Fast import in case of shortage and deregistered drugs is needed
The statement of the parallel distributors was announced in the Healthcare Committee in the Bulgarian Parliament
We bring to your attention the arguments of BAMPTD for changes in the Law on Medicinal Products in Human Medicine.
We propose to regulate additional options for the import of medicines for Bulgarian patients into the already protected European market by the Falsified Medicines Directive.
Together with the Federation of Bulgarian Patients Forum we have created an online platform for missing medicines. Our data on 800 alerts indicate that in 61% of cases the shortage is due to temporary or permanent suspension of imports.
We believe that by adopting our proposals, these cases can be resolved effectively and with complete safety for patients, as well as not requiring Bulgarian citizens to travel to neighboring and faraway countries in order to obtain treatment with deregistered from the country drugs due only to marketing reasons.
I would like to draw your attention to the fact that the current legislation does not solve these problems for patients, despite the experts’ claims that such medicines can be delivered under the Ordinance under Art. 9 of the LMPHM. It is known to all participants in this type of procedure that Ordinance No. 10 of 2011 on the Conditions and Procedures for Treatment of Unauthorized Medicinal Products in the Republic of Bulgaria does not regulate the process by which patients in need of such type of deregistered products are provided. It regulates only the supply of medicines which INN is not presented on the Bulgarian market. What is more – Regulation 10 of 2011 only concerns hospitalized patients, and the mass case of all patients who are not admitted to a hospital remains outside its scope. This severely restricts the ability to import deregistered products.
We also invite you to follow the example of countries such as Belgium, the Netherlands, Greece, Cyprus, etc., which have mechanisms in place for rapid intra-community emergency supply and fast deivery and which prove that the single market can benefit patients and authorities for better better access to medicines, not the erection of barriers to the free movement.
We appeal to adopt the following principles, which have been applied in our opinion with specific texts, which will support the supply of medicine in a small and economically attractive market, such as the Bulgarian one. Namely:
- To regulate the procedure for fast import from the European Union in case of shortage of medicines from all distributors and speed up the administrative procedures. All regulatory agencies in the single market operate with the same quality rules and standards. The Verification System, which prevents the entry of counterfeit products into the legal chain, is already fully operational. This is a guarantee that the products imported under the accelerated procedure from the Member States will be of the same quality and control as those authorized for use in Bulgaria.
- In case of shortage or shortage through SESPA and when specific medicines are included in the export ban list, a procedure for their fast intra-community delivery from the wholesalers, except from the respective Marketing Authorization Holder, shall be initiated automatically. There can be no mechanism to ensure patient therapy through local market restrictions alone. A proactive regulatory approach is needed to encourage the import of medicines once they are below the defined minimum of 65% of the population’s needs.
- To supplement Art. 214 with a text that regulates a procedure whereby an identical or similar medicinal product withdrawn from the BDA registers for reasons other than pharmacovigilance may be imported after a parallel import authorization has been given. This would significantly increase the capacity for action by the competent administrative authorities in the absence of medicines and would allow the rapid delivery of a product available in another Member State.
- It is also necessary to regulate the import of the same active substances in different dosage units and packs from other European markets with different sizes of packaging and packaging.
We believe that by adopting our proposals, the state will be assisted in finding solutions to critical situations with the help of a network of over 100 distributors throughout Europe. They set out the cause of distribution in Bulgaria and the EU to make an even greater contribution to the healthcare system, patients and our entire society.
