Medicine shortages have been a growing issue across the European Union, especially for essential medicines, such as cytostatic drugs or medicines for chronic diseases, that are intended to meet priority health needs. While shortages may have multiple reasons, commercial withdrawals are attracting more attention and interest, especially in some Central and Eastern European countries. Medicines may be withdrawn from markets because of risks to patients, but also because of commercial reasons. Drug withdrawals for commercial or financial reasons are actually more frequent than those for concerns about safety or efficacy, though they are insufficiently analyzed.
Commercial considerations of pharmaceutical companies operating in Romania resulted, between 2016 and 2021, in thousands of drug notifications for withdrawals. Thus, 70% of the current total drug discontinuity notifications monitored by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) are for commercial reasons and almost 20% are the only product for a common international name. Meanwhile, almost 10% of the notifications for temporary commercial withdrawals are prolonged indefinitely – no return data to the market is given and more than 30% ceased to be available for the Romanian patients, being permanently withdrawn from the Romanian market for commercial reasons.
Romania has faced critical shortages over the past years, such as immunoglobulins and MMR vaccine (spring 2017) and in some cases, chronic patients required the Romanian Ombudsman’s intervention, e.g Oxacarbazepine, medication used to treat epilepsy or Levothyroxine, a medicine used to treat hypothyroidism. Meanwhile, the crisis of some standard first-line chemotherapy medicines (e.g cisplatin, bleomycin, etoposide etc) continues to be at risk of deepening in Romania. In all these cases, parallel distributors, not only that they have voluntarily stopped exports but they have found available medicines in other Central-Eastern EU countries and donated or parallel imported them, filling thus the gap created by these shortages, at lower or the same prices with the original products.
In many cases, commercial withdrawals could be seen as “fancy dresses” for possible anti-competitive behavior, consisting in limiting and disrupting the supply of the Romanian market with certain medicines (especially off-patent medicines or single product per INN), with the aim of eliminating the Romanian claw-back tax and obtaining a more favorable fiscal framework and, implicitly, of improving the profit margins.
For example, the discontinuity in the supply of immunoglobulin was generated by the withdrawal from the market of producers who were covering over 80 % of the immunoglobulin needs. Besides removing the claw-back for 3 years from vaccines and plasma-based drugs to counter the crisis and increasing their prices, in March 2018, Romania has officially requested help from EU member states and NATO in the immunoglobulin crisis, through the civil protection mechanism. As a consequence, the Competition Council has launched an investigation into a possible anti-competitive behavior, in Romania, Belgium and Italy.
In 2017, the marketing authorization holder for the antiepileptic drugs based on oxacarbazepine, has permanently withdrawn its products from the Romanian market, for commercial reasons, although no therapeutic alternatives were available on the market. Once the products have been parallel imported in 2018, the MAH decided to return to the market, under the same commercial conditions which generated the withdrawal.
For more on this, see the Article outlining this case here.