Thank you, Madam Chair and honourable members of the committee. I represent the Intellectual Property Institute of Canada, or IPIC, as a past board member and a past chair of its international trade policy committee.
For those who don't know, IPIC is the professional association of patent agents, trademark agents and lawyers practising in all areas of intellectual property law. Our membership totals over 1,800 individuals in Canada, consisting of practitioners in law firms and agencies of all sizes, including sole practitioners, in-house corporate IP professionals, government personnel and academics. Our members' clients include virtually all Canadian businesses, universities and other institutions that have an interest in IP in Canada or elsewhere, as well as foreign companies that hold IP rights in Canada.
My comments today will focus on Canada's position with respect to the WTO TRIPS waiver.
The purpose of the waiver is to remove IP barriers that prevent WTO members from manufacturing and accessing COVID-19 medical products. A primary goal is to get as many vaccine doses as possible into the arms of the world's 7.8 billion people.
My organization, IPIC, is not here to take a position on whether a TRIPS waiver or any other IP solution will enhance vaccine access. Rather, we are here to provide necessary information about the IP rights framework and Canada's role within it. Our hope is to assist this committee to make recommendations that appropriately balance effective IP protection with the imperative of access to essential medical products. I will make three principal points.
First, the TRIPS waiver is not about enhancing domestic biomanufacturing or Canadian vaccine access. It is about empowering less-developed countries.
Second, TRIPS was designed to provide certain flexibilities to address national health emergencies. The sensibility of a waiver, or any TRIPS-based solution, depends on what needs are unaddressed by those flexibilities.
Third, Canada's experience shows that the effectiveness of a TRIPS solution requires careful consideration and implementation.
My first point is that this committee should not view the proposed TRIPS waiver as being about enhancing Canadian manufacturing or access to COVID-19 vaccines. Removing TRIPS obligations would empower TRIPS members to suspend patent and other IP rights without violating TRIPS. For some countries, such as South Africa or India, provided other important barriers already mentioned are removed, this waiver may clear a path to enhanced COVID-19 vaccine access, both domestically and for export.
This is not so for Canada. Canada's most significant trade agreements over the last 30 years have included IP commitments over and above TRIPS. If TRIPS obligations were suspended, Canada would continue to be subject to such commitments in the Canada-U.S.-Mexico agreement that replaced NAFTA, the trans-Pacific partnership and CETA. These additional barriers mean that Canada would need to negotiate with the U.S., Mexico, the EU and the CPTPP member countries in order to give domestic effect to a TRIPS waiver in those agreements in Canada. After that, domestic amendments would be required to suspend domestic IP provisions to facilitate any extraordinary measure facilitated by the TRIPS waiver.
It is unlikely that all this would be accomplished in a time frame that would be meaningful for enabling Canadian vaccine access, if at all. Canada benefits from near- and medium-term vaccine commitments, and it is unlikely to be capable of large-scale biomanufacturing for export any time soon.
My second point is that the sensibility of a waiver, or any TRIPS-based solution, depends on what needs are unaddressed by the current TRIPS flexibilities for addressing public health. COVID-19 is not the first international health crisis that has led to the rethinking of international IP rules. In fact, the international consensus on IP rules embodied in TRIPS was forged in the fire of the AIDS crisis.
The TRIPS agreement, which was signed in 1994, harmonized a minimum standard of 20 years of patent protection for pharmaceutical inventions, but the agreement also created certain flexibilities. Article 8 of TRIPS authorizes members to adopt measures necessary to protect public health and nutrition, provided that such measures are consistent with TRIPS.
Article 31 of TRIPS enables a government, or a third party authorized by government, to use the subject matter of a patent without the authorization of the patent holder. This authorization is called a compulsory licence. The scope and duration of a compulsory licence must be limited to the purpose for which it was authorized, as well as non-exclusive, non-assignable and predominantly for domestic supply.
Prior to gaining a licence, efforts to obtain authorization from the rights holder on reasonable commercial terms must have be made and been unsuccessful. However, there's no need to seek a voluntary licence in the case of a national emergency or other circumstances of extreme urgency, or in cases of public, non-commercial use.
Lastly, article 6 of TRIPS provides for parallel importation of patented medicines. Parallel importation allows countries to obtain patented products from other countries without the authorization of the patent holder. This can be legally permissible in countries applying the legal doctrine of exhaustion of rights.
These three flexibilities—measures to protect public health, domestic compulsory licences and parallel imports—were the only TRIPS flexibilities available until it became clear that they were inadequate to address HIV/AIDS. Countries requiring AIDS medicines did not have the domestic capacity to manufacture the drugs they needed.
In 2003, countries with manufacturing capacity were empowered under TRIPS to export patented products to eligible importing countries having insufficient or no pharmaceutical manufacturing capacity. Compulsory licences for export could be issued for amounts necessary to meet the identified needs of an importing country, with imported medicines clearly identified as produced under this system, and with the importing country required to take reasonable measures to prevent re-exportation of products.
The wisdom of a TRIPS waiver must be assessed against the backdrop of these flexibilities I've just described, taking into account today's barriers—not the HIV ones but the ones that confront manufacturing and access of COVID-19 medical products in light of our collective experience under the current TRIPS framework.
This brings me to my third point, which is that Canada's experience shows that the effectiveness of a TRIPS solution requires careful consideration and implementation.
Canada was the first country to attempt to implement compulsory licences for export to enable access to AIDS medicines after AIDS killed three million people in 2003 alone. The Jean Chrétien Pledge to Africa act would have empowered Canadian generic drug manufacturers to manufacture and export medicines to least-developed countries being ravaged by AIDS.
The political and corporate will was there in spades, but the implementation was unsuccessful. Only two drug shipments were ever exported. The restrictions were considered by manufacturers to be impractical, because new operations were needed just to enable the licences, which themselves, were valid for only two years and only eligible for one renewal. There is no other success story to speak of anywhere in the world.
Contemporaneously, brand name manufacturers of AIDS medicines began to issue voluntary licences to generic manufacturers to supply AIDS drugs to the developing world. This campaign started slowly around 2006, but many millions of generic AIDS medicines were being exported at pennies on the dollar within a few years. This approach was replicated for hepatitis C drugs in the mid-2010s. Although domestic compulsory licences have continued to play a meaningful role in enabling domestic access to essential medicines, brand name manufacturers have developed their own global access solutions that have played a significant role as well.
It's 2021, and the cauldron of access to medicines policy solutions continues to stir as we confront COVID-19. We have learned what we can and can't do with TRIPS. We've learned what brand name companies have been able to do to support global access. A good decision regarding the TRIPS waiver will be based on identification of the true barriers to access and the successful targeting of those barriers, taking into account extraordinary global health efforts over decades across the stakeholder spectrum.
To determine if a TRIPS solution is warranted, TRIPS member countries should identify what COVID-19 vaccine access will be enabled by the solution, over and above what's already enabled by existing TRIPS flexibilities, and members should co-operate to facilitate and remove barriers to that increased access, whether they be imposed by TRIPS or otherwise.
If, on the other hand, a TRIPS solution is unlikely to enable meaningfully faster or broader vaccine access, or there are other more effective solutions, then TRIPS members should come together to support other solutions that will facilitate that access. Canada should not place the burden of proof on proponents or detractors of the TRIPS waiver, but rather undertake its own critical assessment and support what it thinks will work best.
The common goals are shots in arms and saving lives. We at IPIC applaud the committee for taking seriously any initiative that will help achieve these goals in Canada and around the world.