Shelling, bureaucracy, and medicine: why the risk of drug shortages is rising in Ukraine
2 February 20:19
The war has made Ukraine’s drug supply chain vulnerable not only due to shelling and logistical challenges, but also because of regulatory procedures that, in a crisis, can become a critical barrier to patients’ access to treatment.
This is according to the business community of the European Business Association (EBA), which is calling on the government to implement anti-crisis changes to procedures for confirming that drug production complies with GMP standards, reports "Komersant Ukrainian".
Strikes on Warehouses and Loss of “Safety Stock”
Following rocket attacks that destroyed pharmaceutical distributors’ warehouses along with drug reserves, companies are reporting significant risks of supply disruptions.
According to estimates from open sources and statements by affected companies, a single attack could have destroyed up to 20% of the country’s monthly drug supply. These reserves served as a buffer, allowing the market to function despite lengthy regulatory procedures.
Once lost, any delay in importing new shipments immediately translates into a risk of shortages.
GMP as a “bottleneck”
Businesses cite the GMP (Good Manufacturing Practice) certification process as a key problem—a mandatory prerequisite for importing and placing medicines on the market in Ukraine.
According to the companies, this procedure:
- remains excessively bureaucratic;
- has unpredictable processing times;
- makes it impossible to import new batches without obtaining the relevant conclusion.
Given the institutional changes and the State Service of Ukraine on Medicines and Drugs Control’s application of procedures, the timing of GMP document issuance is, according to the business community, difficult to predict, which creates additional risks to the continuity of supply.
Patients at risk
The combination of destroyed warehouses and delays in regulatory procedures directly affects patients’ access to treatment.
The most vulnerable are people with:
- cancer,
- cardiovascular diseases,
- diabetes,
- orphan (rare) diseases,
where interrupting treatment can have critical consequences, and alternatives to medications often simply do not exist.
Experience from the start of the war
The business sector notes that at the start of the full-scale invasion, Ukraine had already implemented simplified procedures for importing medicines. These measures ensured uninterrupted supply without compromising quality and safety standards.
According to information from open sources, during the period when these simplifications were in effect, there were no public reports of drug quality issues that could be attributed to the lack of GMP re-certification in Ukraine.
In the context of European integration, the EBA proposes the recognition of GMP certificates issued by regulators in countries with strict control systems—specifically based on international registries:
- EudraGMP,
- FDA,
- Swissmedic,
- MHRA,
or based on certified copies of such certificates without a re-certification procedure in Ukraine.
According to the business community, this will:
- reduce duplication of regulatory procedures;
- serve as a crisis-response solution during wartime;
- help prevent drug shortages;
- bring Ukraine closer to the practice of mutual or automatic GMP recognition, which is common in the EU.
Call to the government
That is why the European Business Association calls on government authorities to adopt urgent anti-crisis measures that will mitigate the risks of supply disruptions and ensure the continuous availability of essential medicines for patients.
