Wednesday, December 5, 2012

A missed opportunity to get tough on substandard drugs

All but seven members of the Conservative caucus voted last Wednesday night against Bill C-398 — Quebec NDP MP Hélène Laverdière’s private member’s bill that aimed to correct Canada’s flawed Access to Medicines Regime (CAMR) — sending it to defeat.

Astute observers recognize that, while CAMR 2.0 was an improvement over its predecessor (a similar draft, Bill C-393, passed the House in March 2011 but died on the Senate’s order paper before Parliament was dissolved for the 2011 federal election), it was far from perfect. Yet activists have cried foul, accusing the government of obstreperous cruelty. The reality is more complex.

Canadian generic drug manufacturers face a considerable competitive disadvantage when it comes to the cost of manufacturing medicines. A highly-competitive international market exists for the supply of cheap, generic drugs from developing countries like India, China, Bangladesh and Sudan.

Incentives, like the proposed “one-license solution,” might have invited greater economies of scale and lower production costs, but this wouldn’t necessarily have made Canadian companies more competitive than their rivals — a legitimate concern when contemplating adjustments to the patent protections enjoyed by our brand-name pharmaceutical companies.

Putting these qualifiers aside, let’s say that Bill C-398 would have provided developing countries with more high-quality, lifesaving, Canadian-manufactured generic drugs. Most parties will agree this is good.

But one argument has been absent from this debate: By blocking the legislation, the Conservatives missed an opportunity to promote their “tough on crime” agenda.

Let me explain: I spent much of the past several months tracking down fake and substandard medicines in East Africa and Southeast Asia. Some of the drugs that infiltrate porous borders in these institutionally-weak and poorly-regulated markets are bad by most objective standards; others may only have become bad due to poor environmental storage conditions and practices. Where the former are being produced by unsophisticated, opportunistic hacks, transnational organized criminals increasingly are entering this dangerous space.

In South Sudan, for example, where health systems are extraordinarily fragile, a quick jaunt through any market where drugs are sold reveals the ubiquitous presence of Coartem, the artemisinin-based combination treatment for the uncomplicated strains of malaria found throughout large swathes of the African and Asian sub-continents. Coartem is supplied without profit by Novartis, the Swiss-based pharmaceutical giant — a similar move, one presumes, to the generous donations our own brand-name pharmaceutical companies are in the habit of making.

There’s just one problem: These medicines, intended for public health facilities where drugs and services should be free, are almost always stolen from their intended recipients and diverted to private stores, where they are then sold at marked-up rates most South Sudanese struggle to afford. Companies like Novartis owe no obligation to guarantee their donations are distributed into the hands of their presumed beneficiaries once the goods are transferred to relevant authorities. Yet the benevolent impact of their largesse is being lost.

Of course, there was no suggestion that Bill C-398’s purpose was to obviate this particular concern. But even where access to medicines is a lesser problem, there is a notable absence of high-quality generic drugs, something that Canadian manufacturers may have been able to rectify with improved incentives and less red tape.

Yes, despite the undeserved bad rap that all developing country-manufactured generics are fake, falsified, or substandard, it certainly is possible to purchase high-quality generic medicines. But the often-higher manufacturing standards Canadian pharmaceuticals are held to means there should be substantial appetite for our drugs, and more confidence in the authenticity of our products. Furthermore, the availability and supply of these superior medicines could actually help crowd out the market for poorer-quality substitutes.

Having established a net-benefit through the promotion of increased medicines-access and pharmacovigilance, it becomes difficult to rationalize the Conservative opposition to Bill C-398’s proposed legislation.

This bill wasn’t the fix-all promised. But, in fighting it, the Conservatives have unequivocally said “no” to reforms that wouldn’t have cost taxpayers a dime; may have improved the international competitiveness of our generic manufacturers; could have increased poor countries’ access to our quality, lifesaving medicines; and might have put a dent in the market for dangerous alternatives. Despite the “ifs,” this still was bad politics.

Enayut, 23 at the time of the shooting, joined the Afghan army in 2006. An expert in disarming bombs, he had a history of going AWOL and receiving no punishment for it. U.S. investigators found that he had slipped away for an unauthorized visit to Pakistan just weeks before the attack.

Investigators were unable to pin down identifying information about the other shooter, although it appeared he also was a soldier and was probably a member of Enayut’s unit, the 4th Battalion, 1st Brigade, 205th Corps. LeVan said both wore Afghan army uniforms in the attack.

In a two-sentence statement the next day, the U.S.-led military command in Kabul said two service members had been killed in an “insurgent attack.” A day later, in identifying Lawrence and Russell as the casualties, the Pentagon reported that “enemy forces” killed them.

The Army’s investigation records show that U.S. officials in Afghanistan were told immediately after the assault that it was perpetrated by one or more Afghan soldiers — not insurgents.

“Yes, we know the shooter,” the Afghan army liaison officer told Lt. Col. John Cook, the commander of Lawrence’s and Russell’s unit, after being summoned back to the compound just moments after the killings. The Afghan officer named Enayut without hesitation.

Asked why its Oct. 9 report was never corrected, the international military command in Kabul said it knew that at least one of the shooters was wearing an Afghan army uniform, “but as that information was unconfirmed, a correction to the original (press) release was not appropriate.”

In April the AP was alerted to the attack’s true circumstances by an American soldier who knew the real story. The U.S. military in Kabul acknowledged to the AP in May that it had added the incident to its 2011 list of insider attacks. But it refused to provide any details of what happened.

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