Magazine
12:00 3 October 2019
Post by: WBJ

Feature/ Pharma - A cure for the drug crisis

Pharmacists, doctors and, above all, patients are warning that there is a deepening shortage of medication on the market. Millions of patients are affected, and the situation is not getting any better. Who is to blame and is there a solution in sight? By Sergiusz Prokurat

Feature/ Pharma - A cure for the drug crisis

The shortage of prescription drugs in Polish pharmacies has become a common occurrence. Patients come to a pharmacy with a prescription, but the medicine is missing. Sometimes a substitute can be proposed, but if there isn’t one? It’s quite normal to hear: “We’re sorry – there is no such medication and we have nowhere to order it from. When is it going to be available? We don’t know.”

Which medicines are missing? Mainly those for chronic diseases: diabetes, hypertension, thyroid diseases, asthma and allergies. Some of these are life-saving drugs and are crucial for everyday life. Oncological and neurological drugs are also beginning to be in shortage. To make matters worse, the list of medicines at risk of non-availability is constantly growing: in January 2017, 173 drugs were in short supply, in November 2017 – 197, in May 2018 – 208, in September 2018 – 266, in November 2018 – 311, in January 2019 it was up to as many as 338 items. And more and more items appear on the list.

The list is created on the basis of pharmacies’ reports of wholesalers’ refusal to provide a particular drug, and as such can be quite inaccurate. Although 60 percent of medicines from the list are not available in more than half of pharmacies, they may still be available somewhere in Poland. There may be as many as 500 medications that are hard to find in Poland. At the end of July 2018, the database included over 16.6 million reports of refusal to process orders for medications – currently it is many more. What should a patient do if the medicine they need is not available in the pharmacy?

The Ministry of Health claims that it is working to ensure the best availability of medicines. In July 2019, a helpline was launched which was to help everyone find out where their medicine is available. On the first day of operation, the helpline recorded as many as 20,000 calls. The ministry claims that it is operated by 30 consultants. I make a call. Once connected, a voice that sounds like something from the underworld announces that I have connected to the patient helpline and – after three wait signals – the same voice announces that all consultants are busy, suggesting that I call again at another time. Even if I did finally get through, I would probably hear that the medicine is available in a pharmacy 400 km away and I have to hurry because someone might snag it before I get there. The helpline is little more than a smoke screen. Patients can get the same information on websites such as KtoMaLek.pl and GdziePoLek.pl.

In 2009, patients paid PLN 10.24 for one 40 mg dose of Clexane on prescription; the National Health Fund paid an additional PLN 107.61. The final price without prescription was PLN 117.85.
Currently, in 2019, patients pay PLN 35.49 for the drug on prescription, while the remaining PLN 77.13 is paid by the National Health Fund. The recommended market price in the UK is £56.50 (PLN 280). In 2009 there have already been problems with its availability in pharmacies.


WHO’S TO BLAME?

While desperate patients make pilgrimages from city to city in search of vital medication, the hunt for the guilty party is still in progress. On the one hand, the Ministry of Health pretends not to see the extent of the drug crisis, while on the other hand, it is eager to point fingers: pharmaceutical companies or suppliers of active substances from China; the EU serialization requirement, i.e. the obligation to place codes and special stickers on medication packaging in order to be able to verify the authenticity of each package before it is admitted to trading; and above all, the “medicine mafia,” which exports medicines from Poland to countries where they are sold at a higher price. Meanwhile, the crisis associated with the drug shortage has not affected hospital wards, and this means that the medicines are in fact supplied by manufacturers. If the medications are in fact being produced, where do they go?

SUPPLY AND DEMAND

Poland currently has some of the cheapest medicines in Europe. Polish regulations on the drug market set rigid prices for drugs and limits on manufacturers’ margins. The state negotiates with drug manufacturers over which products should go on the special list of reimbursed medicines. When a particular medication is put on the list, the state covers most of its price, guaranteeing the manufacturers some profit. Getting on this list is a question of “to be or not to be” for many medications, particularly those that are so expensive that patients might never be able to afford them. The list changes every two months, which does not always serve stabilization, but it allows patients access to cheap medication. The price of reimbursed drugs is influenced by criteria such as the average salary. Poland has one of the lowest in the EU, so the negotiated prices are also lower than in other countries. For example, Clexane, an anti-coagulantmedicine, costs about PLN 120 in Poland, while in Germany it costs about PLN 300.

These differences in drug prices are the main reason drugs are being exported and sold abroad at much higher prices. According to the calculations of the market controlling institution (Chief Pharmaceutical Inspectorate), every third medication may be exported from Poland, and according to research companies, one out of ten pharmacies ships drugs abroad. Polish reimbursed medicines go mainly to Germany and the UK, and the value of their illegal export is estimated at over PLN 2 billion.

SHADY BUSINESS

The ministry declared the export of medications illegal and its originators have been called the “medicine mafia.” This has led to the creation of a list of medicines that cannot leave the country without the Chief Pharmaceutical Inspectorate’s approval. Within six years, it has initiated proceedings against 600 pharmacies and wholesalers. However, after several years of this fight against the “medicine mafia,” not a single financial penalty has been imposed. In the case of the record-holding pharmacist, who funneled out medicines worth PLN 45 million, the court dismissed the case, citing low social harm.

The scale of this shady business has become so large that the government has taken steps to tighten the law even further. Since June 6, 2019, the export of medicines abroad is punishable by up to ten years in prison for exporting a drug that is on the “shortage list.” Legal changes also mean more efficient inspections and audits. The inspectors can be supported by the police, the border guard and even the Internal Security Agency. The government is pulling out all the stops to fight this phenomenon. However, what we call “mafia” in Poland, in the West is a completely legal practice known as parallel sales.

LOOKING FOR THE ANTIDOTE

What’s next? The opposition party, seeing the sluggishness of the government, has proposed intervention buy-ins from abroad. This would cost unimaginable amounts of money. After all, Poland would buy medicinal products at Western rates. An antidote could be a common EU policy and price setting, but Poland is obstructing this idea because it could mean an increase in domestic medicine prices. It would be political suicide for the ruling party. It would then be necessary to use EU subsidies to level out the disparities. Another option would be to simply raise medicine prices to levels similar to those in ships them abroadneighboring countries, while increasing the amounts of reimbursement. Patients would not notice any changes and medicines would be more available. However, it would mean delving into the budget and could mean tax increases.

Each of these remedies involves intervention from state institutions and maintains a price regulation system. The government is playing for time, because it expects the situation to straighten itself out once e-prescriptions are fully implemented. Their introduction should facilitate control over all entities involved in the pharmaceutical trade. The act has already been signed by the President and IT preparations are ongoing. Some clinics are already issuing prescriptions that consist of a four-digit code that is to be used with the patient’s Social Security number (PESEL). The obligation to issue prescriptions in this form will be in force from 2020.

But whether e-prescriptions will solve the drug shortage problem is doubtful. As long as there is a price disparity between countries in Europe, medications will continue to be exported. Nearly a century ago, in 1922, Ludwig von Mises wrote in his book Socialism that “Speculation has a role to play – it predicts and adjusts supply and demand in time and space. This sad truth will be valid as long as prices are set by the governments.”


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