The UN’s 2016 High-Panel report on global access to medicine opens with an inspiring message: “Never in the past has our knowledge of science been so profound and the possibilities to treat all manner of diseases so great.” It is hard to debate that recent advancements in targeted cancer therapy and HIV drug development indicate a bright future for the Rx world. The potential for positive change may go unrealized, however, if access to medicine remains limited. To serve the 3.5 billion people without basic medical services, along with the 100 million who find themselves in extreme poverty because of high medical costs, governments and organizations have to confront the complex economic forces undermining global access to medicine. This article will discuss two such forces and consider how international actors have responded.

Too Big to Heal?

Economic orthodoxy holds that the equilibrium of a product’s supply and demand will determine its price, but medication prices do not adhere to this rule. This is because firms in the pharmaceutical industry possess the key to market distortion. Monopoly power or the ability for firms with outsized market shares to raise prices without experiencing a corresponding drop in sales. Pharmaceutical companies tend to obtain monopoly power for several reasons, such as:

  1. High entry costs, especially those associated with research and development. This excludes smaller, potentially disruptive firms from the market.
  2. The continuation of company consolidation. In the past 20 years, a group of 60 different pharmaceutical companies shrank to a mere 10.
  3. Large profits. Profits are huge, with the 10 highest-earning companies netting a 20 percent profit margin on average. This allows these companies to fortify their already-large market share. Most importantly, once a company patents a drug, it holds exclusive title to the production and distribution of that drug for 20-25 years.

During that period, no lower-priced, generic substitutes can enter the market. Equipped with this uncontested control, these companies can charge high prices for their products, as those who need them will have no other choice but to bear the cost. Yet some, especially individuals in poorer countries dealing with diseases like Hepatitis C and cancer, simply cannot afford these costs.

There are many individuals and corporations who are attempting to solve this problem, however. For example, GlaxoSmithKline (GSK), a pharmaceutical company based in London, England, is trying to put an end to exorbitant prices for prescription drugs in low-income countries. In March 2016, it announced that it would not seek patent protection for its drugs in 50 of the world’s poorest countries. By doing this, the company opened the path for smaller companies to bring lower-priced, generic versions of their drugs to the market. So far, the approach has been effective, earning GSK the top spot in the 2018 Access to Medicine Index. The positive publicity it receives from the ranking will hopefully motivate other companies to follow suit.

R&D Incentives

While the economics of monopoly power generates the problem of overpricing, the incentives of research and development make it such that many medicines needed in low-income countries go underproduced. As mentioned above, patents spell large rewards, but it costs $800 million on average for a company to obtain one and to bring a drug to the market. This pressures companies to develop the drugs that are most likely to produce a substantial financial return. Additionally, as the UN High-Panel notes in its report, this means that widespread, treatable diseases can oftentimes go unaddressed. For example, antimicrobial-resistant viruses and parasites threaten to kill as many as 10 million people annually by 2050, yet drug companies worldwide have developed virtually no new antibiotics in the past 25 years. In the absence of this innovation, however, public-private R&D partnerships have proven to be a successful substitute. The Global Fund is an example as it has saved 27 million people that malaria, HIV/AIDS and tuberculosis threatened by raising money from both public and private sources and collaborating with domestic task forces and commissions.

A Reconceptualization

Economic barriers to improve global access to medicine remain, but more and more people are starting to conceptualize the problem as an ethical one rather than an economic one. However, ensuring access to health care and maintaining market efficiency are not mutually exclusive. For example, cost-efficient drug production techniques are necessary to disseminate medicines at reduced prices. But other times “policy incoherencies,” as the UN High-Panel report calls them, force decision-makers to choose between the promotion of economic innovation and the provision of public health. Thanks to leading companies like GlaxoSmithKline and compassionate organizations like the Global Fund, the international community is starting to opt for the latter.

James Delegal
Photo: Flickr

HIV Drug Implemented in Kenya
In 2017, there were approximately 36.9 million people living with HIV/AIDS worldwide. Additionally, 6.1 million of those with HIV were located in western and central Africa. Kenya, a country in eastern Africa, had approximately 1.5 million people living with HIV/AIDs in 2017. That same year, an HIV drug implemented in Kenya started to successfully combat this deadly immune system virus. Unitaid and the Kenyan government simultaneously introduced it to the country.

Dolutegravir and Antiretroviral Therapy

The new HIV/AIDS drug, Dolutegravir or DTG, received approval in 2014 and is the most recent and effective antiretroviral drug used in the treatment against HIV/AIDs. DTG has been the drug of choice in high-income countries for its antiresistance properties, few side effects and easy one pill a day treatment. In 2015, the World Health Organization recommended this drug replace other first-line regimens for adults and adolescents. Recently this drug was not available in low-income countries, like Kenya, because of its high cost.

In 2018, only 62 percent of people with HIV/AIDs had access to antiretroviral therapy, which was an increase from the previous year. This corresponds to the 23.3 million people who were able to receive treatment, however, approximately 14.6 million people could not access treatment. In Kenya, 75 percent of adults with HIV/AIDs received treatment in 2018, which increased from 2016, when only 64 percent of people received treatment. One reason for the increase in HIV/AIDs testing is the partnerships between the government of Kenya and Unitaid that began in 2017 which introduced the generic brand of DTG.

Now, the generic brand of this life-saving drug has been available to people in Kenya since early 2018. This new HIV drug implemented in Kenya has the potential to make life-saving drugs more accessible to those who would normally not be able to afford it. In 2017, a number of nonprofits including the Bill & Melinda Gates Foundation, Unitaid, USAID, PEPFAR and others agreed to a pricing agreement to help make the drug more affordable in developing countries. This pricing agreement would allow public sector purchases at $75 per person, per year.

Side Effects of Other Drugs

Before the introduction of DTG, the first-line drug in Kenya was Efavirenz, an antiretroviral medication with side effects for some users including nausea, dizziness, rash and headaches. When the pricing agreement first emerged, the Kenyan Ministry of Health decided that the first round of DTG it distributed would go to 27,000 people who suffered the negative side effects from efavirenz. Then, the Ministry of Health assigned various other health clinics to receive the drug until it could become available to the entire country.

The number of new HIV/AIDs diagnoses in Kenya has halved over the last decade to approximately 80,000 people a year. The new HIV drug implemented in Kenya will only help decrease the number of people suffering from HIV/AIDs. Comprehensive sex education, HIV/AIDs testing centers and the continuation of drug pricing agreements will help alleviate the prevalence of HIV in developing countries, like Kenya.

Hayley Jellison
Photo: Flickr

Good News on Access to Hepatitis C CureMore than 300 million people worldwide are infected with Hepatitis C. With recent efforts to increase access to the Hepatitis C cure, elimination of the virus is now possible, according to the World Hepatitis Alliance.

Over the past two years, three million people around the world were treated for Hepatitis C. The biggest deterrent to access to the Hepatitis C cure was funding, with prices for the drug being as much as $1000 for one pill. Fortunately, though, Doctors Without Borders has made access to the drug treatment available at a much more affordable price.

Gilead Sciences released their cure for Hepatitis C, known as sofosbuvir, in 2013 at $1000 per pill. In 2015, Bristol-Myers Squibb released a similar treatment, known as daclatasvir, for $750. Recently, Doctors Without Borders was able to make generic forms of the drug available for as little as $1.40 per day, according to Reuters.

This is a major victory, as a large amount of the Hepatitis C population lives in low and middle-income countries. For them, a $1000 price tag is not affordable. The accomplishment means that more people will be able to access treatment.

The World Health Organization (WHO) has a goal of eliminating viral hepatitis by the year 2030. Because of the increased availability of the Hepatitis C cure, this can become a reality. However, the cure alone is not the only way for the virus to be eliminated.

There are key factors that WHO has outlined as steps necessary to eliminate Hepatitis C, but many countries have failed to implement them. These setbacks include a lack of political will and global funding mechanisms, poor data and surveillance, access to diagnostics and medicines and poor diagnosis rates, according to the World Hepatitis Alliance.

With that being said, there are currently nine countries on track to eliminate Hepatitis C by 2030, and three of them are developing countries. The countries are Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar.

Egypt has been innovative in implementing strategies that could eliminate the virus. So far, they have “pledged to test 30 million for hepatitis C by the end of 2018 by implementing mass screening initiatives (including assistance from the military), as well as mass-producing generic copies of DAA drugs for under U.S. $200 per 12-week course.”

By the same token, Brazil has “committed to gradually lift treatment restrictions in 2018, meaning that the country will be able to treat all people infected with hepatitis C.” In the past, the sickest patients have had priority for treatment.

When countries began to make the elimination of Hepatitis C a priority, the world will see results. Mongolia, Gambia and Bangladesh are among the countries that have begun to make progress towards getting on track to eliminate Hepatitis C. As more countries follow their lead, the goal of eradication will be reached sooner.

– Dezanii Lewis

Photo: Flickr


A large portion of the countries currently affected by hepatitis B and C are taking proactive approaches to eliminate the disease in their areas.

According to information from the World Health Organization (WHO), 28 countries representing approximately 70% of the global health burden are establishing hepatitis elimination committees. More than half of these countries have already committed funding for hepatitis responses.

Dr. Tedros Adhanom Ghebreyesus, the WHO Director-General, finds the commitment of these countries encouraging. “Identifying interventions that have a high impact is a key step towards eliminating this devastating disease. Many countries have succeeded in scaling-up the hepatitis B vaccination. Now we need to push harder to increase access to diagnosis and treatment,” Dr. Tedros said in a statement from the WHO.

Hepatitis (which means inflammation of the liver) is caused by toxins, certain drugs, diseases, heavy alcohol use and bacterial and viral infections. The disease is spread when blood or other bodily fluids enter the body of an uninfected person. Symptoms include jaundice (yellowing of the skin and eyes), fatigue, abdominal pain, swelling, chest pain, abdominal swelling, fever, and diarrhea.

The WHO report was released to coincide with World Hepatitis Day and is calling on countries to increase their commitment to end the disease. The current theme of World Hepatitis Day is Eliminate Hepatitis, focusing on increased awareness, diagnosis, universal vaccination and treatment.

Viral hepatitis affected 325 million people worldwide in 2015 and is responsible for 1.34 million deaths. The two main killer strains of hepatitis B and C affected 257 million and 71 million people respectively. WHO data shows that more than 86% of countries that were reviewed have already set national hepatitis elimination targets. More than 70% have begun to develop national hepatitis elimination programs by enabling access to effective prevention, diagnosis, treatment and care services.

Dr. Gottfried Himschall, WHO’s Director of the HIV Department and Global Hepatitis Program acknowledges that awareness of hepatitis is gaining momentum but also states that there are too many people living with hepatitis that don’t know they have the disease or cannot access treatment.

“For hepatitis elimination to become a reality, countries need to accelerate their efforts and increase investments in life-saving care. There is simply no reason why many millions of people still have not been tested for hepatitis and cannot access the treatment for which they are in dire need,” Dr. Himschall said in a statement from the WHO.

The World Hepatitis Summit in Sao Paulo, Brazil, organized jointly by the WHO, the World Hepatitis Alliance (WHA) and the government of Brazil, will bring together key players in hepatitis elimination. The summit will be held Nov. 1-3 and promises to be the largest global event to advance the viral hepatitis agenda.

Drew Hazzard

Photo: Flickr

Hepatitis C
Hepatitis C is an infection transmitted by contact with infected blood or other body fluids that can result in fatal liver disease. The World Health Organization (WHO) reports that Hepatitis C infects more than 185 million people around the world, and 350,000 people die from the infection every year. In the Ukraine, more than two million of its 45.2 million population are infected with Hepatitis C.

Seventy to 80 percent of those with an acute Hepatitis C infection do not show symptoms, which can prove dangerous when trying to prevent the spread of Hepatitis C. The annual mortality rate from Hepatitis C in Ukraine has increased by 141.7 percent since 1990 (an average 6.2 percent per year).

Hepatitis C treatment can be prohibitively expensive for the world’s poor. In 2015, the lowest cost for the 12-week treatment course of Sofosbuvir, an antiviral used to treat Hepatitis C, was $900, a price not suitable for low-income Ukrainians suffering from the infection.

In 2013, the Ukrainian government approved the first National Targeted Program of HCV Prevention, Diagnosis and Treatment. The state budget only funds the treatment component of the program, and this funding accounts for a mere 20 percent of the existing need.

U.S. organizations are doing their part as well. The United States Agency for International Development (USAID) launched the EQUIP project to fight HIV and AIDS, but EQUIP and USAID recently partnered with the Ukrainian government to fight Hepatitis C in Ukraine. EQUIP provides a simplified system with two stages of testing and treatment for 4,000 patients with Hepatitis C. In the first stage, 800 people with serious cases of double and triple pathology – a combination of HIV, Hepatitis C and Tuberculosis — will be treated; in the second, 3,200 individuals will receive treatment. Patients will be given a fixed dose of Ledipasvir and Sofosbuvir.

EQUIP is aimed at developing new treatment protocols and calculating its cost for Ukrainian patients. As well as giving doctors the experience they need with the medication to effectively treat patients and consult with the Ukrainian Government to create programs to increase access to those who need treatment. EQUIP is determined to eliminate viral Hepatitis by 2030.

With a combination of national and international efforts, we can end the spread of Hepatitis C in Ukraine.

Tiffany Santos

Photo: Google

Hepatitis C Drugs
Three years ago, a 90 percent effective hepatitis C medication, called Sovaldi, was released by Gilead Sciences. A three-month round of treatment costs $84,000. Janssen Pharmaceuticals released its own drug, Simeprevir, at $66,000 per round of treatment, and other pharmaceutical companies like AbbVie and Zepatier charged similar prices as they released their own hepatitis C drugs.

Hepatitis C is a blood-borne disease that can lead to liver cirrhosis and liver cancer, as well as other neurological problems. Worldwide, there are four times as many patients infected with hepatitis C as there are with HIV. About 150 million people live with chronic hepatitis C and 500,000 people die of hepatitis C complications every year.

Before Gilead, Janssen and other companies developed their newer, more effective medications, hepatitis C patients were treated with ribivarin and interferon, an antiviral drug and an immune-system modulator. The drugs caused fatigue, nausea and depression, and after one year of treatment, only 50 percent of patients were cured.

The WHO added hepatitis C drugs to their list of essential medicines, which they update every two years and some pharmaceutical companies offered deals with low-income countries. Gilead, for example, sold Sovaldi for $900 per round of treatment in Egypt in 2014.

The Drugs for Neglected Diseases Initiative made a deal with an Egypt-based pharmaceutical company last spring to sell a highly effective drug combination for $300 per treatment round.

Hepatitis C is especially prevalent in Egypt, affecting over 10 percent of the population, because of a vaccination campaign in the 1960s and 70s where syringes were reused for multiple patients. The disease is so widespread that barbers wear gloves and use disposable razors. Hepatitis C has even been spread between family members through sharing toothbrushes and nail clippers.

However, 80 percent of new infections happen in medical centers; in response to these figures, UNICEF and the WHO are working with the Egyptian government to educate both clinicians and the general population about hepatitis C.

Many patients await treatment, but the Egyptian government anticipates treating 1 million people for hepatitis C in 2016. As the cost of treatment decreases and sterilization and infection control practices are improved, the presence of hepatitis C in Egypt and elsewhere will diminish.

Madeline Reding

Photo: Flickr

world_hepatitis_day
July 28, 2015 marked the sixth World Hepatitis Day, designated by the World Health Organization (WHO) in 2010. According to the WHO, there are 400 million people with Hepatitis B or C, 240 million and 150 million, respectively. This amounts to 1.5 million deaths per year from viral hepatitis, which translates to 4,000 deaths per day that could be prevented with awareness and understanding regarding prevention.

Despite the disease being the seventh leading cause of death, everything is available to prevent infection and death, according to WHO Global Hepatitis Program team leader Stefan Wiktor. The most common method for treatment are injections. An estimated 16 billion injections are done yearly. Unfortunately, 40 percent of them are unsafe. WHO is promoting the exclusive use of sterile syringes that are specific for hepatitis treatment, to prevent unsafe injections.

While both Hepatitis B and C attack the liver and cause acute or chronic illness, there are different methods to treat each of them. For Hepatitis B, there is a vaccine, lab tests to screen out infection and safe treatment injections. Treatment can control the virus, but doesn’t cure it. All the more reason to know that Hepatitis B is transmitted through bodily fluids, and usually happens from mother to child. It is most prevalent in sub-Saharan Africa and East Africa. Unsafe injections of Hepatitis B account for 32 percent of infections.

Hepatitis C provides a little bit more hope. Its medications can cure almost everybody, but they cost $84,000 in wealthy nations, for a 12-week treatment. Egypt has been able to negotiate $900 for the medications. WHO believes prices will go down in the future.

To prevent Hepatitis C, it is worth knowing that it is a blood borne virus which is most commonly transmitted with drug use. Unsafe injections account for 40 percent of infections. WHO Service Delivery and Safety Department Director Edward Kelley comments, “preventing unsafe injections is key to curbing this epidemic”.

Despite the expensive medications for Hepatitis C, there has been a breakthrough this year. An inexpensive allergy medication has been discovered to block the virus so it doesn’t infect the liver cells, according to the U.S. National Institutes of Health. The antihistamine, chlorcyclizine, and similar “re-purposed” drugs were tested for their effectiveness against viral and bacterial infections in a high throughput screening method used in the analysis of government-approved compounds.

The only thing left is to determine a therapeutic dose for its use in the treatment of Hepatitis C, potentially giving millions of people who can’t afford the current $84,000 treatment.

– Paula Acevedo

Sources: Science Translation Magazine, Voice of America 1, Voice of America 2, World Hepatitis Day Campaign
Photo: World Hepatitis Day

Controversial Hepatitis C Drug Patent Rejected by China-TBP
In June 2015, China rejected Gilead Sciences, Inc.’s patent application for a drug related to its controversial but highly curative hepatitis medication, Solvadi. China rejected the application for the sofosbuvir prodrug, although it had previously granted a patent to Gilead for the base compound in the drug, also identified by its generic name, sofosbuvir.

A prodrug is a precursor of a drug. It is inactive or partially inactive until it is metabolically converted within the body. The Initiative for Medicines, Access & Knowledge, a group of lawyers and scientists based in New York, opposed the patent application on the grounds that the drug is not a new invention; it is “old science” derived from a line of antiretroviral drugs. I-MAK and Natco Pharma Ltd. did the same in India when Gilead’s hepatitis C drug patent request was turned down in January. I-MAK also legally challenged Gilead’s patents or patent applications in Argentina, Brazil, Russia and Ukraine. Such challenges are hoped to enable the production of a much less expensive generic version of Solvadi.

Gilead, a California-based firm, has been criticized for its pricing of Solvadi at $1,000 a pill in the United States. The 12-week course of treatment costs $84,000, a prohibitive cost for rich and poor alike. Adding to the cost, Solvadi must also be used in combination with at least one other antiviral drug. Since December 2013, when sofosbuvir was first approved in the United States, Gilead was sufficiently pressured to lower the price, agreeing to do so in 2014 for 91 developing countries.

Hepatitis C is found around the world but is most prevalent in developing countries, especially Central and East Asia and North Africa.The World Health Organization (WHO) estimates that as many as 150 million people are infected with chronic hepatitis C. The influential organization recently added Sovaldi to its list of essential medicines and pressed for lower prices.

Solvaldi/sofosbuvir offers a far better treatment plan than drugs currently in use: a 12- to 24-week course of once-daily pills with few minor side effects and a superior rate of cure. The currently used drug, interferon, is administered by injection several times a week for at least six months with a number of major side effects, and most patients suffer a relapse requiring more treatment.

According to Doctor’s Without Borders’ Director of Policy and Analysis, Rohit Malpani, Gilead’s price should reflect the cost of research and development, but, instead, it reflects what it believes the market will bear. This is because, he adds, Gilead paid $11 billion to acquire Pharmasset, the original producer of the drug. Other countries have made agreements with Gilead for lower prices. Egypt, which has the highest prevalence of the disease, has a deal with Gilead to lower its price by 99% after rejecting Gilead’s bid for a patent. India has also been in talks with Gilead to reduce the price since 2014.

No vaccine exists to prevent hepatitis C. According to the WHO, 350,000 to 500,000 people die every year due to liver diseases resulting from hepatitis C. Without a much less expensive generic version of Solvadi, it is unlikely that this figure will change any time soon.

– Janet Quinn

Sources: BioPharmaDIVE, IRIN, Reuters 1, Reuters 2, World Health Organization,
Photo: Everyday Health

hepatitis_c_drug
Gilead Sciences Inc., a drug company based in California, has licensed Sovaldi, its highly effective but expensive Hepatitis C drug, to seven Indian drug companies to distribute the drug to 91 developing countries at a much lower cost.

With approximately 180 million people suffering from Hepatitis C and nearly 350,000 dying each year in countries of low- and middle-income, the licensing will allow many of these people to receive treatment they most likely would not have been able to receive at the original cost.

The licensing agreement provides the Indian companies with direct access to Gilead’s manufacturing process so that production can be scaled up immediately and as quickly as possible.

Hepatitis C is typically transmitted through medical procedures, intravenous drug use or sexual intercourse, and it can remain undetected and unnoticed for a number years, eventually causing liver scarring and failure.

Chemically known as sofosbuvir, Sovaldi is radically more effective than previous injection regimens. Clinical trials showed a 90 percent cure rate after 12 weeks of treatment, a substantial increase over the 60 percent cure rate of previous treatments. Moreover, previous treatments had typically required taking numerous pills a day and antiviral injections, making the routine of Sovaldi, one pill a day, particularly appealing as well.

However, Gilead has received criticism regarding how extraordinarily expensive the drug is, costing $1,000 for one pill or $84,000 for a 12-week course in the United States. Its next-generation is expected to cost even more.

Gilead is planning to release its own brand of the drug in India for about $10 a pill or 1 percent of the cost in the United States. With India accounting for more than half of the world’s affected population, the cheap price is especially promising. In addition, Egypt, having the highest prevalence of Hepatitis C in the world, is also going to be provided with Sovaldi at $10 a pill by Gilead.

The seven Indian generic producers are allowed to set their own prices, and Gilead’s planned prices are expected to force the seven Indian companies to charge even lower prices to compete. They are also to pay royalties based on their sales to Gilead under the licensing agreement.

The licensing agreement also includes the next generation of Sovaldi, which is a combination of sofosbuvir and the experimental therapy ledipasvir, currently being tested by U.S. regulators.

In the U.S., officials have said Gilead’s drug could drain Medicaid budgets and increase private insurance premiums. In addition to the intense criticism the company has attracted domestically, Gilead’s licensing choices have attracted criticism due to their omission of middle-income countries that struggle to afford Sovaldi as well.

In more developed countries that were not included in the licensing agreements, such as China and Brazil, Gregg Alton, Gilead’s executive vice president, has stated Gilead will sell the drug at more than $10 a pill.

Regardless of the controversial nature of the Gilead’s licensing choices, the provision of a cheaper Hepatitis C drug to much of the world’s affect population is going to make a powerful impact and serve to help alleviate poverty around the world.

– William Ying

Sources: Gilead, Reuters, New York Times, Time, Wall Street Journal
Photo: Flickr