Special reports - 26/May/2021

Fake drugs and how to protect the vulnerable

With non-communicable diseases increasingly becoming a major health issue for poorer and wealthier countries alike, securing access to the medicines used to control them is a key concern. Cost, supply and licensing are all challenges. Solutions to a number of the problems encountered are being tested in low-and-middle-income countries in an effort to improve availability.

In 2013 in South Africa, Tobeka Daki, a single mother of two, was diagnosed with stage three HER2 positive breast cancer, an especially aggressive and deadly form of the disease. Her oncologist told her she needed a life-saving drug for her type of cancer—one the World Health Organization (WHO) recommends as essential treatment, along with chemotherapy—to have a fighting chance.

Despite being a good candidate for the drug and having health insurance through her employer, Daki was unable to access the drug because of its high cost. For a year’s treatment, the price was $38,375, about three times the per capita income at that time. The high cost made the drug unavailable in the South African public health system, where 84% of the population seeks care.

Access to the drug was prevented by a structural barrier: South Africa’s patent laws allowed the drug’s manufacturer to hold multiple secondary patents that blocked biosimilars from entering the market until 2033, long after its patent should have expired.

Daki died at home in November 2016 without getting access to the medicine she needed. Her death led to the Tobeka Daki Campaign, supported by more than 31 organisations by February 2017. By July that year, the South African Department of Health had included the drug in its essential medicines list which meant patients in the public health system could ac- cess it. Daki’s story is just one example of the struggle faced by many patients living with non-communicable diseases (NCDs) when seeking life-saving treatments.

Two billion people do not have access to basic medicines, according to a WHO estimate. A former director of the organisation, Margret Chan, notes in a 2007-2017 ten-year review that along with poor health systems and infrastructure, affordability is the biggest factor that prevents people from accessing medicines, especially in low-and-middle-income countries (LMICs) where the cost of medicines is borne out of pocket.

 

 

Lack of access to medicines is an acute problem for people living with NCDs and LMICs bear two-thirds of the burden. It is in LMICs that low funding, scarce resources and the challenge of adapting to the dual burden of infectious diseases and NCDs causes acute suffering. Poor supply chain management exacerbates the issue, according to a 2015 review by non-profit organisation, PATH on access to diabetes drugs in low resource settings.

Affordability is just one factor. In LMICs, people living with NCDs must also contend with the risk of counterfeit products, lack of supply and patent and licensing barriers, which are also linked to affordability. Efforts to overcome the obstacles are showing promise, however, through cross-border partnerships, technology start-ups, strategies to nudge change through ranking systems and the implementation of policy measures, such as compulsory licensing.

 

THE WAR ON FAKE DRUGS

One in every ten medicines in LMICs are falsified, according to WHO. The counterfeit drug industry is worth up to $200 billion a year. Fake malaria drugs led to more than 122,350 deaths in sub-Saharan Africa in 2013, according to the 2019 article, “Falsified and Substandard Drugs: Stopping the Pandemic.

African countries bear the brunt of the problem, accounting for 42% of fake drug complaints between 2013 and 2017, says WHO. Countries with poor monitoring arrangements and weak health systems suffer most from counterfeit drugs. A few innovative start-ups, however, are working to resolve the problem and spoil the market for counterfeits by empowering consumers with information.

 

Ghana-based mPedigree uses text messages to help consumers find out if the drugs they are buying are fake

 

Founded in 2007 in Ghana, mPedigree uses text messages to help consumers find out if the drugs they are buying are fake. The process is simple—consumers can scan the barcode or scratch the medication package to reveal a code that they send to a toll-free number to determine its authenticity. Since its foundation, the company has worked with non-profits, governmental agencies and drug regulators covering Nigeria, East Africa and India reaching 100 million users.

Another such company is Medsaf, a Nigerian start-up, that connects manufacturers of authentic drugs directly to hospitals and pharmacies, with the added benefit that a more direct supply chain increases cost efficiency of delivery.

A cross-border partnership that has the potential to make a significant dent in the supply of counterfeit medicines is the 2019 treaty to establish an African Medicines Agency, which will come into effect once it is ratified by 15 African Union states. The agency aims to enhance the capacity of the countries to regulate medical products and ensure access to safe drugs.

 

 

BETTER LOGISTICS FOR HEALTHY STOCKPILES

NCDs, such as diabetes, hypertension, and cardiovascular disease, require long-term consumption of medicines. Their consistent supply to pharmacies is essential, but often difficult in LMICs.

Running out of stock, or “stockouts”, in public facilities represents a major barrier to drug access, according to a 2020 study on the accessibility of medicine in Uganda. Among the many factors affecting availability, the study found, are inaccurate forecasting of demand by facility staff, inefficient procurement or distribution mechanisms in the supply chain and inadequate budget allocation from the Ministry of Health to the facilities. Distribution cycles as long as four to eight weeks are another factor leading to wide fluctuations in availability of the drugs. The challenges are not unique to Uganda.

The Coalition for Access to NCD Medicines and Products, a multi-sectoral group of government agencies, private-sector entities, NGOs, philanthropic foundations, and academic institutions, has convened a technical working group and collaborated with government health ministries in Kenya and Uganda, to create an advanced forecasting tool specific to NCDs. “Without this methodology, health systems often forecast their commodity needs based on available funds and inaccurate past consumption patterns with insufficient service delivery data leading to stockouts or expired products,” says Marilyn Noguera, senior supply chain officer for NCDs at charity PATH: a member organization for the Coalition for Access to NCD Medicines and Products. In addition to the ongoing work in Kenya and Uganda, the coalition aims to scale up its tool for use in other countries in 2021, she adds

 

 

RANKING EFFORTS TO IMPROVE ACCESS

Since 2011, the Access to Medicine Index has ranked 20 of the largest research-based pharmaceutical companies on their efforts to improve access to medicines across LMICs. A change can already be seen in the 2021 index that could shorten the time people in lower-income countries wait for new vaccines and medicines. “Eight leading pharmaceutical companies are moving to systematically pair candidates in their R&D pipelines with plans for making them accessible in low-and-middle-income countries soon after the products are launched onto markets,” says the index’s Claudia Martinez, head of research.

The shift in working practice by so many companies is an improvement over 2018, when only one had adopted the approach, she adds. Access plans can cover activities such as pricing to ensure affordability, registering products for sale in countries facing high disease burdens and advance licensing agreements that allow manufacturers to start making generic versions.

 

THE PROBLEM WITH PATENTS

Despite the Tobeka Daki campaign and inclusion of the HER2 breast cancer drug on essential lists, the drug is still unavailable across all provinces of South Africa, says Soleme Meyer, advocacy manager for Cancer Alliance, a coalition based in the country. “Even now the drug is still priced high and a few provinces have refused to make the drug available in the public health system.”

South African laws do not allow for patent examination, which has led to disproportionately higher numbers of patents being granted there, compared to other countries. By filing multiple patents to prevent competition, a process known as “evergreening”, manufacturers help to support high drug prices. Evergreening also enables pharmaceutical companies to hold a monopoly on a drug beyond the mandated 20 years.

The approach is common practice in the US, which has the highest per capita spending on health care in the world. Among the 12 top-selling drugs in the country, 125 patents have been filed and 71 patents have been granted per drug, according to analysis by I-MAK, an advocacy organisation that works on drug policy reform in the US. The costs of the drugs have increased 68% since 2012; only one has decreased.

 

Health systems often forecast their commodity needs based on available funds and inaccurate past consumption

 

Even politicians in the US who have encouraged other countries to adopt their country’s patent policies have been deliberating on how to lower drug prices for their citizens. “Sadly, the situation has not improved. In the past five years, 13% of Americans have lost a loved one due to the unaffordable cost of prescription drugs. That figure is twice as high for people of colour,” says Priti Krishtel, co-founder of I-MAK.

The first step in ensuring the affordability of a drug is to ensure it undergoes the test of novelty when manufacturers seek secondary patents. In 2013, India’s supreme court delivered a landmark judgement that rejected a pharmaceutical company’s appeal for patenting a widely used cancer drug. The court’s ruling in the seven-year legal battle upheld section 3(d) of the Indian Patent Act that restricts granting of a patent for “incremental innovations” in many drugs unless they provide significant therapeutic advantages to existing molecules.

The court’s verdict had far reaching effects. “It alerted other pharmaceutical companies to be cautious and reduce the number of frivolous patents,” says Y K Sapru, founder of Cancer Patients Aid Association, a non-profit, that took action to make the drug affordable. Sapru cites World Intellectual Property Organisation data that shows that up to September 2018, 45,379 patent applications were filed in India. Of these, 27% were granted, 65% were withdrawn or abandoned by the applicants and 7% were rejected.

Since 2013, the Indian government has pursued compulsory licenses that allow local manufacturers to produce the generic version of a medicine by paying royalties for three cancer drugs—two for breast cancer and one for leukemia. The application of section 3(d) in India has inspired activists in South Africa and Thailand to push for stricter patent criteria and patent opposition.

 

Not all breast cancers are alike – Cancers that test positive for particular proteins (like this HER2 positive breast cancer image) often are more responsive from targeted treatment

 

COMPULSORY LICENSES

Compulsory licensing, which helped bring down the cost of antiretrovirals by up to 90% in the global South, is now a tool used by even high-income countries to manage drug prices. Recently, the Netherlands has been considering using compulsory licenses to bring down the costs of health care, a policy that has attracted US censure.

Pharmaceutical companies are also involved in making drugs accessible in low-and-middle-income countries. Recognising that developing countries face significant resource constraints and access barriers, German pharmaceutical company Merck has adopted a policy of not filing or enforcing patent application in a large majority of developing countries, says Isabel Klinnert, Director Global Government Affairs, Merck KGaA.

In countries where Merck files patents, they commit to enhancing data sharing with researchers and improving public access to clinical trial information. For NCDs in developing countries, it supports voluntary licensing agreements to improve access. “Our R&D partnerships are designed to address diseases impacting developing countries and to help advance our partners’ R&D and manufacturing capacity,” says Klinnert.

Countries can negotiate with companies directly to bring down prices of drugs by ensuring bulk orders. The approach especially makes sense for countries like Nigeria, which are seen as less attractive markets for pharmaceutical companies due to their LMIC status. “One way to mitigate this challenge is through volume guarantee for the production of NCD drugs, which would make Nigeria attractive for Big Pharma and NCD drugs affordable for sufferers,” says Ifeanyi M Nsofor, CEO of EpiAFRIC and policy director at Nigeria Health Watch.

 

GLOBAL ILLS NEED GLOBAL TREATMENT

The covid-19 pandemic has demonstrated why efforts to improve access to drugs and vaccines need to move beyond national borders. As vaccines bring the promise of an end to national lockdowns, existing global inequalities are evident for all to see, with developed nations often buying far more vaccines than their populations require, while many LMIC countries have yet to begin vaccination programmes.

“It is clear that the covid-19 pandemic has destabilised the great advances made in global health in the past decades, while showing how deeply the structural issues preventing access to medicine really run,” says Martinez of the Access to Medicine Index. “Our hope is that the global community—including the public and private sector—will see this as a wake-up call for bringing fair and equitable access to medicine to everyone.” •

 

TEXT Swagata Yadavar — ILLUSTRATION Luke Best —  PHOTO Myriam Zilles

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