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Why is it so hard to get needed medicines in Russia? A gastroenterologist explains Russia's convoluted pharmaceutical market, as federal officials adopt new ‘counter-sanctions’

Source: Meduza

This week, Russian lawmakers adopted a first and second reading of legislation allowing the government to impose sweeping new “counter-sanctions” on hostile foreign states. The bill brings Moscow a step closer to banning the import of a whole series of vital medicines. Meduza asked gastroenterologist Alexey Paramonov, the director of the Rassvet Clinic, to explain Russia’s regular shortages of important pharmaceuticals.

Why do different medicines disappear from the shelves?

Interruptions in drug supplies are indeed routine in Russia. For instance, patients with chronic ailments run into the same problem: the drug they have carefully selected vanishes from pharmacies, and with their doctors they suddenly have to choose a substitute. If you're lucky, the same drug is registered in Russia under several brand names. (In these cases, the replacement is relatively painless.)

But consider a recent case: mesalamine supplies started vanishing from pharmacies, one after another. Many patients with ulcerative colitis, Crohn's disease, and recurrent diverticulitis need this medication, and delayed treatment risks exacerbation and could trigger the need for the next stage of therapy, which involves the use of more powerful and more dangerous drugs.

The brand-name drugs containing mesalamine are only partially replaceable. This winter, patients and doctors found themselves in a situation where both the expensive brand-name mesalamine drugs and the cheap Indian generics both gradually became unavailable. Why? It turns out that it has to do with the state’s protection of patients’ interests. The state puts important drugs on the list of vital and key medications and determines the maximum permissible price for them.

This protection has two consequences: First, the process of price determination is periodically repeated, and it takes some time for the relevant parties to reach an agreement. The state wants the drugs to be cheap, in part so they can be purchased for state hospitals and people on welfare. The manufacturers defend their own interests, and the government’s set price has to be high enough to keep them on the Russian market. While negotiations are happening (and there are separate talks for each [drug] form and dosage), the medicine vanishes from pharmacies.

Second, when bringing a drug to market, the manufacturer counts on selling a certain volume at the price set by the state. If the state lowers the price, the company might simply stop shipping it to Russia, should the new sales cease to cover the costs.

And there’s another factor: The Industry and Trade Ministry recently started auditing foreign manufacturers to ensure that their production processes comply with international GMPs [good manufacturing practices]. Colleagues from pharmaceutical companies say there have been cases where a major production facility registered as Swiss turned out to be in India and did not meet any of the regulatory standards. After being audited, these shady manufacturers have to suspend deliveries until they’ve brought their plants into compliance with the regulators’ demands.

Why has it become so hard to get imported vaccines?

It’s a slightly different story here. For instance, Priorix, an imported live vaccine against measles, mumps, and rubella, is no longer being supplied by pharmaceutical companies and pharmacies. The shelf life of the stocks that remain in a few clinics expires in June, and nobody knows when the next delivery will be.

Well-informed colleagues from pharmaceutical companies say there are several reasons for this: the low maximum price set by the list of vital and key medications, and also, most importantly, the fact that the incidence of measles is growing in Europe, so European producers are supplying the vaccine primarily to EU countries. The vaccine production process does not make it possible to ramp up deliveries quickly, so we get shortages and the vaccine goes primarily to the countries where it’s manufactured. Russia itself does not produce a trivalent vaccine, and by mid-May our distributors had only one monovalent vaccine for these diseases: a rubella vaccine. Specialists don’t think much of it, finding that it provides only a poor level of immunity and frequently has side effects.

The flow of vaccines to the market also depends on the World Health Organization, which recently decided to use an inactivated (dead) polio vaccine not only in developed countries but also in developing countries. Demand for this type of vaccine rocketed, and Russia stopped receiving deliveries of the monovalent vaccine Poliorix, while deliveries of Pentaxim (a pentavalent vaccine effective against polio) fell sharply. Presently, Infanrix Hexa (which also contains a component effective against hepatitis B) is making it possible to remedy the situation. But these kinds of substitutions make it difficult to plan vaccinations, as patients are forced to switch from one kind of vaccine to another and to substitute monovalent vaccines for polyvalent vaccines.

Some clinics occasionally receive vaccines that are in short supply, but only in limited quantities, and there is not enough for everyone. The state takes a lot of vaccines, and private companies get what’s left. Just who gets it depends on the relationships between clinics and drug distributors. Personal relations and the clinic's importance to the distributor as a good customer play an important role. In the market, there are also intermediary pharmacies that get priority supplies of vaccines and sell them to clinics at retail prices marked up by around 30 percent.

Why are some important drugs not even registered in Russia?

Mostly for economic reasons. For instance, the United States produces the laxative linaclotide, which has no counterpart in Russia and is more effective than anything else for treating irritable bowel syndrome with constipation. Millions of patients in our country need it, but this hasn’t been enough to convince the manufacturer to register it here.

Registration is a process that takes at least nine months, and it necessitates carrying out research to confirm the drug's effectiveness and safety in Russia or in another state withtin the Customs Union — even if such research has already been carried out elsewhere. One specialist at a pharmaceutical company estimates that the minimum registration cost starts around $1 million. This is next to nothing for a U.S. company, but the producer also evaluates the market, tries to predict whether the state will buy the drug, and decides on the basis of a combination of factors whether competing for Russia’s market is worth it.

Some drugs are known to be unprofitable for manufacturers but are nevertheless vital to patients. One such drug is dantrolene, a treatment for malignant hyperthermia that is not registered in Russia. This drug is a lifeline when treating very dangerous complications arising after anesthesia or the use of certain psychotropic drugs. But since malignant hyperthermia occurs rarely and is unpredictable, hospitals have to keep this drug “just in case,” knowing that much of the batch will never be used. But each ampoule put to use is a life saved. Manufacturing drugs, meanwhile, is a business, and producers are under no obligation to act as charities, let alone in a foreign country. But we see no sign that the state has any desire to solve this problem by spending the money needed to save these patients.

If the state provides medications, why are the drugs often changed or delayed?

The state buys drugs on the basis of International Nonproprietary Names (INN). It’s perfectly legal to be given Russian-produced bisoprolol at a health center, even if you’re accustomed to taking imported Concor (whose INN is “bisoprolol”). This is true, even though it might not be as helpful.

In addition, the state sometimes messes up the necessary drug quantities needed, when planning purchases. So there might not be enough bisoprolol in a certain region, and pharmacies have to replace it with its closest available counterpart — maybe metoprolol. But this is by no means the same thing. This is why many patients entitled to subsidized pharmaceuticals prefer to avoid substitutions and buy their missing drugs with their own money.

What can Russians do if a needed drug isn’t available domestically?

Russians can buy medications abroad for personal use, but in many countries they’ll need a prescription. If sanctions are enforced and specific drugs lose their Russian registration, Russian doctors will lose the right to prescribe these medications, and Russians’ only option would be visiting a foreign physician.

There is also another, even more complicated alternative: A medical commission can prescribe an unregistered drug, after which a patient has to obtain a formal permit. In practice, the process is so complicated that it only really works in a few major cities with large administrative resources.

What’s so special about American drugs?

Major world pharmaceutical manufacturers are all connected to the United States in one way or another; it’s the world’s biggest market for medications. Even if a company is formally registered in Belgium or Switzerland, often most of its business is in the United States. Also, there are high-tech companies in the U.S. that aren’t yet operating internationally, but they’re leading the world in biotechnology and the development of drugs to treat cancers and autoimmune diseases. Russian medical professionals are interested in these enterprises, but these companies are not interested in Russia.

Russians shouldn't expect some friendly country to come along and fill the vacuum if the American pharmaceuticals leave. Alas, that’s not how it works. Replace Parmesan with hard cheeses from Argentina, and only foodies can tell the difference. In the pharmaceutical industry, each company specializes in a specific field, and all advanced technologies belong to just one or two companies and they’re protected by patents. Russia would have second- and third-tier companies specializing in generics, but it’s already got plenty of that.

What will hospitals do if the needed drugs simply disappear?

They’ll use whatever they’ve got. Something similar happened in 1999, when drugs weren’t banned, but hospitals could no longer afford them. The hospital where I was working at the time treated patients with powders made from kaolin and belladonna.

State hospitals have absolutely no room to maneuver here; their purchasing is all centralized. Russia still has very few private hospitals. How will state hospitals manage this situation? They’ll either have to violate patients’ interests or break the law.

The latest news from the State Duma [where language identifying specific economic spheres to target in counter-sanctions was removed from the legislation’s first reading] is encouraging, and we probably won’t have to face this dilemma. All the doctors and medical care executives with whom I’ve discussed this issue say they can’t believe the counter-sanctions would affect such a delicate sphere as healthcare.