Canada to lift patents on ARVs

Indications are that it will still be a good few months before Canada introduces legislation allowing it’€™s drug manufacturers to export cheaper anti-retrovirals to developing countries, a move that will hopefully stimulate other G7 countries to follow.

The remarkable announcement by Canada that it was willing to issue a compulsory license, lifting the patent protection that covers most anti-retrovirals, followed a proposal by Stephen Lewis, a Canadian who serves as United Nations Secretary-General Koffi Annan’€™s Special Envoy for HIV/AIDS in Africa.

Lewis’€™proposal at the end of September was in response to two significant developments. First, at the end of August the World Trade Organisation agreed to let poor countries import cheap generic copies of patent-protected drugs as long as they could not make them domestically, were not importing them for commercial purposes, and could find a supplier willing to issue a compulsory license to lift the patent protection.

According to Lewis the only things that stood in the way of such as an initiative was a lack of political will and the influence of the big pharmaceutical companies ‘€“ incidentally both significant factors in South Africa.

Second, at the beginning of October Dr Lee Jong-wook, the new head of the World Health Organisation announced that his top priority would be to achieve the ‘€œ3 by 5’€ goal of three million people receiving anti-retroviral treatment by 2005. Lee added that the current HIV/AIDS situation represented a global health emergency, which countries might find useful when justifying the issuing of a compulsory license.

The Canadians were quick to respond to Lewis’€™proposal, announcing at the beginning of October that they would give their support to a plan to alter the country’€™s pharmaceutical drug patent laws to the allow the production and exportation of generic anti-retroviral drugs. Such a move would make Canada the first Group of Seven industrialized country to do so.

The Canadian brand-name drug company lobby group, Research-Based Pharmaceutical Companies, was also quick to react, stating that it would work with lawmakers to draft legislation to make generic ARVs available for export.

‘€œThe country has an opportunity to show international leadership,’€ the group said.

In the most recent development Canada unveiled the bill in parliament, but cautioned that it was not likely to be passed anytime soon.

On Friday (November 7) the Canadian parliament sent the Bill to the relevant committee for hearings. Following these hearings the Bill will be returned with recommendations for amendments for the third and final reading that would enact it into law.

However, Canadian civil society organizations identified some serious flaws in the bill as introduced at the hearings.

The organizations, including the Canadian HIV/AIDS Legal Network, warned that the flaws in Bill C-56, as it is currently drafted would undermine its noble objectives.

Concerns with the bill include the following:

  • Limited list of pharmaceutical products. The bill includes a limited list of pharmaceutical products for which a compulsory license may be obtained. Civil society organisations have objected to the inclusion of this limited list as it would represent a step backward from the World Trade Organisation agreement in which all members endorsed an approach that is not restricted to specific medicines or other products.
  • Denial of benefit to some developing countries that are not WTO members. Organisations said there was no sound basis for excluding non-WTO member countries from the potential benefit   and urged Canada to change this.
  • No provision for NGOs to procure generic medicines. The current bill states that a government of a developing country or an agent of that government could enter into a contract with a Canadian generic manufacturer. Organisations urged Canada to include non-governmental organizations and other private sector entitites providing treatment.
  • Provisions permitting patent-holders to block licences for generic manufacturers. This would give the company holding the Canadian patent on a pharmaceutical product the right to take over contracts negotiated by the generic pharmaceutical manufacturers with developing country governments. This creates an added entitlement for patent-holders: by taking over a contract negotiated by a generic manufacturer, the patentholder can block the generic manufacturer from obtaining any licence at all, whether voluntary or compulsory.

The House of Commons was expect to adjourn until there had been a change in the ruling party’€™s leadership, but the prime minister had already indicated his support of the legislation, indicating that it could be passed as soon as parliament resumed.

Cuurent prime minister Jean Chretien is set to retire and be replaced by Liberal Party leader Paul Martin, who has also added his support.

Jonathan Berger of South African’€™s AIDS Law Project pointed out that the symbolic significance of the Canadian decision could not be ignored.

He said very few developing countries have moved to implement that WTO agreement allowing poorer countries to override patent laws. ‘€œWe don’€™t know whether this is because of fear of trade sanctions’€¦but the bottom line is they haven’€™t acted,’€ said Berger.

He said the main short term significance of the Canada move would be the impetus it would create among other countries to change their existing patent laws.

However, he cautioned that the Canadian legislation still had some potential stumbling blocks.

Berger and other AIDS activists agree that the draft language in the Canadian legislation giving brand-name companies a ‘€œright of first refusal’€ in responding to requests for low cost medicines would undermine the potential public health benefits of the amendment.

‘€œCanada’€™s good intentions are not enough,’€ said Asia Russell of Health GAP. ‘€œGiving brand name companies preferential treatment will discourage generic competition ‘€“ contradicting the intention of the amendment, and transforming an important display of leadership into little more than an empty gesture on the part of an outgoing government.’€

Health GAP also noted that establishing a right of first refusal for brand name companies in Canada would make it easier to establish the same system for other programmes, such as US President George Bush’€™s Emergency Plan for AIDS relief, which is directed by retired drug company CEO Randy Tobias.

‘€œIf a flawed system that decreases instead of increases the chances of generic competition is accepted by Canada, it will likely migrate to the Bush AIDS Plan, keeping pharma happy, but undermining public health and access to medicines for all,’€ said Health GAP.
 Harvey Bale of the International Federation of Pharmaceutical Manufacturers Associations, an international body representing big pharma, said the initiative would erode patent protection and ‘€œwon’€™t solve a thing’€.

e-mail Anso Thom

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    Health-e News is South Africa's dedicated health news service and home to OurHealth citizen journalism. Follow us on Twitter @HealtheNews

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