[Ip-health] Post from Sergey Kondratyuk: Possible treatments for COVID-19 could all be made for a dollar a day, say researchers.
pfehlner at revisiontx.com
Wed Apr 22 05:06:04 PDT 2020
The problem is getting the multi-million dollar investment in any medicine given the risk that it will not work or be safe, especially if it will be made available at or near cost, limiting profit. Funders willing to take that risk could develop all drugs for pricing at or below marginal costs of production. It’s just a question of whether there is enough risk capital seeking outcomes instead of profit as a return on investment. So far, not much.
We think that there is a sustainable middle ground: payers willing to share some of the development and commercial risk in return for stable, low price (and quality and supply). COVID-19 is an acute opportunity for risk impact investing to create products sold at or below marginal cost. Proving the model in the extreme would potentially open the door to a largely untapped source of innovative medicines through repurposing by establishing an effective alternative drug development and commercialization model.
Prizes? I’m not sure. Who gets the prize? What if there are multiple entities? The discoverer of a “drug” compound usually does little or nothing to make it into an approvable drug product. Let’s face it: discovery is relatively inexpensive and easy. Properly translating discovery into an approved product is expensive, takes a long time, fraught with uncertainty and error, and essential for public health and safety. That process often involves two or three entities after discovery. And what about manufacturing? Who will invest in the production line, a huge capital expense, and in the substantial ongoing cost of production? Possibly yet another entity. What about distribution? Approval of a new drug (even a repurposed one) does not lead to automatic use by doctors, sometimes because they don’t know about it, sometimes because of bias for established treatment or as a results of an unlucky first bad outcome with the new one, sometimes because of influence of other drug companies. Who is paying to inform and educate healthcare providers, and do they also get a prize?
Instead, impact investors seeking outcomes first and letting profit follow and payers seeking lower prices with price stability, by taking on some of the development and commercial risk, can create a sustainable system conducive to low price, high quality, innovative drugs.
So where is that capital? Where are the payers willing to put skin in the game? We are certainly looking for it!
President & CEO
reVision Therapeutics, Inc.
pfehlner at revisiontx.com
> On Apr 10, 2020, at 9:57 AM, Outterson, Kevin <mko at bu.edu> wrote:
> The article does not engage well on the R&D side of the question for the possible treatment drugs with remaining patent/exclusivity; instead they assume or ask for public funding of R&D costs including clinical trials. Prize-based approaches have the advantages of rewarding innovation more appropriately, but permitting distribution of drugs at or below marginal cost of production.
> Professor of Law & N. Neal Pike Scholar in Health and Disability Law - Boston University
> Executive Director, CARB-X
> Research papers at SSRN & Google Scholar
> @koutterson | 617 935 6517
> This email message (including attachments) is confidential (-contains trade secrets and/or commercial information). If you have received this message in error, please delete it immediately and reply to the sender that you received the message in error.
>> On Apr 10, 2020, at 7:51 AM, James Love <james.love at keionline.org> wrote:
>> ---------- Forwarded message ----------
>> From: Sergey Kondratyuk <skondratyuk at itpcglobal.org>
>> To: "ip-health at lists.keionline.org" <ip-health at lists.keionline.org>
>> Date: Fri, 10 Apr 2020 11:41:01 +0000
>> Subject: research on cost of possible treatments for COVID-19
>> Possible treatments for COVID-19 could all be made for a dollar a day, say
>> Research published today by the University of Liverpool, supported by ITPC,
>> reinforces a very simple message - pharma must not profiteer from a
>> Countries must not act hastily and stockpile any of the potential drugs.
>> Currently all the drugs being used in COVID-19 trials remain unproven.
>> However, there are other ways that countries can be prepared.
>> The tragedy already resulting from the COVID-19 pandemic must not be
>> exacerbated by the current health inequities in play.
>> We lay out the facts and a series of recommendations.
>> Drugs that are already in COVID-19 treatment trials can all be
>> mass-produced affordably, research from the University of Liverpool,
>> published today demonstrates.
>> The researchers ‘priced-up’ the key drug contenders. Some of them are
>> currently marketed for other uses, and priced at thousands of dollars per
>> person. Yet all of them can be produced generically – at a profit – for $1
>> a day, or less.
>> The effects of COVID-19 must not be exacerbated by our current patent and
>> pricing system. Patents for ‘new use inventions’ must not be granted on
>> existing drugs, as has regularly happened in the past, nor should they be
>> granted for any new drugs or diagnostic tests developed to treat COVID-19.
>> Instead, countries should adopt systematic, compulsory mechanisms that
>> expedite access to any medicines or technologies that may be needed in the
>> near future.
>> As the new research (
>> outlines, repurposing existing drugs to treat COVID-19 is vital for
>> reducing mortality and controlling the pandemic. Several promising drugs
>> have already been identified and are in various stages of clinical trials
>> If re-purposed drugs demonstrate efficacy against COVID-19, they could be
>> manufactured profitably at very low costs. Any existing patents or other
>> intellectual property barriers on the production, import and export of
>> these drugs must be overridden by governments.
>> The research was supported by ITPC’s Make Medicines Affordable campaign,
>> which challenges unmerited patents and other barriers to medicines, and
>> demands an end to inequitable pricing. Using an established methodology,
>> previously designed to find the fair price for HIV and Hepatitis C
>> medicines, the researchers estimated minimum costs of production, including
>> the costs of the active pharmaceutical ingredients (API). The methodology
>> includes factoring in realistic production and distribution costs for
>> generic manufacturing, and a 10% profit margin and tax on net profit.
>> Drugs in the World Health Organization trials
>> The 9 drugs covered by the research includes four of the five drugs in the
>> World Health Organization’s (WHO) Solidarity trial:
>> * Remdesivir, previously tested as an Ebola treatment.
>> This is an investigational medicine which has not been approved by
>> regulatory authorities anywhere in the world. The safety and efficacy are
>> not yet known.
>> The originator company, Gilead has said it will donate 1.5 million doses,
>> enough to treat 140,000 patients with severe symptoms for compassionate
>> use, expanded access and clinical trials.
>> This is not a philanthropic gesture; it is a way for Gilead to retain
>> control over production if the newly fast-tracked clinical trials yield
>> positive results. If remdesivir is proven effective, the only way to meet
>> global demand for it would be to allow technology transfer, including for
>> the drug’s active pharmaceutical ingredients (API), so that it can be
>> produced quickly and cost-effectively around the world. The research
>> estimates that this experimental drug can be produced generically for $9
>> per treatment course (estimated at present to be 10 days); since this is an
>> intravenous drug, governments would have to factor in additional costs for
>> its administration .
>> * Lopinavir/Ritonavir (LPV/r) is used as part of HIV treatment.
>> Reports indicate that the originator company, Abbvie, will announce that it
>> will not enforce patents on LPV/r, however this is not the same, or as
>> conclusive, as withdrawing patents. Currently used in lifelong
>> HIV-treatment, the annual costs can be astronomical for many governments.
>> In Ukraine, for example, thousands of people are without HIV treatment
>> because the health budget cannot stretch to cover the price Abbvie demands
>> per person per year ($730). Our campaign partner has been opposing Abbvie’s
>> unmerited, costly monopolies for years. At every stage Abbvie has fought
>> back vigorously so any promises that the company is currently making should
>> be viewed with caution. Lopinavir/Ritonavir (LPV/r)can be produced for $4
>> for 14 days, 7x less than what Ukraine pays.
>> * Chloroquine and hydroxychloroquine are very closely related; they are
>> used to treat malaria and rheumatology conditions respectively. Both drugs
>> are already being produced generically, although prices still vary, with
>> the highest prices being paid in China and the US. Although COVID-19
>> trials have yet to show whether either of these drugs are effective,
>> reports of their stockpiling by the US presents a risk of shortages for
>> other countries – and for people who need them to treat pre-existing
>> conditions. A pandemic cannot be contained when countries scramble to look
>> after themselves. It’s a short-sighted strategy. To treat a pandemic we
>> need equitable access. Cholroquine is $93 for a 14 -day course in the US,
>> which could be produced for $0.30 for the same period, and 14 days of
>> hydroxychloroquine could cost $1.
>> Solidarity, not stockpiling
>> Until efficacy is demonstrated, all treatments remain unproven. The WHO
>> “cautions against physicians and medical associations recommending or
>> administering these unproven treatments to patients with COVID-19 or people
>> self-medicating with them… Unnecessary stockpiling and the creation of
>> shortages of approved medicines that are required to treat other diseases
>> should be avoided.”
>> Andrew Hill, lead researcher, supports the WHO’s advice. He hopes the
>> research will enable all countries to prepare now so that they are in a
>> stronger position when or if a drug is ready to be rolled out, which would
>> save time and lives.
>> “If efficacy is demonstrated, countries need agreement now that the
>> relevant drugs will be available and affordable. Waiting until we know a
>> treatment is effective would cause further delay. But countries acting very
>> insular and competing for limited resources now is not the answer. Rapid,
>> mass availability at an affordable cost would be essential to ensure equity
>> and access especially amongst low- and middle-income economies.”
>> Hill continues: “There should be no intellectual property barriers
>> preventing mass production of these treatments worldwide. We need
>> technology transfer so that the methods used to manufacture the key drugs
>> can be shared with any country deciding to produce the drugs locally. Local
>> producers with sufficient capacities could also supply regionally. It is
>> essential to remember that the production requirements need to account for
>> existing uses of these medicines as well.”
>> A pandemic is not a ‘new market’ for business
>> Current list prices (the price negotiated between a company and each
>> country) of all the drugs considered by the research are significantly
>> higher than what they can be produced for, in all but one case. The
>> research compared a range of countries with different levels of economic
>> development to give a representative sample. Some of these treatments have
>> list prices over 100 times higher than the cost of production.
>> “Patents and other intellectual property (IP) barriers have prevented
>> access to life-saving treatments for too long,” says Othoman Mellouk,
>> ITPC’s Intellectual Property and Access to Medicines Lead. “It would be
>> immoral for any pharmaceutical company to profit from a pandemic. But based
>> on the track record of some of the pharmaceutical companies involved in the
>> trials, it is possible that they could view a pandemic as ‘new markets
>> opening up’ or as a financial opportunity. Old tactics used to profit from
>> existing drugs must be quashed conclusively.”
>> “If prices for the same drug vary in the way that they have been allowed to
>> in recent years, many countries will find themselves in an impossible
>> position where they can’t afford to treat everyone in need,” continues
>> Mellouk. “We’ve seen before that when decisions are made about who to
>> treat, that the most marginalised and vulnerable in society are the ones
>> with the most to lose.”
>> “It must be one, fair, price for all. The tragedy already resulting from
>> the COVID-19 pandemic must not be exacerbated by the current health
>> inequities in play. It cannot be a question of who to treat, but to treat
>> all, and that is only possible if medicine is affordable in every country.”
>> Research has now confirmed that the affordability of several drugs under
>> investigation for treating COVID-19 can be assured. Ensuring the widespread
>> availability of any approved drugs at the most affordable prices for health
>> systems to roll them out will depend on the immediate actions of
>> governments and the international community. These actions should include:
>> 1. Governments must immediately identify any existing patents and other
>> monopolies on potential drugs to treat COVID-19.
>> 2. Where patents exist, governments should put systems in place that allow
>> compulsory licenses to be granted automatically so no time is wasted if
>> drugs turn out to be effective against COVID-19.
>> 3. There must be no new patents on drugs with potential to treat COVID-19.
>> 4. Governments and the WHO must identify sources of API and ensure
>> technology transfer so drugs can be mass-produced locally or regionally and
>> 5. The capacity for local and regional production must be mapped and, where
>> necessary, upgraded, for taking on any additional requirements that may
>> arise for drugs approved for treating COVID-19; this is also important for
>> countries already facing potential shortages for drugs currently used in
>> COVID-19 treatment protocols or for other illnesses.
>> The world does not have the luxury to simply wait and watch the
>> developments on the COVID-19 treatment front. Decisions and systems need to
>> be in place now for the mass production and supply of any treatment that
>> may be approved.
>> There will be no excuses for our failure to do so.
>> Sergiy Kondratyuk
>> project manager | Global Team
>> Based: Kyiv, Ukraine
>> Mobile: +380673599323
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