

* 7 of 7 trials for beta-blockers.
* 10 of 11 trials of diuretics.
* 5 of 7 trials for calcium-channel blockers.
* 3 of 3 trials for antiplatelet agents.
* 2 of 2 trials of statins.
* A single trial for angiotensin-converting enzyme or ACE inhibitors.
* A single trial for alpha-blockers.

Cost questions

Of 43 editorials and commentaries reviewed, 23 or 53 per cent expressed a negative view of the interchangeability of generic drugs compared with 12 (28 per cent) that encouraged substitution of generic drugs, with the remaining eight not reaching a conclusion, Kesselheim and his colleagues said.

As for why, commentaries may be more likely to highlight doctors' concerns based on anecdotal experience, and the conclusion of the editorial writers could be skewed by financial relationships, the team said in noting that nearly half of the editorials and commentaries did not identify sources of funding.

Generic medications account for 65 per cent of all prescriptions dispensed in the U.S. and less than 21 per cent of money spent on prescriptions, according to IMS Health, a company that tracks prescription drug sales.

"The contention that brand-name medicines drive up the cost of health care is fatally flawed," Ken Johnson, senior vice-president of the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents brand-name drug makers, said in a statement released in response to the study.

"Without today's innovative brand-name drugs to legally copy, there would be no generic drug industry," he said.

The study's authors reported no financial disclosures.
With files from Reuters