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Canada’s Federal Court says no price-control measures for generic drug companies

BY Michael Johnsen

Canada’s Federal Court ruled recently that the country’s Patented Medicine Prices Review Board — a federal tribunal that regulates pricing on branded medicines — could not extend price-control measures to cover generic drug companies, according to published reports.

The ruling covered two cases involving generic drug makers Ratiopharm (now Teva Canada) and Sandoz.

“The decision means that generic drug makers who do not hold patents themselves and do not exercise monopoly power need not file price information with the board,” Gavin MacKenzie of Davis LLP’s Toronto office, who represented Ratiopharm and Sandoz, told Canada’s National Post.

In the case of Ratiopharm, the court reversed a $65 million decision.

The PMPRB has been in operation since 1987 to ensure that drug manufacturers do not charge exuberant prices for medicines under patent protection and without market competition. In 2008, according to MacKenzie, PMPRB extended those price controls to authorized generics, arguing that because the medicines were still under patent protection that defined the generic manufacturers as “patentees.”

In separate cases, Ratiopharm and Sandoz challenged PMPRB’s classification of “patentees,” arguing that the tribunal had no jurisdiction over generic companies and charging that the board’s price-control powers may be unconstitutional.

“The board should confine its role to reviewing prices charged by patent holders, who benefit from a time-limited monopoly, to determine whether those prices are excessive,” wrote Federal Court Judge James O’Reilly in his ruling. He noted that under the terms of the Patent Act, the act is “not aimed at protecting consumers from high drug prices, generally, and the board’s role certainly does not extend that far. … Generally speaking, generic companies either help create or join a competitive marketplace, which helps keep the costs of patented medicines down,” he wrote. They “do not generally hold monopolies and, in fact, do not normally operate in a market where any monopoly exists.”

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Expanding Rx’s vaccination role

BY Richard Monks

As patients across North America continue to turn to their neighborhood pharmacy for vaccinations, state and provincial governments in the United States and Canada are widening the range of immunizations that can be administered by a pharmacist.

(For the full report, including charts, click here.)

“There’s been a recognition that pharmacists play a valuable role in maintaining patients’ health,” American Pharmacists Association chief strategy officer Mitchel Rothholz said. “Public health officials around the country have come to see providing vaccines as a critical component of that role.”

While all 50 states allow pharmacists with immunization training and certification to administer some vaccines, a handful continue to restrict pharmacists to providing just flu shots and a limited number of other immunizations.

All told, 43 states, the District of Columbia and Puerto Rico allow pharmacists with an existing prescriber protocol to administer any vaccine approved by the Centers for Disease Control and Prevention. Of these jurisdictions, however, 18 mandate that a patient have a prescription. In some cases that requirement is limited only to patients younger than 18 years old.

In Canada, six of the country’s 13 provinces and territories allow pharmacists to administer flu vaccines with some jurisdictions also permitting them to provide other immunizations.

Meanwhile, regulators across the United States continue to loosen restrictions on pharmacist-administered vaccinations.

In Louisiana, for instance, a bill introduced last month would let pharmacists administer all immunizations and vaccines without a prescription to patients older than 17 years.

That proposal comes on the heels of several other changes to state laws over the past year that have expanded pharmacists’ role in immunizations.

Among those moves, the one that has impacted the greatest number of patients has been California’s expansion of pharmacists’ scope of practice. The law, which went into effect in October, makes pharmacists in the state a more central part of a patient’s healthcare team, and authorizes them to administer drugs and routine vaccinations.

That same month also saw North Carolina begin to let pharmacists vaccinate against pneumonia, shingles, hepatitis B, meningitis and tetanus. Previously, they were only authorized to administer flu vaccines.

“States are making the right decisions,” National Association of Chain Drug Stores VP of media relations Chrissy Kopple said. “We anticipate that will continue to be the case.”

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Officials: Immunization rates ‘woefully low’

BY Richard Monks

With public health officials calling the number of people receiving crucial immunizations woefully low, physicians and pharmacists across North America are working to get more people vaccinated.

“Because many vaccine-preventable diseases are not common in the United States, often people do not see the devastation it can cause until there is an outbreak,” said Karen Staniforth, group VP pharmacy initiatives and clinical services at Rite Aid. “It is important that we continue to protect our communities with vaccines because outbreaks of vaccine-preventable diseases can and do still occur in this country.”

According to researchers, the country’s declining vaccination rates are having the greatest impact on adults. A study published earlier this year in the journal Annals of Internal Medicine found that an average of 30,000 people in the United States die every year from vaccine-preventable diseases — mostly influenza — with more than 95% of these fatalities occurring in adults.

Researchers estimated that only 62% of people ages 65 years and older receive a pneumococcal vaccine, and just 65% get an influenza vaccine. Only 16% of those older than 60 years receive a herpes zoster vaccine, and just 20% of high-risk adults between 19 years and 64 years get a pneumococcal vaccine.

Since the start of the year, the impact of not enough people getting vaccinated has become front-page news in some areas of the country where sharp spikes in the number of cases of measles and pertussis are being reported. Pharmacies across the country have responded to these outbreaks by expanding the number of stores offering vaccines for these diseases and extending the hours during which they administer the immunizations.

Walgreens divisional VP of immunizations Catherine MacPherson said that giving patients greater access and availability has led to nearly a third of the vaccinations in its pharmacies being administered in the evening, on weekends and on holidays.

“We’ve demonstrated through our flu shot program and other immunization services the ability to have an impact on immunization rates as a key driver to helping improve population health in the communities we serve,” she said.

Immunizers say the key to increasing vaccination rates is driving home the message that vaccines provide a safe and inexpensive way to help patients stay healthy.

“There is a lot of confusion and misinformation about vaccinations in the marketplace,” CVS Caremark VP of pharmacy affairs Papatya Tankut said. “It is important that healthcare providers and practitioners, as well as such agencies as the CDC, continue to communicate publicly with a consistent message about the importance and safety of getting vaccinated.”

Advocates of pharmacist-administered vaccinations say that as the country’s healthcare system continues to evolve, pharmacists’ ability to provide vaccinations fits well with their expanding role in managing patients’ health.

“There is a growing recognition in the healthcare community that pharmacists have a valuable role to play in helping the nation achieve its goals in this area,” American Pharmacists Association chief strategy officer Mitchel Rothholz said. “As the healthcare system moves more toward a team-based model, pharmacist-administered vaccines make more sense.”

While much of the resistance to pharmacists administering a wide range of vaccines has eroded, some in the medical community continue to call for restrictions. In Pennsylvania, which last year lagged behind the national median for immunizations of school-age children, the Pennsylvania chapter of the American Academy of Pediatrics, the Pennsylvania Medical Society and the Pennsylvania Academy of Family Physicians have criticized a recent legislative proposal to lower the age at which pharmacists can provide immunizations. The groups say that doctors are best qualified to deal with a negative drug reaction, should one occur.

Proponents of expanding the scope of pharmacist-administered vaccines, however, say they are confident that such opposition will disappear as more evidence emerges about the impact pharmacists can have on immunization rates and public health.

“The perception of the role of pharmacists has improved over the past several years,” Rothholz said. “As there is more documentation of what pharmacists can do in this area, any remaining barriers to pharmacies providing vaccinations will disappear.”

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