The Constitutional Court approved the possibility of compulsory licensing of essential medicines. Thousands of Russian patients, most of them children and teenagers, have been given hope of a normal life.
This story began in June 2023, when a new drug for cystic fibrosis was registered in our country. It is produced by a well-known American biopharmaceutical company. This drug is very effective – suffice it to say that, according to Ministry of Health calculations, it can increase the life expectancy of patients by two to three times, up to 80 years. One could only rejoice in the victory of progress and modern technology, were it not for the astronomical price. It costs one patient about $260,000 annually, but treatment must continue for life.
In Russia, more than four thousand people suffer from cystic fibrosis, including 1,960 children and adolescents (under 18 years). A new drug prescription is indicated for 90 percent of patients. On a national level, this is a huge amount of money, and of course, we really want to reduce expenses. After all, patients with other orphan (rare) diseases also require expensive treatment. And the budget possibilities are not limitless. In 2024, a generic version (clone) of an American drug produced in Argentina was registered in our country. Practice has shown its equal effectiveness. But the generic type costs 60 percent less. And the supplier company issued the so-called compulsory license – the right to use someone else’s patent without the consent of the copyright holder.
We’re treading on thin ice here. A patent protects the developer’s rights, and can only be restricted for a very serious reason. In this case, this is an opportunity to save many patients. Living with cystic fibrosis is really painful. Due to hereditary diseases, thick mucus clogs the lungs, patients cough continuously, suffocate and eventually die. Without recent treatment – very young. What weighs in the hypothetical balance: their lives or patent protection, which ensures the profit of the manufacturer? The question is, of course, rhetorical.
Moreover, compulsory licensing of medicines is not a Russian invention at all. It was used in one form or another in Canada, Great Britain and India. The laws of Brazil, South Africa and other countries provide for this possibility. In 2001, the Doha Declaration was adopted, which stipulates the right of countries to compulsory licensing of medicines. It stipulates, in particular, that the protection of patent rights cannot be done at the expense of public health. In this case, it is necessary to respect the interests of the copyright holder, who should receive a percentage of the profits of the company that has obtained a temporary license for his medicine.
Americans will also receive this compensation. After all, creating an innovative drug requires many years of work and billions of dollars in investments, with the risk of failure. Naturally, the company strives to recover costs and make a profit. This means that it is necessary to find and maintain a careful balance between the interests of the manufacturer and society. Obviously, in this case, the very high price of the drug limits the circle of patients who will have the opportunity to be treated.
The Constitutional Court’s decision hardly delighted the American copyright holder. But patients will thank the creators of this unique medicine anyway. I would like to believe that our drug manufacturers, who prefer not to take risks and produce generic drugs whose patent protection has expired, will also begin to invest in the development of innovative drugs.
The opinions of columnists may not match those of editors