I. Slovakia – Re-Export Ban
As of 1 January 2017, only marketing authorization holder (MAH) of a medicinal product or a distributor with a prior written consent from such MAH can legally export categorized medicines outside Slovakia. It is entirely up to the MAH whether he gives or refuses such consent, the distributor has not legal right to such a consent. Absence of consent means that the product cannot be legally exported.
Categorized medicines are medicinal products on a list put together by the Slovak Ministry of Health and essentially include all medicines reimbursed by Slovak health-insurers. There are no further conditions to appear on the list, i.e. there may be excessive quantities of the medicine on the Slovak market, the medicine may lack history of unavailability and it may even have a perfect substitute, but it will still appear on the list.
Ever since the ban adoption, there have been doubts about its EU law compliance. While the Slovak authorities have undoubtedly pursued an extremely important goal – safeguarding medicines for Slovak patients by preventing their parallel export outside Slovakia – there has been a fear that they may have gone beyond what is necessary and that the ban is disproportional. The ban is clearly a provision constituting a measure having quantitative restriction on intra-EU trade in the meaning of Articles 34 and 35 TFEU and may be disproportionate, i.e. inappropriate and unnecessary contrary to the Article 36 TFEU.
The EU Commission in its Paper on the obligation of continuous supply to tackle the problem of shortages of medicinesfrom 25 May 2018 noted in relation to lists of medicines banned from export that (a) such lists may only apply to medicines for which a shortage is likely or certain, such as those medicines where the volume available does not meet current needs of patients in the Member State; (b) such lists must take into account the availability of alternative treatments in the Member State; (c) such lists are revised on a regular basis taking into account the latest occurrences or risks of shortages of medicines for public health; and (d) the decision to put a medicine on the list are open to be contested before the relevant administrative bodies or courts of justice. The Slovak ban fulfills none of these conditions.
The Slovak export ban was challenged by re-exporters before the EU Commission which stated that while the ban is infringing the EU law, it will use its discretion not to open infringement proceedings and leave it up to re-exporters to seek damages against Slovakia before Slovak courts. Several re-exporters did exactly that, i.e. they have filed actions against Slovakia before Slovak courts and it will be interesting to watch to what success.
According to Slovak official records, MAHs have given 73 consents with re-exports to distributors since 1 January 2017. It is clear that there have been many more illegal re-exports of medicines without the consent from MAHs and that the ban has not lived up to its promise. Allegedly, the Slovak healthcare authorities lack sufficient data due to their limited cooperation with Slovak customs and therefore cannot effectively prevent illegal exports.
II. Czechia – Proposed Introduction of Re-Export Ban
A) Current Czech Restriction on Re-Exports
Current Czech Act on Medicinal Products allows the Ministry of Health to put medicines in risk of unavailability on a list of medicinal products. Once a medicine is on this list, its re-export intention must be in advance reported by distributors to the State Institute of Drug control. The Ministry of Health may then decide that the export of such medicine on the list is prohibited. This two-step procedure has been criticized by some as too complicated and time-consuming and the Ministry of Health has bypassed it by issuing general pre-emptive measures prohibiting medicines exports with immediate effect. While welcomed by medicines producers, the pre-emptive measures are a subject of controversy for their lack of legal basis.
B) Intended Czech Restriction of Re-Exports
The Ministry of Health considers the current Czech restrictions as insufficient and is working on its amendment that will copy the Slovak model. As in Slovakia, Czech re-exports of medicines reimbursed by Czech health insurers will only be legal if done by MAHs or by distributors with their prior, explicit and written consents. Given the similarity between the Czech and Slovak bans, all controversies connected with the Slovak ban would also apply to the Czech.
Slovakia, to secure medicines for its patients, adopted a re-export ban which gives MAHs an absolute control over legal re-exports outside Slovakia. Given the fact that it applies essentially to all medicines reimbursed by Slovak health-insurers without regard to the quantity of such medicines available on the Slovak market, history of shortages, their substitutes and does not provide any recourse to state authorities or courts in case of MAHs non-reaction or refusal, there is a risk of disproportionality and non-compliance with EU law, in particular with Articles 34, 35 and 36 TFEU. The Slovak ban is currently challenged before Slovak courts and we will closely monitor its outcomes.
The Slovak ban seems to be so attractive that the Czech Ministry of Health intends to adopt it into Czech legal system, regardless of its controversies.