Click to expand Image Darya Semyonova, 23, standing in a single-person picket outside the Russian Health Ministry, holding a sign saying “I want to live.” November 29, 2019. Source: Olga Shilina/Facebook with permission of the subject

(Moscow) – Thousands of people in Russia with cystic fibrosis could face potentially life-threatening risks to their health as a consequence of recent government policies forcing patients to switch to generic drugs, Human Rights Watch said today.

Activists and doctors are calling on the government to reverse the policy, which affects many patients with various medical conditions. The generic drugs are cheaper, but some doctors have said their effectiveness is not clear, that they may not be suitable for all patients, and that they may have severe negative side effects for some patients.

“The Russian government needs to swiftly reverse this regressive policy, which restricts access to life-saving medication for people living with cystic fibrosis,” said Rachel Denber, deputy Europe and Central Asia director at Human Rights Watch. “The drug policy is compromising people’s right to health.”

More than 300,000 people have signed a petition calling for the government to restore patients’ access to the drugs that have been proven effective for cystic fibrosis.

Cystic fibrosis is a rare genetic condition that produces thick mucus linings in the lungs, causing breathing difficulties and a high risk of fatal lung infections. It requires lifelong daily treatment. Over the past 50 years, there have been remarkable improvements in health outcomes for people with cystic fibrosis, which was once fatal in infants and young children. In 1996, life expectancy for a child born in Russia with cystic fibrosis was 14 years. Although estimates vary, life expectancy now for people living with the condition is much higher in Russia, but is still estimated to be considerably shorter than the mid-40s or above in European Union countries. Behind these gains has been improved access to care.

Many people diagnosed with cystic fibrosis need to take antibiotics on a regular basis, or their breathing can be fatally compromised.

According to available official data, as of 2014, the prevalence of cystic fibrosis in Russia was 1 per every 10,000 births. The vast majority of the nearly 4,000 people living with cystic fibrosis in Russia are children.

A 2014 law introduced the policy of “import substitution” aimed at reducing medication costs and supporting Russian pharmaceutical companies. In the following years, the government took several steps to replace foreign medications with generic drugs that are produced more cheaply, mostly in Russia. The government reduced its procurement price, which forced many foreign suppliers out of the Russian market. Russian media reported that in the first half of 2019, more than 25 percent of tenders for public procurement of medications failed due to bid conditions that included capping a potential contract’s price.

The situation for people living with cystic fibrosis deteriorated drastically in November 2019, when two foreign suppliers of key antibiotics for cystic fibrosis left the Russian market.

Reports in the Russian media about people with cystic fibrosis who have since died include accounts by doctors and parents of how generic drugs triggered severe side effects or otherwise caused the person’s condition to deteriorate, perhaps even contributing to their death. One doctor said that when her patient switched back to her brand name prescription because the generic drug was not working for her, her body rejected the original drug.

On February 19, 2020, Russian healthcare authorities reported that they did not find any substantial differences between brand name medicines for cystic fibrosis and generics.

On February 25, a group of Russian doctors specializing in cystic fibrosis published an open letter to Prime Minister Mikhail Mishustin, saying that the 2014 law has had “catastrophic” consequences. They said that the authorities were registering large numbers of generics for cystic fibrosis treatment based only on their chemical composition, without first testing them to determine whether they were as effective as the brand name drugs. They urged the authorities to approve drugs that have been widely used abroad that address the underlying cause of the disease rather than only its symptoms.

On February 29, International Rare Disease Day, an activist living with cystic fibrosis, Taisiya Sheremet, started the #ДайтеМнеДышать (Let me breathe) campaign to demand access to medication with proven effectiveness. Popular Instagram bloggers and activists supported this campaign by taking pictures of themselves with a plastic bag wrapped over their heads to illustrate what cystic fibrosis symptoms feel like.

“Putting a plastic bag over one’s head is also a popular method of torture and murder,” Sheremet told the media. “This is exactly what our government is doing [to us].”

On March 4, people with cystic fibrosis and their relatives held a series of single-person protests outside the Health Ministry building in central Moscow demanding access to medicines with proven effectiveness.

People living with other conditions have also suffered consequences from the “import substitution” policy.

In February, a group of pediatric oncologists published an open letter to the Health Ministry calling for access to brand name medications and for expedited registration of cancer treatment drugs that have been proven effective. In response, Prime Minister Mishustin lifted restrictions on the purchase of foreign medications for cancer patients.

On March 2, doctors for cystic fibrosis, diabetes, and cancer patients reiterated their concerns during a roundtable discussion on the subject at the Public Chamber, a consultative council that provides public feedback to the government on a range of issues.

Russia is a party to multiple human rights treaties, including the International Covenant on Economic, Social and Cultural Rights; the European Social Charter; the Convention on the Rights of the Child; and the Convention on the Rights of Persons with Disabilities, all of which guarantee the right to the highest attainable standard of health.

Governments should ensure that patients have access to appropriate and quality treatment based on proper medical assessment and on the basis of free and informed consent, and should not undermine the right to health by supporting national manufacturers of generic medication that is not of the same quality. Downgrading the availability, accessibility, and quality of treatment for cystic fibrosis patients is a retrogressive measure, which in general in relation to the right to health is not permissible.

The United Nations Committee on the Rights of the Child has reminded countries that as parties to the Child Rights Convention they have “to place children’s best interests at the centre of all decisions affecting their health and development, including the allocation of resources, and the development and implementation of policies and interventions that affect the underlying determinants of their health.” The committee explicitly underlined that the best interests of the child should guide treatment options, superseding economic considerations where feasible.

What is at stake is not a right of access to name brand medicines over generic, which may well be more affordable, but of access to appropriate medicine of good quality irrespective of whether the drugs are brand names or generic, Human Rights Watch said.

The former UN special rapporteur on the right to health, Paul Hunt, has said that the right to health requires providing individuals and communities with an opportunity to participate in decision-making that bears upon their health. He also said that “reliable information about medicines must be accessible to patients and health professionals so they can take well-informed decisions and use medicines safely.” The Russian government has an obligation to regulate and ensure that generic drugs are safe and effective substitutes for foreign medicines and that if generic alternatives are not effective for some patients, patients are able to access safe alternate drugs.

“Government support of national pharmaceutical companies cannot come at the cost of the right to health, and of suffering, and even premature deaths of people, like those living with cystic fibrosis,” Denber said. “The lives of people with cystic fibrosis depend on their access to effective medications. The government needs to reverse its policy now.”