Filenews 24 November 2022 - by Marilena Panayi
Around 800 different drugs, several of which are widely used and some unique, are at risk of withdrawal from the Cypriot market. The reason is the procedures for their introduction and a forgotten provision of the legislation which has been sent to the Legal Service for study and opinion, without, however, yet giving the relevant answer to the Pharmaceutical Services, which are the competent Authority.
The problem arose a year ago when pharmaceutical officers identified that the legislation provides that the issuing of invoices for payment of medicines must be done only by the holder of a wholesale distribution license of each preparation and not by anyone else. Simply put, the company/holder of a wholesale distribution license that exports the medicines to Cyprus must issue the invoices received by the importers.
In practice, this creates for Cyprus a huge gap which mainly concerns preparations imported from Greece (and some other countries) where the companies holding marketing authorization (manufacturers or official distributors) that issue invoices for Cypriot importers do not have the wholesale distribution license but, under contracts, cooperate under contracts with other licensed entities from which they receive the quantities ordered by Cypriot importers.
The problem, although purely technical and procedural, has caused great concern both to the importers of medicines and to the Pharmaceutical Services of the Ministry of Health, since if this is indeed provided for by law, the way in which medicines are imported into Cyprus, as applied to date, constitutes illegality which must be lifted. Thus, the Pharmaceutical Services, as the competent Authority, approached the Legal Service asking for an opinion on whether the procedure followed today actually conflicts with the relevant legislation.
"As the Association of Pharmaceutical Companies of Cyprus, we are in constant contact with the Pharmaceutical Services and from the investigation we did we have found that the problem concerns around 700-800 formulations which, if the issue is not settled, our members will be forced to withdraw from the Cypriot market, with all that this of course entails", the president of SFEK told "F", Christos Hadjipanagis, adding that the Association, "is now waiting for the opinion of the Legal Service with anxiety since the continuity will depend on it".
The president of the organized patients, Marios Kouloumas, expressed anxiety, speaking to "F", pointing out that "800 formulations are almost 1/3 of the prescription of Cyprus and it is not possible for purely procedural reasons for Cypriot patients to lose them". The president of the OSAK argued that "the matter must be settled without any delay, whatever the opinion of the Legal Service and patients and doctors should not be left without the medicines they need for even one day. These are front-line formulations that we do not have the right to deprive our patients."
However, on the part of the Pharmaceutical Services, there seems to be readiness to deal with the issue and settle it as soon as possible, while both drug importers and organized patients have received assurances that decisions will be taken that will not allow the withdrawal of medicines from the Cypriot market.
Investigation also carried out in the rest of the EU
According to information provided by "F", both on the part of the Pharmaceutical Services and on the part of the importers of medicines, an investigation was carried out in the previous period for what is happening in the other Member States of the European Union. As we are informed, this investigation revealed that despite the fact that the current legislation is harmonising and comes from the EU, each Member State follows its own practice, while it seems that no state takes into account who issues the invoices for the export of medicines, since this creates problems in the supply chain. Cooperation between manufacturing companies and independent drugstores is very common practice across Europe. The heterogeneity that prevails in the EU, as the stakeholders believe, will also significantly help in solving the problem that has currently arisen in Cyprus.
