Why is this so inexpensive? Why/how does it cost $65 per month instead of $1000?
The medication used as PrEP is patented, which means that only one company, Gilead, is legally allowed to produce and sell emtricitabine/tenofovir in Canada and other developed countries. As Gilead has no competition, they can charge whatever price they feel the market will bear.
Developing countries, such as those in sub-Saharan Africa, clearly cannot afford to pay $1000/month for essential anti-HIV medications. Companies like Gilead have, fortunately, agreed to not enforce their patents in these countries. This allows the production and distribution of generic versions of their drugs in resource-poor settings. As a result, over two-thirds of the world’s anti-HIV medications are now produced in India. Other major producers of generics include South Africa, Thailand and Brazil.
By purchasing this medication from a country where it is legally produced and distributed in generic form, participants of the Davie Buyers Club are circumventing one company’s monopoly and price tag which is unaffordable for the vast majority of individuals and, arguably, the healthcare system itself.
Is generic PrEP as good and as safe as the brand name?
Mylan and Cipla are the companies that produce the generic emtricitabine/tenofovir (RICOVIR-EM and TENVIR-EM, respectively) described on this site. Mylan is the second largest manufacturer of generic medication in the world. Cipla is also a large generic medicine manufacturer, with over one million people living with HIV currently taking their anti-retrovirals worldwide.
Both of these companies’ formulations of emtricitabine/tenofovir have received tentative approval by the United States Food & Drug Administration (US FDA). See 087 on the list for Mylan and 168 for Cipla. ‘Tentative’ FDA approval means:
If the product still has marketing protection in the U.S., FDA issues a “tentative approval” rather than a “full” approval. The “tentative” approval signifies that the product meets all safety, efficacy, and manufacturing quality standards for marketing in the U.S., and, but for the legal market protection, it would be on the U.S. market.
In summary, this status of FDA approval means that this version of generic emtricitabine/tenofovir is equivalent to the brand name and meets all quality standards that would allow it to be on the shelves of US pharmacies next to Truvada®, if this were not legally prohibited due to Gilead’s patent.
How do I know that the medication is legit? Can I get my pills or my blood analyzed to make sure?
There are reports of clinics in London, UK, who have used therapeutic drug monitoring (TDM) to confirm that the drugs are in present (and in effective/safe amounts) in the blood of people who are taking generic PrEP which was ordered online. There have been no reports available to-date of TDM revealing counterfeit or faulty generic PrEP. The use of TDM for this purpose in BC has reportedly been done for a few individuals, but there is a small research study of TDM planned for spring/summer 2017 **see 11-Jun-2017 update below**
UPDATE 03-Sep-2016: The HIV/MSM clinic 56 Dean Street in London, England, has published a summary of results of TDM on 162 blood samples by patients on generic PrEP (including Ricovir-EM). They reported zero counterfeits. Click here to read the summary.
UPDATE 26-Oct-2016: At the International Conference on HIV Drug Therapy in Glasgow, a researcher from 56 Dean Street presented data showing adequate blood levels of drug among 234 patients who purchased generic PrEP online. Though this did include Mylan’s Ricovir-EM, most samples were of Cipla’s Tenvir-EM.
UPDATE 07-Nov-2016: There are reports of half a dozen Vancouverites taking Ricovir-EM who have had TDM through St. Paul’s Hospital — all with good results. There is no official channel through which generic PrEP users can access TDM yet, but talks are underway. Ask your doctor (and stay tuned!)
UPDATE 26-Mar-2017: Dynamix has posted the batch certification supplied by Mylan for for the current lot of generic emtricitabine/tenofovir being distributed (lot 3061516, exp Nov-2019). You can view it here: Page 1 and Page 2
UPDATE 22-Apr-2017: 56 Dean Street presented this poster at the British HIV Association conference, showing TDM data on 277 patients using generic PrEP.
UPDATE 11-Jun-2017: a research study measuring drug levels of generic PrEP has launched in Vancouver. Click here to learn more.
Why can’t I ship PrEP directly to where I live, in Canada?
Canada Border Services Agency prohibits the importation of medication by mail or courier both ‘on paper’ and in practice. Because they physically inspect parcels that are incoming to Canada, they will find and confiscate any medication you attempt to have delivered to you. The only way that is legal, and the only way that works, is to import a 90 day supply (maximum) on your person with a valid prescription.
The exception: visitors to Canada (e.g. work visa or student visa holders, NOT Canadian citizens or permanent residents) may import personal medication directly to their home address in Canada. Click here for more details.
Is this illegal?
First of all: I am not a lawyer. However, the research I have done shows that none of the steps in this process are illegal in any of the relevant jurisdictions.
- Manufacturing generic emtricitabine/tenofovir in India: legal
- Purchasing generic emtricitabine/tenofovir in Thailand: legal
- Importing a 90-day supply of FDA-approved medication to the US for personal use: legal (only importation of unapproved medication is illegal)
- Importing a 90-day supply of medication for personal use in to Canada on your person (i.e. not by mail or courier), with a valid prescription: legal
Can the government or businesses purchase or distribute generic PrEP? Can the government force Gilead to reduce the cost of Truvada®?
No. Canada, BC, its health authorities and pharmacies are required to follow the law and respect Gilead’s patent rights, so they can only use Truvada®. The province can negotiate modest price reductions — but only for drugs purchased by Pharmacare, not for drugs purchased by insurance companies or by you as a private consumer. The government cannot order a private company to sell a product at a particular price. Out-of-control drug costs are not unique to Truvada® — Gilead’s hepatitis C treatment Harvoni® costs over $650 PER PILL ($55,000 for a 12-week course of treatment).
Doesn’t Truvada®’s patent expire in 2017? Does this mean there will be affordable PrEP in Canada next year?
Yes, the patent expires on 25-July-2017. However, patent expiry doesn’t create a free-for-all of competition and plummeting prices. Medication going off patent is more of a process than an event. On 25-July-2017 begins the “first-generic” phase — where one single additional company is allowed to sell emtricitabine/tenofovir in Canada. First-generics typically result in a roughly 20% reduction in price compared to the brand name. With an anticipated price tag of $700+ per month, the Canadian generic PrEP next year will still be completely unaffordable.
Update 23-Jun-2017: there has been discussion online and a segment on CBC News that a generic version of PrEP has been approved by Health Canada and may be available to purchase in Canadian pharmacies as early as the end of July this year. The cost is rumored to be around $250CAD per month. If the report is accurate, this price would still be unaffordable for most Canadians to purchase out-of-pocket, but it may make provincial governments and private insurers more likely to include PrEP on their formularies (list of covered drugs). Stay tuned.
What’s with the name of this website?
The name is a reference to the 2013, Academy Award-winning film Dallas Buyers Club which portrayed people affected by HIV/AIDS in the 1980s who could not access anti-HIV medications. The film’s protagonist imported medications in order to circumvent regulations, monopolies and other barriers to access for people in need. The comparison, I hope you will agree, is not unreasonable. Davie Street in Vancouver’s West End is home to many LGBT people, services, and businesses. It is widely considered to be the hub of gay culture in Vancouver.
Who are you and what inspired you to make this website?
I was invited by CATIE to share the story of DBC for their PEP/PrEP webinar on 2017-Mar-17. You can read the transcript of my statement here.
Is this generic medication meant for people in resource-poor countries? Will Canadians buying anti-HIV medication online make it less available to people who need it in those countries?
The companies who manufacture generic emtricitabine/tenofovir are permitted to produce it (depsite Gilead’s patent) so that it can be accessible to the developing world. However, I have talked with Dynamix about sourcing — they get the medication directly from Mylan, the manufacturer. I found it reassuring that the medication is not coming from hospitals, clinics, or any part of the supply chain that would impact locals who need it. I would never participate in a process where medicine was diverted from the mouths of local people living with HIV to instead be sold online to foreigners.
What’s the difference between PrEP and Treatment as Prevention (TasP)?
PrEP is the use of anti-HIV medication by HIV-negative guys to prevent them from becoming HIV-positive, if exposed. TasP is when an HIV-positive person takes anti-HIV medication and achieves an undetectable viral load (amount of virus in the blood is so low that our monitoring test can’t find it), which makes them essentially un-infectious i.e. unable to transmit HIV to someone else (while preserving and improving their own health and immune system!)
PrEP involves the negative person taking anti-HIV meds, while TasP involves the positive person taking anti-HIV meds. Both approaches are highly effective at preventing HIV transmission.
PrEP uses two anti-HIV drugs combined in one pill, emtricitabine/tenofovir (aka Truvada, Ricovir-EM, Tenvir-EM). HIV treatment may also use these medications, in addition to a third (and sometimes a fourth) agent, or it may use different medications entirely. There are over 30 different medications approved for the treatment of HIV in Canada, while only one combination pill is approved to prevent HIV.
To learn more about TasP, click here.