@MSF Video: Patents and the fight for #generics

Intellectual property protects those items that we can’t live without – think Netflix and the iPhone 7 – and those that we would surely die without, including life saving and extending medications.  Today’s video covers the latter and the barriers much of the developed world faces courtesy of patent laws that protect pharmaceutical companies.  This issue has come to recent attention as the UN’s Panel on Access to Medicines published its recommendations to Big Pharma’s chagrin.

At the crux of the UN Recommendations is a struggle that pits profits against people.  Enacted in 1995 by the World Trade Organization, the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) introduced minimum standards for protecting intellectual property, including patents on medicine.  TRIPS proved a boon for international trade, but set a 20-year patent on novel medication.  Only after the patent lapses can generic alternatives hit the marketplace.  It is at this point when many lifesaving and extending drugs are first available to the developing world.  The price tag of a medication to treat HIV/AIDS can drop from $10,000 per year to $200 due to generics.

Under TRIPS, each country has the right to a grant compulsory license, as stated in this excerpt:

Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected:

(b)   such use may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of national emergency or other circumstances of extreme urgency or in cases of public non-commercial use. In situations of national emergency or other circumstances of extreme urgency, the right holder shall, nevertheless, be notified as soon as reasonably practicable. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly;

In layman’s terms, if it is in the public’s best interest, generic drugs can be pursued without the patent holder’s consent.

A few years after TRIPS, South Africa attempted to pass an act that would grant a compulsory license for antiretroviral therapy in response to a staggering HIV/AIDS epidemic. The act was met with a lawsuit by 40 multinational companies and the United States, citing South Africa in violation of the TRIPS agreement, though executed in the midst a public health crisis.  Despite controversy, President Nelson Mandela signed the act into law and the lawsuit was eventually dropped.  In response, the World Trade Organization signed the Doha Declaration in 2001 to further clarify the right to grant compulsory licenses.

Nearly 20 years after TRIPS and Doha, the developing world continues to suffer from catastrophic levels of health inequality.  Africa, among the hardest hit, is home to nearly half of all tuberculosis cases and 91% of HIV-positive children. Countries that attempt to circumvent TRIPS, even in the direst of public health crises, are subject to retaliation by termination of trade agreements that help keep their economies afloat.

Earlier this year, Colombian Health Minister Alejandro Gaviria, warned a large pharmaceutical company, Novartis, that a compulsory license to pursue a generic form of a popular cancer drug was imminent if Novartis didn’t lower its prices.  In a letter from the Colombian Embassy in Washington, Colombia’s government was threatened by the United States with withdrawal of support to join the Trans-Pacific Partnership trade zone and funding to facilitate a peace deal with a longstanding rebel group.

The exorbitant cost of pharmaceuticals can also threaten consumers in developed countries.  Recent outcry over the soaring price of the anaphylaxis drug, EpiPen, has many in the United States worried. The price of EpiPen has gone from $60 to over $600 in recent years and are now exclusively sold in two-packs, further increasing the cost for consumers.  A similar product, Adrenaclick, is not considered equally therapeutic to EpiPen and pharmacies are unable to fill prescriptions.  Another pharmaceutical company applied to make a generic version, but the application was rejected by the FDA.

This has led to repercussions such as children carrying expired EpiPens and EMTs dispensing epinephrine by syringe, which makes it much harder to administer the correct dose.  A recent article in the American Journal of Medicine suggests that EpiPens be added to a list of preventive medicines, effectively lowering the copay without lowering the overall price of the drug by the pharmaceutical company, Mylan Specialty.  The cost would likely be shifted to consumers in higher deductibles.

In light of the UN recommendations, what is the next step to guarantee medications are available to those who need them?  Dr. Bernard Pecoul of Drugs for Neglected Diseases Initiative urges action, not apathy:

“Governments mustn’t allow the report to become yet another exercise that describes the current failures of the medical innovation system without contributing concrete steps to address those failures. Responsibility now clearly falls on them at the highest political levels to act by putting in place innovative and practical solutions.”


Let’s Get Ethical: Giving Untested Experimental Drugs to Ebola Patients

West Africa is in the throes of the worst Ebola outbreak to date. Ebola virus disease, the hemorrhagic fever caused by the Ebola virus, has been seen in small but often deadly outbreaks in tropical sub-saharan Africa since its discovery in 1976. Though researchers are fairly certainly that it is transmitted through bush meat, and fruit bats are suspected, no animal species has been confirmed as a reservoir. Combined with the fact that the virus is highly contagious and so often deadly (usually because there is little to no medical infrastructure in areas where outbreaks occur), it is the source of international fascination and fear. It is the perfect plot device for outbreak movies and sensational media reports – a mysterious ailment from the heart of darkness that could rear its ugly head in our packed population centers at any moment.

Although it’s not quite as scary as movies like “Outbreak” would have you believe, the havoc that it is currently wreaking in West Africa is most definitely real. The most recent update from WHO puts the death count at 932 and the number of cases (both suspected and confirmed) at over 1,700. Guinea, Liberia, and Sierra Leone have been battling the virus since the spring, and last week it made its way to Nigeria and there was even a suspected death in Saudi Arabia. We all know that international air travel means that these types of illnesses are only a plane ride, which raises the question of why we haven’t made more progress in developing a vaccine or treatment for such a devastating disease.

Frankly, most global health and development professionals know the answer – if the only market for potential drugs is among the poor in central Africa, commercial drug companies won’t exactly be lining up to put money into the research:

The factor preventing such trials in humans, though, has been cost, said Dr. Daniel Bausch, an associate professor of tropical medicine at the Tulane University School of Public Health who is currently stationed at the U.S. Naval Medical Research Unit 6 in Lima, Peru.

That’s because, while the National Institutes of Health and the U.S. government often fund the early animal safety and efficacy testing of a vaccine, pharmaceutical companies typically fund the human clinical trials to take a drug or vaccine to market.

“When you have a population or situation with Ebola where it only sporadically occurs, and it occurs really in the world’s poorest populations, it’s not exactly an attractive candidate for the pharmaceutical industry on the economic side,” Bausch said.

That all changed, however, when two American aid workers who were treating Ebola patients in Liberia fell ill with the virus themselves. Dr. Kent Brantly, a doctor working with Samaritan’s Purse, and Nancy Writebol, a nurse employed by Service in Mission, are now all over U.S. and global headlines as the first Westerners to contract the virus – and, because of their privileged status, as the first people to receive an experimental treatment in the early stages of development before being flown back to Emory for medical care (despite objections from Donald Trump and Ann Coulter).

Though several people have raised objections to bringing Americans back stateside for treatment (particularly at what it probably cost), Emory is probably the safest and best-equipped facility to treat and contain the patients. Samaritan’s Purse is footing the bill for transporting them, so no government funds are being used. Bringing them back to the states for treatment is not so much of an issue, in my opinion – but using an experimental drug which is untested in humans is another matter.

At first glance, an outbreak of a disease with a high fatality rate (usually 40-70%) and no cure seems like the perfect situation to bypass the standard drug testing and approval process, which can take several years. However, it is the recklessness generated by precisely this type of desperate situation that raises ethical dilemmas. Does informed consent really count when patients are panicked at the prospect of imminent death? What if the drug is administered to the afflicted on a large scale and turns out to be toxic, or causes long-term disability? Who determines which patients to prioritize and how to protect those most vulnerable – such as children or pregnant women – who may react very differently to the drug?

Additionally, the fact that the drug has only been given to the two Westerners raises a very different, but equally important, problem. The international community has struggled for years to bring critical medicines to populations with the greatest need, who are simultaneously the least able to afford them. The fact that this experimental treatment was given to two aid workers – who, unlike their patients, have the support of large and wealthy organizations and will be more able to access the needed high-quality supportive care than their own patients – raises some disturbing questions.

The WHO has announced that it will convene a panel of medical ethicists to discuss and provide guidance on the issue. The pharmaceutical companies that develop and manufacture the drug are, naturally, chomping at the bit to get a large production run funded in order to provide ZMapp, the experimental serum, to a large number of Ebola patients. It is unclear how the global health community will move forward. But perhaps it can serve as a lesson to the pharmaceutical industry to take a more active interest in developing therapies for diseases that may not seem lucrative at first glance. Perhaps then we’ll be prepared for an unexpected multi-country outbreak – instead of having to scale up an untested drug developed by a tiny biopharmaceutical.

Vaccine Ping-Pong: GAVI and MSF’s Advocacy Campaign for Vaccine Access

MSF (Médecins Sans Frontières, also known as Doctors Without Borders) recently posted a set of three animated videos about child vaccines as part of their latest advocacy campaign. The first one, titled “We Need Better Tools to Save Lives” is pretty straightforward – it’s a basic explanation of what is needed to vaccinate children, how MSF struggles to fill that need, and a quirky analogy about what it is like to not have that need filled. Simple enough.

The second video is a lot more direct. The show how the number of vaccines in the standard childhood vaccination battery, as well as the cost of those vaccines, have increased in the last decade. The video then takes a direct shot at pharmaceutical companies for keeping vaccine prices high in order to prioritize profits over saving lives. The debate on drug prices is a heated one, and everyone seems to have their own opinion on what “fair prices” for drugs are, but it is clear where MSF stands.

The last video was the one I personally found to be the most interesting. “Dear GAVI, Please Let Us Access Your Discounted Vaccine Prices” talks about how qualified governments are allowed to access GAVI’s low vaccine prices, but NGOs are not given access to them. MSF provides a more detailed description of their perspective on the issue in this press release:

MSF is also troubled by the fact that non-governmental organizations and humanitarian actors are excluded from accessing the GAVI-negotiated price discounts. MSF is often in a position to vaccinate vulnerable groups, such as refugee children, HIV-positive children, and older unvaccinated children who fall outside of the typical age range for standard vaccination programs. However, MSF has not been able to systematically access the lowest prices negotiated by GAVI, having to resort to lengthy negotiations with Pfizer and GSK over the last four years to access the pneumococcal vaccine. While the companies have offered MSF donations, this is not a sustainable, long-term solution for MSF as we work to respond quickly to needs in the field, and wish to expand vaccination of vulnerable groups in an increasing number of countries.

GAVI responded to the MSF campaign in this statement:

First, we agree with MSF – we do all want the same things. We want all children everywhere to be protected by immunisation. In fact, GAVI is proud to include MSF as a member of the GAVI Alliance. They are an active member of the steering committee of the GAVI Board’s Civil Society Organisation Constituency.

MSF first formally raised the issue of access to the same prices GAVI pays for vaccines at the GAVI Board meeting in December 2012. This issue is currently being discussed through the Alliance’s Governance channels. We find it disappointing that MSF, which knows and is engaged in the GAVI Governance process, has chosen to take on this issue as a public campaign.

MSF then offered this statement in response:

Thank you GAVI for publicly acknowledging our request for access to your vaccine prices. MSF has been frustrated by bilateral discussions, which have been ongoing for a few years now, with vaccine manufacturers and the GAVI Alliance on finding a solution for humanitarian actors to access pneumococcal conjugate vaccine at the GAVI price, and we anticipate that accessing GAVI prices for other new vaccines (for rotavirus, HPV) will also be a challenge. We ask GAVI to fast-track this process so that MSF can vaccinate more kids as soon as possible.

We often talk about issues of coordination (or lack thereof) and collaboration between different aid groups and funding organizations in the wake of natural disasters and humanitarian crises. It is interesting to see this kind of friction between different groups who are trying to do exactly that because of how complicated it can actually be.



To protect children right now, we have to use vaccines that aren’t well suited to the job they have to do. Vaccines can’t take the heat — they have to be kept at between 35 and 46 degrees at all times. But we need to use them in some of the hottest places on earth. For this and other reasons, we need better-adapted vaccines to protect children from life-saving illnesses.



Children are now protected with 11 vaccines; up from six vaccines a decade ago. The price of vaccinating a child has sky-rocketed. It cost $1.37 to vaccinate a child 10 years ago, now it’s $38.80. That’s a whopping 2,700 percent increase. So how do we decide how many vaccines children need? Is it based on how much money you can make, or on how many children’s lives can be saved?



The price to vaccinate a child has risen by 2,700 percent over the last decade. Countries where Doctors Without Borders/Médecins Sans Frontières (MSF) works will lose their donor support to pay for vaccines soon, and will have to decide which killer diseases they can and can’t afford to protect their children against. MSF is asking the GAVI Alliance to open up their discounted vaccine pricing to humanitarian actors that are often best placed to respond to vaccinating people in crisis.

The GAVI Alliance is an international public-private partnership whose stated mission is to increase access to immunization for children in poor countries. GAVI co-finances the cost of vaccines with qualifying countries. Participants include governments of developing and donor countries, the World Health Organization, UNICEF, the World Bank, the vaccine industry, research and technical agencies, the Bill & Melinda Gates Foundation and other philanthropic organizations.

Drug Wars: What does a free trade agreement between India and the EU mean for generics?

When I was a junior in college, I had to give a presentation for my honors Molecular Genetics class. The hot topics that year were avian influenza and HIV. I had just been accepted into the School of Rural Public Health’s MPH program, so I decided to get in the HIV-line, but with a twist: rather than present a paper on the mechanism of infection or a mutant viral protein, I would pull the lens back and look at the disease from a public health standpoint. It was an eye-opener for a lot of my classmates, most of whom were biochemistry majors whose only exposure to HIV had been through pictures of Western blots in peer-reviewed journal articles. Some of the strongest reactions were to cost of care, especially drug prices: when I cited several drugs that entered the market at $25 (darunavir), $29 (tipranavir), or even $61 (efuvirtide) for one day’s dose in the U.S., eyes widened and jaws dropped across the room.

A round white pill.
Flickr, doug88888

The war on drug prices is a long-standing, bitter battle between the pharmaceutical industry and humanitarian groups and lobbyists, with governments and regulators perpetually caught in the middle. International health and humanitarian organizations argue that access to inexpensive medicines is vital to the survival of the poor who need them, and that Big Pharma is driven by greed and cares only for its profit margins. Pharmaceutical companies counter that intellectual property protection and patents encourage innovation and the development of newer and better drugs. The solution to this dilemma in developing countries, including India and many African nations, has been generics. India’s patent laws make it easy for regulators to deny drug patent applications, allowing Indian pharmaceutical companies to use the data from clinical trials already performed to get approval to produce cheap generic versions of patented medications. India is the world’s leading producer of inexpensive generic drugs – its pharmaceutical industry makes most of its money by producing generic versions of drugs patented by Western companies – which has earned its reputation as “the pharmacy of the developing world.” India supplies 80% of the medicines distributed by medical humanitarian organizations in poor countries; in particular, 93% of ARVs going to HIV patients in these countries are Indian-made.

The EU is currently negotiating a free-trade deal that may change all of this: in addition to agricultural tariffs and work visa agreements, Europe is trying to negotiate a period of exclusive access to pharmaceutical companies’ research and clinical trial data. No specific amount of time has been finalized, but without information from the clinical trials already conducted, generics manufacturers would have to conduct their own testing to register their products. Opponents of this provision fear that this will drive up the cost of generic medicines and make them unaffordable for the poor. Médicins sans Frontières (Doctors without Borders) has launched their “Europe! HANDS OFF our Medicine” campaign specifically against this component of the agreement. The WHO and the UN’s special rapporteur on the Right to Health Anand Grover are also concerned, and the Indian generic pharmaceutical industry is predicting a global health crisis if the trade agreements lead to production restrictions. The European Commission insists that the negotiations will not negatively impact India’s generics industry, but worries will persist until a draft of the agreement is released.

The ever-continuing debate underscores the need to find a balance between encouraging economic growth and innovation, and ensuring affordable access to medicines for those who need them. Though the start-to-finish cost of producing drugs can admittedly cost billions of dollars, the question of whether it justifies such high new value benchmarks has not yet been settled. The fact that so many millions wait in line for these drugs begs this ever-persistent question: what is the point of charging so much for drugs that so many need if so few can afford them?

Whoonga: South Africa’s New Crack

Question: What costs $3, contains AIDS medication and rat poison, and is smoked with marijuana?
Answer: One day’s dose of whoonga, South Africa’s latest, and most tragic, drug craze.

The word “whoonga” is more of an exclamation than an actual name. Invented in Durban, South Africa, this cream-colored powder is hustled by drug dealers who charge 20 rand ($3) for one day’s dose. This mixture of detergent, rat poison, and antiretrovirals (ARVs) is initially taken up as just another addition to a cheap array of recreational drugs for the unskilled and unemployed. For some, it helps them relax or get to sleep; for others, it makes them feel like the “the best person ever.” But this pleasant high soon turns nasty. The drug is extremely addictive, and users report cravings and withdrawal symptoms after the very first hit ranging from stomach cramps and night sweats to depressed heart and lung function. Addicts need several hits to make it through the day. What begins as a way to pass the time becomes an all-consuming habit that drives people to steal, commit crimes, or worse – steal or sell HIV medications.

South Africa has the highest HIV burden of any country in the world. As it finally begins to make meaningful progress against the disease, whoonga could not have come at a worse time. The South African government provides free ARVs to AIDS patients who qualify for economic assistance, and this has now become an unfortunate source of drug supply. Corrupt health workers and clinic staff are selling ARV medications on the whoonga market. AIDS patients have been robbed as they leave clinics with their pills. In some cases, they are selling their own medications to whoonga dealers. And now reports are emerging of desperate addicts intentionally trying to get infected when they can no longer support their habits through petty crime. The cruel irony of it all is that there is no evidence that the HIV medications actually do anything to create or enhance the high.

South African officials are aware of the problem, and so far, the drug has not spread outside of KwaZulu-Natal. However, the implications of the drug’s spread are frightening. What makes whoonga particularly insidious and difficult to combat is lack of information: many experiment with it without realizing what they are getting themselves into. One small organization, Project Whoonga, is confronting it head-on. Run by Vumani Gwala, this community-based support group is based in Kwadebeka, a large township outside of Durban, and has 45 addicts in recovery. While admirable, the organization needs all the help it can get in taking on this tragic menace. “This drug has turned our beloved township into a jungle,” laments Gwala. “Families with addicts live in constant fear of vigilantes that threaten to get rid of this crime using violence and families have gotten their homes burned down.”