Evidence of meeting #40 for Industry, Science and Technology in the 40th Parliament, 3rd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was drugs.
A recording is available from Parliament.
Member, National Advocacy Committee of the Grandmothers to Grandmothers Campaign
These are the stories. I have one more.
Member, National Advocacy Committee of the Grandmothers to Grandmothers Campaign
How can you not pass this bill? You have the power to save lives.
Conservative
The Chair Conservative David Sweet
I want to advise the committee that late last night an e-mail was received regarding a witness from Apotex--Bruce Clark. He is not here because of unforeseen circumstances. We will have his remarks submitted. They will be translated into both official languages and distributed to the committee.
Why don't we go to our technological link first?
Mr. Livingstone, please give us your opening remarks for five minutes, please.
Angus Livingstone Managing Director, University-Industry Liaison Office, University of British Columbia, As an Individual
Thank you, Mr. Sweet.
I'd like to thank you for the opportunity to address the committee today. I'm the managing director of the UBC technology transfer office. I have about 20 years of experience in patenting and licensing university technologies, much of that in the biopharmaceutical sector. Over half of British Columbia's biopharma and biotech companies can trace their histories to UBC technologies.
At the outset, I'd like to acknowledge that I'm not speaking to you on behalf of the University of British Columbia--
Conservative
The Chair Conservative David Sweet
I'm sorry. Please move the mike closer, sir. We need to have a good, clear connection because of translation.
Managing Director, University-Industry Liaison Office, University of British Columbia, As an Individual
That's as close as it comes.
At the outset, I'd like to acknowledge that I'm not speaking to you on behalf of the University of British Columbia but rather as a member of the university community, and the views expressed are my own.
I'm very proud to say that in 2007, UBC was the first Canadian university to publicly adopt the global access principles, which, stated briefly, make a commitment to making UBC technologies available to developing countries for health, environmental, and security purposes. This position was strengthened in 2009 as we worked with Yale and Harvard to develop the statement of principles and strategies for equitable dissemination of medical technologies.
To date, UBC has included a number of global access provisions in its licence agreements, including requirements for compulsory licensing, at-cost provision of medicines, and return of country of source. UBC and its affiliated hospitals conduct over half a billion dollars of research annually, and about 60% of that is in the life sciences.
My world has changed dramatically in the past five years, and technology licensing is increasingly difficult with the global distress of both the biotech and venture capital industries. Meanwhile, government is asking us to demonstrate a return on investment on the considerable funds that they have given us to conduct research.
It's in this difficult environment that I am seeking global access terms in my licence agreements, and it can be a very difficult sell. Drug development is an expensive and risky business without adding global access provisions that would only be implemented after drug approval some 10 or 15 years hence, when the world that we all know will look considerably different than it does today.
In reviewing Bill C-393 and the previous hearings, some things are clear to me. Everyone salutes the goal of making medicines available globally to those in need. There are many stars that must align, from the access to affordable drugs, to local infrastructure, medical personnel, water, sanitation, and other social determinants. While Bill C-393 may help alleviate the access to affordable drugs issue, in and of itself it is insufficient to ensure access to those in need. However, it does seem reasonable to remove the cost barrier in areas where they may exist, and such is the intent of Bill C-393.
Given the need for pediatric formulations, access to second-line drug regimes, and changing patent laws in India and China, the need to access patent medicines may arise more frequently.
My caution lies in the implementation and the potential unintended consequences as the pendulum swings from regulations that, by virtue of Apotex's Rwanda experience, have been seen to be cumbersome and unwieldy to the one-licence, all-country unlimited solution proposed by Bill C-393, which, in my opinion, lacks sufficient checks and balances.
In particular, I am troubled by the lack of country-by-country approval process and a licence bound by time. Couple this with the opportunity for countries to accept drugs not approved by Health Canada or the pre-qualified program of the WHO and there is potential for drugs without adequate safety or efficacy profiles to be in circulation. Removing requirements for specific marking, colouring, or labelling invites diversion opportunities both to other countries and also to other economic classes within the country of destination.
While diversion has not been a substantive issue to date, I know that 95% of the WHO's essential medicines are off patent and the incentive for diversion will increase with the costing control in the differential associated with patented drugs, which is the subject of Bill C-393.
Another legitimate concern expressed to me by companies in the first world market is the potential for first world market consequences of third world market adverse medical events. This could result in the regulatory halt of the drugs used in Canada and/or a substantive drop in market opportunities.
Finally, I think we need to consider the possible consequences of one major event related to either diversion or adverse medical events. This, in my belief, would reduce the R and D investment potentially funded by pharmaceuticals in Canada. That being the case, it could diminish our ability to develop drugs within the country and certainly my abilities to license them in the university environment. If that's the case, it could result in reduced access to medicines by Canadians.
Pharmaceutical development is a global business, and it's possible for industry to avoid jurisdictions that present unacceptable risks.
In summary, I support the revisions to the Canadian access to medicines regime to improve the efficiencies and effectiveness, but this must be balanced with adequate checks and balances to ensure that access is delivered in a controlled and accountable manner.
Thank you.
Conservative
The Chair Conservative David Sweet
Thank you very much, Mr. Livingstone.
Now we're on to Emilou MacLean for five minutes, please.
Emilou MacLean Director, United States of America, Campaign for Access to Essential Medicines, Doctors Without Borders
Thank you. Bonjour. Good morning.
It is a pleasure and an honour to be here to testify. Médecins Sans Frontières is an international medical humanitarian organization working in over 65 countries, and I'm here to make primarily three points based on our experience.
First, quite simply, medicine saves lives in poor countries. It sounds quite basic, but it's important to say. Second, access to effective and affordable medicines depends on generic competition. Third, Canada can do more than it is currently doing to support access to medicines in developing countries.
The problem of access to medicines extends to any new drugs and to all diseases, yet AIDS continues to serve as a powerful example of both the dire needs and also the potential provided by price-reducing generic competition and, importantly, political will.
MSF began to provide AIDS treatment in 2001. At the time, a myriad of people said it was not possible in poor countries. There was insufficient infrastructure, it was said. Poor patients will not take their treatment regularly. Even, “Africans do not even have watches, how are they are going to know when to take their treatment?” At the time, there were only 8,000 people in all of Africa on antiretroviral therapy.
Now, of course, these arguments ring hollow. At MSF clinics we now enrol thousands a year rather than dozens. We are innovative, based on the resources available. Nurse-initiated treatment is common and effective. Treatment is radically decentralized and simplified away from hospitals and towards health posts, under trees, and on the roadside. To the skeptics, it is working. Some 5.2 million are on treatment who would not be alive without it, as apparently you heard in a previous hearing. A 2006 study published in JAMA found that Africans are on average more adherent than patients in North America to treatment.
The treatment scale-up over the past decade has only been possible as a result of generic competition. Generic competition caused annual first-line ARV drug prices to plummet from over $10,000 per patient per year to $67 per patient per year for the most affordable generic combination treatment today.
I was in South Africa working with MSF in 2002 when our goal was to provide treatment for 180 people in a pilot project. That first batch of patented drugs cost more than the car that drove the medicines from the pharmacy to the clinic. That may be fine for a pilot project to prove the skeptics wrong, to make a dent in the overwhelming need, and to be a call to action, but MSF could not provide AIDS treatment for 160,000, as we do today, at the price charged by brand-name manufacturers--nor could the global fund, to which the Canadian government just contributed $520 million U.S. over three years. Forgive me for doing the U.S. calculation.
PEPFAR, a major procurer of AIDS drugs, has likewise acknowledged the significance of generic competition in its global AIDS contributions. Initially resistant to the use of generic medicines, PEPFAR now procures--in a recent study published--90% of its AIDS medicines from generic manufacturers.
PEPFAR estimated that it saved $215 million U.S. in 2008 alone through the use of generic ARVs--$215 million U. S. In one year, PEPFAR's cost savings from generic procurement are more than one year of Canada's contribution to the global fund. That's not to praise the United States or to denigrate Canada, but simply to show the profound significance of generic competition in bringing costs down and making a scarce resource more affordable.
But times are changing. The dramatic reductions from generic competition are no longer available for newer medicines as a result of the TRIPS agreement intellectual property requirements. Second-line AIDS medicines, improved first-line drugs, and newer medicines for all kinds of other diseases are and will be more expensive, sometimes prohibitively so. Fixed-dose combinations—three-in-one pills necessary for good adherence and rapid scale-up—cannot be created if patented by different manufacturers.
In human terms, 10 million are in immediate need of first-line AIDS treatment. Drug prices matter dearly for these people. There is also an approaching treatment time bomb, a phrase recently coined by the U.K. Parliament's all-party parliamentary group on AIDS. Increasingly patients will need to switch to newer drugs for long-term survival, but the price difference is massive between the cheapest first-line medicines, more often available in generic form, and improved first-line, second-line, and salvage therapy, more often not.
For second-line treatment, the cost differential is a factor of seven. For salvage therapy or third-line, it's a factor of at least 23, where it's even available.
Drug costs will increasingly limit patient options and swallow health budgets without dramatic price reductions. AIDS is only an example, and it need not be the case. Compulsory licences provide a mechanism to allow for generic competition despite patent barriers. Compulsory licences on efavirenz led to a 50% price drop in Thailand and a 77% drop in Brazil, allowing the additional treatment of 20,000 patients in Thailand and a threefold increase in Brazil.
A workable paragraph 6 decision is critical for countries with no or insufficient generic manufacturing capacity, particularly as even least developed countries are obligated to adhere to TRIPS and enforce patents by 2016.
In Canada's first attempt to implement the paragraph 6 decision, or the August 30 decision, as it's sometimes called, it created additional unnecessary barriers for these most disadvantaged populations needing to use the system because they lacked domestic manufacturing capacity. Why should the poorest of the poor be triply burdened?
MSF invested years, ultimately unsuccessfully, as you heard this morning from Rachel Kiddell-Monroe, trying to use the system. There was clear need, but the burden on countries and generic manufacturers was so substantial and the delay so long that we secured a WHO pre-qualified Indian generic before CAMR could be made workable.
Notably, it was not a question of an inability to compete with the Indian supplier. Once produced, the Apotex fixed dose combination was $143 U.S. per patient per year, compared to $176 U.S. per patient per year from Aurobindo and Cipla in India. Canada could compete on price, but Canada hobbled because CAMR mandated slow speed and ineffectiveness.
If someone in Ottawa, Toronto, or Quebec acquires HIV, she can expect to live to about 70 years of age, according to recent studies. But what is available for those in developing countries living with HIV? At Médecins Sans Frontières, we urge Canada to support the easiest possible access to affordable medicines in developing countries with insufficient generic manufacturing capacity.
I lead into the industry representatives, and I'll say that the industry will always have excuses. I hope the government won't.
Thank you.
Conservative
Grant Perry Vice-President, Public Affairs/Reimbursement, GlaxoSmithKline Canada
Thank you.
Honourable members, thank you for the opportunity to appear today to discuss GSK's experience with Canada's access to medicines regime and our company's extensive efforts, both globally and locally, to improve access to health care in the developing world.
There are three points I'd like to make. First, CAMR is efficient and effective at achieving its objectives. Second, the provision of medicines is only one essential element in addressing health care issues in the developing world. Third, GSK is committed through action to addressing access to medicines through frameworks like CAMR and other means. GSK's experience with CAMR has shown that it is an effective framework for Canada to meet its international obligations and for increasing developing world access to much needed medicines.
While 32 other countries in the EU and elsewhere have passed legislation similar to CAMR, to the best of our knowledge Canada is the only country from which a shipment has actually taken place. This first shipment of a triple combination HIV/AIDS drug to Rwanda from Apotex in Toronto took place in September of 2008.
First allow me to congratulate Apotex for stepping up to address the issue in Rwanda. The following chronology of events leading up to that shipment is important, because it demonstrates that only 68 days elapsed from the time Apotex made the request of GSK until they were granted authorization to begin exporting Zidovudine and Lamivudine to Rwanda. Please allow me to review this timeline with you.
You will recall that Bill C-9 came into effect in May of 2005, creating the Jean Chrétien Pledge to Africa Act, now called CAMR. Almost a full year passed before GSK and two other patent donors were approached by Apotex requesting voluntary licences. GSK responded promptly, indicating a willingness to discuss the granting of a licence and seeking clarification on key questions relating to anti-diversion and patient safety, both very real issues to GSK. Apotex did not respond at that time to our request for further information. Fourteen months later, GSK received another request from Apotex for a voluntary licence, and within 26 days we provided our consent to the commissioner of patents to issue an authorization pursuant to CAMR. Ultimately, one more year passed before the first shipment of a triple combination product was shipped from Apotex, not because of red tape, not because of a complex and lengthy process, but for reasons outside the administrative and legal process and not within the control of GSK. Apotex took more than one year to start shipping their generic drug to Rwanda.
Our experience is that CAMR can and does work when put to the test. In October 2009, GSK announced that it remains ready and willing to do our part within the framework of CAMR to ensure that the objectives are being met. We must not lose sight of the needs of patients in the developing world. While CAMR includes important safeguards and transparency requirements that help encourage R and D investment and support new drug discoveries, we must refrain from using CAMR as a means to re-open the intellectual property debate in Canada. While Canada lags behind other countries in IP protection, the protection afforded by Canada's rules holds the key to developing new medications that can fight and eventually eradicate many diseases that ravage the developing world. We must not become embroiled in an IP debate that would create further instability and drive away crucial investments in our country.
This brings me to our second point. The provision of medicines is only one essential element of many needed to address health care. As you've already learned from Ms. Downie and others, simply delivering medicines, whether brand or generic, doesn't nearly address the challenges developing countries face, such as poor sanitation and education, as well as social barriers. There are significant infrastructure issues related to the availability of health care workers, distribution networks, and health care facilities.
Finally, corruption and criminal activity can lead to diversion of medicines from the intended patients, either within the country itself or even before the medicines reach the national authority. We need a broader approach, one that goes beyond CAMR, and this is our third point.
GSK has long taken an innovative, responsible, and sustainable approach to improving the health of patients in the developing world. Working in partnership with governments, NGOs, and the private sector, GSK has among other things deliberately focused our R and D efforts on diseases of the developing world, such as HIV, TB, and malaria. We have sought to eliminate many diseases, including lymphatic filariasis, one of the world's most debilitating diseases, and we have consistently offered preferential pricing on antiretrovirals and vaccines.
This legacy of commitment is not enough. We have stopped saying it is not our fault there is no infrastructure to deliver health care and have started asking ourselves what else we can do to ensure that infrastructure does exist. Consequently, we have established several new initiatives that continue to address these broader issues and specifically advance GSK's leadership role. Specifically, we have recently begun sharing our intellectual property on neglected tropical diseases by setting up a patent pool and inviting others to join us.
We have opened the doors of our research centre, dedicated to diseases of the developing world, to all other researchers. We have reduced the price of our patented medicines in the least developed countries to no higher than 25% of what it is in the developed world, and we have committed to reinvest 20% of the profits made on medicines in these countries in local health care infrastructure projects. Finally, we have expanded the donation of albendazole to treat children at risk of intestinal worms, a condition that the World Health Organization's first report on neglected tropical diseases confirms causes more ill health in school-aged children than any other infection.
I am very proud to be part of the renewed partnership agreement between Canada's Research-Based Pharmaceutical Companies and Health Partners International of Canada to help speed the delivery of medicines and other supplies to people in need across the developing world.
In closing, we have illustrated that CAMR is only a piece of the larger puzzle, and that piece has proven to work effectively and efficiently when used. GSK's belief is that our collective efforts and intentions are best focused by serving the broader issue of improving health care in the developing world through leadership and action.
I thank you for your time, and I welcome any questions.
Conservative
The Chair Conservative David Sweet
Thank you, Mr. Perry.
Now we'll move on to Mr. Williams and Mr. Dotto. I understand you're going to share your five minutes, so Mr. Williams, please begin.
Russell Williams President, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Thank you, honourable members. We are very pleased to join you today. I hope that we can contribute to the discussion and that the debate generated will be conducive to progress and innovation in access to medicines for developing countries.
I agree with the opinions shared today, but I think that these points of view are lacking a more practical side.
Canada's Research-Based Pharmaceutical Companies supports the principles of CAMR, but this regime is just one of the many partnerships and initiatives we have for fighting disease in the developing world. You heard about some of them today. You heard about others before, when CIDA officials appeared before you early in the fall.
There are many Canadian initiatives to help address health needs in developing countries. For our part, the Canadian member companies have collaborated with Health Partners International of Canada since 1990 and have delivered more than $250 million in donated medicines around the world. Globally, and I think this is very important, the innovative pharmaceutical industry is the third-largest funder of research and development on diseases in the developing world, behind the U.S. government and the Bill and Melinda Gates Foundation. Much remains to be done, but the evidence suggests that these voluntary efforts are paying off.
At the end of 2008, more than four million adults and children from low- and medium-income countries received antiretroviral treatment That's 10 times more people than just five years ago.
Sub-Saharan Africa, where the need is greatest, was the largest recipient. A similar improvement was noted in the delivery of drugs to pregnant women to prevent the transmission of AIDS to fetuses.
CAMR has worked when the rules have been followed, but there are several provisions in the bill before us that concern us.
First, the current obligation to seek voluntary licence within CAMR would be repealed.
Second, the existing country notification on the limits of product quantities would be repealed.
Third, the bill would make a licence open-ended, even if the circumstances that led to it no longer existed.
Fourth, the bill would allow medicines to be exported from Canada to developing countries without Health Canada's safety approval. This would create a double standard with respect to the safety of medicines used in this country and the medicines sent abroad for humanitarian purposes.
Finally, there is the potential for diversion to other countries. The global corruption report identifies procurement, distribution, and counterfeit medicines as sources of corruption in pharmaceutical supply. The WHO reports that one out of four medicines in developing countries is counterfeit. In particular, we would ask what purpose is served by renewing the ability to terminate a licence if the humanitarian products are found to be re-exported from a country where they were originally sent. That is a straightforward question.
What concerns me most is the amount of time and effort that has been focused on this bill, when with the collective energy and unanimity I'm hearing about with respect to trying to make Canada do more, we could focus more on some of the voluntary infrastructure programs and the partnerships the industry has been making, and it would be more successful.
I will now yield the floor to Mr. Dotto, of Abbott Laboratories.
Laurence Dotto Director, Government and External Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
Thank you.
I'm very happy to be here today. I have been volunteering in Africa for eight years through our family-focused charity that provides assistance to women and children in Malawi. So far, we have successfully completed more than 15 local sustainable development projects, which were mostly health-oriented.
When I first visited Malawi, in 2003, access to HIV testing was extremely limited. Companies like Abbott provided free screening tests, but administering those tests was always an issue.
Today, fortunately, testing is much more widespread. There are HIV treatment programs in rural areas, and most small hospitals have now set up HIV programs with trained volunteer counsellors, paid counsellors, and are receiving antiretroviral drugs through several NGOs.
Today, the drug supply issue has essentially been solved in many of these countries. Generic HIV drugs are starting to stream in from India and South Africa. Hospitals today are receiving free HIV drugs and free antimalarial drugs through these NGO government partnerships.
In my view, the biggest challenge facing countries like Malawi today is a continuing absence of health care infrastructure. There's only one doctor for 50,000 Malawians and one nurse for 20,000 people. As well intentioned as Bill C-393 may be, it does not address the real challenges, the core issues of poverty, education, nutrition, and access to basic health care faced by less developed countries.
In my view, if Canada were to make a serious contribution to the fight against HIV/AIDS in Africa, here are a few priorities to consider: greater support for prevention of mother-to-child transmission counsellors who go from village to village and counsel and test pregnant mothers; more mobile health clinics to travel to the villages; and how about transportation funds to allow an HIV-positive mother to take that minibus to an ARV clinic that's two days' walk away from where she lives?
Programs to identify HIV-positive children are urgently needed so they can find their way to a treatment program. With 80,000 HIV-positive children in Malawi and only a few hundred in Canada, what could be more important than trying to support the Malawi of tomorrow?
In my view, these are the real needs and these are the practical ways to build a more effective health care infrastructure in countries like Malawi.
Conservative
The Chair Conservative David Sweet
Now we'll go to rounds of questioning. I'll just remind members, as well as witnesses, to try to keep your questions succinct and your answers succinct to get the most value out of this.
For five minutes, Mr. Garneau.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
Thank you, Mr. Chair.
I want to begin by saying to Mrs. Rennie that her testimonial was very moving, and the part I remember the most was her comment that this can only be solved if we increase the supply of medicines to those who need them.
I've had the pleasure of having the Grandmothers for Africa twice in my office during the past year. I had two grandmothers, so I know how powerful grandmothers can be. I want to say again, with respect to the intent, I share that intent 100% to get those medicines to those who need them.
I'm an engineer. I think in very Cartesian terms, and I'm saying to myself, some people are saying that CAMR doesn't work as written and we need Bill C-393. Other people say it does work and we don't really need to focus on that, but rather we should be focusing on all of the other challenges with respect to infrastructure and other matters, which I think you probably agree with, that all those other things also need to be addressed.
But as part of my trying to understand this argument, it's very difficult for me to understand who is right, because the positions are diametrically opposite in many ways. I dearly wish that Apotex had been here this morning. It's very unfortunate they're not here, because I had some definite questions to ask them.
Given that they're not here, I'm going to ask my questions to Mr. Perry and Mr. Williams, and I'm coming back to this issue. Under current CAMR rules there's been one case, the Rwanda case, and Apotex was involved. I want to hear again, because this timeline is really confusing me. It was 68 days that was supposedly required for the three providers of patent medicine to grant a voluntary licence to Apotex. Then it took a year for the medicines—supposedly 15 million pills were authorized—for the first batch to get there, and then another year for the second batch.
I'm trying to understand why, when it appears that the process worked well in terms of granting of the voluntary licence, it took a year to get the medicines over there. I'd like to understand that a little bit better, so I'd like to hear your interpretation. I wanted to ask this question of Apotex, but they're not here. I'd like to ask Mr. Perry and Mr. Williams what their view is of that.
Mrs. Rennie and Mrs. MacLean, I'd be glad to hear your views too.
Vice-President, Public Affairs/Reimbursement, GlaxoSmithKline Canada
With respect to why it took Apotex a further year after the authorization or licence, you'll have to ask Apotex that; unfortunately, I'm not in a position.
I can say that within three weeks of the original request, we responded to them to say that we were willing to discuss a voluntary licence, but we did not hear back from them. Three months later, we rewrote them saying that we had not heard from our original request and asking whether they wanted to speak with us. It took until July of the next year—from the previous September—to get yet another request, and 26 days later we told the commissioner of patents that we were willing to abide by the rules of CAMR and allow for authorization of our product.
As to why it then it took a year after that, unfortunately I'm not in a position to respond.
President, Canada's Research-Based Pharmaceutical Companies (Rx & D)
There's been speculation that it's price negotiations, etc., but we don't know that. What we can clearly say, and we have all the dates documented and have submitted the documentation to the Senate committee, is that it took 68 days of CAMR. All the delays, whatever the causes were, are not about the bill we're talking about.
Director, United States of America, Campaign for Access to Essential Medicines, Doctors Without Borders
I would largely rest on the comments made by Rachel Kiddell-Monroe in the earlier testimony, because she was the key person based in Canada who was working on this within MSF. But the biggest burden from our side came earlier; that was trying to get a country to come forward and commit to be part of this, given the pressure that countries face when they attempt to use compulsory licences, both from industry and from developed-country governments who are resistant to the use of compulsory licences.
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
That's a generic comment. I want to know why it took a year in this case.
Director, United States of America, Campaign for Access to Essential Medicines, Doctors Without Borders
I'm going to rest on the comments that were made by Rachel Kiddell-Monroe earlier on this, because we were not involved in the actual purchase of the Apotex—
Liberal
Marc Garneau Liberal Westmount—Ville-Marie, QC
That's what I need to find out; that's my problem.
Mr. Livingstone, you've had an involvement through UBC with the kind of issue we're talking about today. I'd like to ask you, what in your opinion is the most fragile part in this chain, based on your experience, when trying to provide life-saving drugs to those who need them in third-world countries? What is the most fragile part in that chain? We've heard about infrastructure that's lacking and about other things. I'd be interested in and would like to hear your viewpoint based on your experience at UBC with your colleagues, because I know you focus on this. That certainly is something that we in the Canadian Parliament should be focusing on as well.
Conservative
Managing Director, University-Industry Liaison Office, University of British Columbia, As an Individual
I think I would describe it, rather than as a chain, more as a network. In the case of access to medicines, it clearly has to be there, but whether sourced through patented drugs or through generics, there are multiple ways of getting access to medicines at affordable prices, and one or the other has to be there. There will clearly be issues in delivery within Africa, and the infrastructure and educational problems are critical as well.
So I don't think there is a “most fragile” part; in many cases, there are very viable alternatives that can be sought.