[Ip-health] Op-ed on Canada's Access to Medicines Regime

[Laura Esmail]

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Does Canada have the guts to honour its drug pledge to the world's poor?

JILLIAN CLARE COHEN AND LAURA ESMAIL
January 30, 2007

Special to Globe and Mail Update

Nearly two years have passed since Canada's Access to Medicines Regime
came into force and yet not a single pill has crossed the border. This
legislation, originally known as the Jean Chr=E9tien Pledge to Africa, was
designed to allow generic pharmaceutical companies to produce and export
affordable drugs that are under patent to developing countries facing
public health emergencies. This week, the federal government closes the
public consultation stage of its promised two-year review of the
legislation. Will Canada have the guts to fulfill its promise to the
world's poor?

Much public consultation and scrutiny have already taken place. Yet, the
legislation is seemingly unable to meet its humanitarian goals, and is
divorced from global realities.

One of the most glaring deficiencies in the legislation's current
crafting is that it does not reflect global pharmaceutical market
conditions. The vast majority of cheap, generic drugs are being exported
to least developing countries from sourcing countries such as India,
China and Brazil. From a price point, Canadian producers are unable to
compete, given that input costs are significantly lower in these
countries. The legislation should take into account Canada's comparative
advantage in terms of pharmaceutical production capabilities. It ought
to focus more strategically on drug products that these sourcing
countries are not able to produce, given existing intellectual property
requirements and drugs that are in the pipeline.

The list of medicines for which this legislation can be used fails
developing countries simply because many are already sourcing these
products from elsewhere. The list does not include many vital drugs,
including anti-malarial and antiretroviral drug therapies.
Non-communicable diseases are responsible for more than one-third of all
deaths in low-income countries, yet many of the drugs listed for these
diseases are already available from Indian generic manufacturers.

Administratively, it is a nightmare. It wrongly assumes that developing
countries have the requisite knowledge and capacity to make use of the
regime and are also prepared to break existing contracts for cheap
generic drugs. To make matters worse, countries must proceed through
this complex, administrative process for every shipment of every drug.
These and other deficiencies could have been easily dealt with earlier
if there had been sufficient input from developing countries, the
intended beneficiaries of this legislation in the first place. There
have been attempts to use the legislation, the most promising example
being 'M=E9decins sans Fronti=E8res' drug order through Apotex. At MSF's
request, Apotex has produced 150,000 tablets of a fixed-dose combination
antiretroviral drug and received Health Canada's approval in July. But
the process stalled because Apotex has yet to receive either a voluntary
licence from the patent holders or a compulsory licence from government.

A clear disincentive for generic companies is the fact that they need to
undertake voluntary licence negotiations with potentially multiple
patent holders pursuant to this law. Not only is this a lengthy and
expensive process, but there is no time limit given to these
requirements. And even if a voluntary licence is not granted, it is
unlikely that generic companies will pursue a compulsory licence given
that the costs (primarily legal) would be high with little economic
benefit in return.

One of the primary sources of tension inherent in this legislation is
the need to ensure that both humanitarian and commercial interests are
addressed. In its current form, the legislation fails to provide
satisfactory inclusions on both accounts. Provisions demanding explicit
recognition of non-commercial objectives expose generic manufacturers to
much litigation, further dissuading them from engaging in this
humanitarian initiative. These provisions must be removed.

It is nonsensical to demand that the generic industry become a
non-profit agency when applying this legislation. Generic producers are
in the business of making money; the government ought to be crafting
commercial incentives so these companies will want to compete for
business pursuant to this law. Philanthropy, while morally appealing,
will not make this legislation work and help get drugs to those who
desperately need them.

International development demands policy that is sensitive to individual
country needs. Yet, this legislation ignores that by imposing a "one
size fits all" approach to medicines through its limited list of drugs.

Perhaps if there had been sufficient counsel from developing countries
themselves and less catering to political lobbies, we could have enacted
legislation that is designed to work, not simply offer global showmanship.

The Harper government has an opportunity to make this legislation work
and save us from international shame. Let's hope its efforts are authentic.

Jillian Clare Cohen is an assistant professor in the Leslie Dan Faculty
of Pharmacy at the University of Toronto and director of the Comparative
Program on Health and Society at the Munk Centre for International
Studies. Laura Esmail is a doctoral candidate in the Leslie Dan Faculty
of Pharmacy, University of Toronto.

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