Tuesday, 18 September 2018 | 17:30:40 Nadezhda Nenova
Amendments to the Law on Medicinal Products in Human Medicine and the Ordinance on the Conditions, Rules and Procedure for Regulation and Registration of Prices of Medicinal Products have been requested by the Bulgarian Association for Medicines Parallel Trade Development of (BAMPTD). The requested changes were presented at the Round Table on "Promoting parallel imports", which took place today in the capital city.
"Broadening the access is related to refinement and addition of texts in the national legislation - LMPHM and the Ordinance on prices. An adequate regulatory framework would result in the resolution to a large extent of drug shortages in Bulgaria and the access of patients in Bulgaria to the variety of medicines in all European countries, not just those registered on the local market" said in his presentation the Hristophor Ivanov - chairman of BAMPTD.
According to him, the change in LMPHM should allow a medicinal product authorized for use in another Member State to be imported when it is the same or similar to a medicinal product authorized for use in the Republic of Bulgaria. In addition, in order to detect a shortage through an electronic system, the BDA would allow for rapid intracommunity delivery by wholesalers. "At the moment only the marketing authorization holders can carry out this delivery with the permission of the BDA" Ivanov said.
These changes according to the Association will ensure that the drugs will still be present on the Bulgarian market, there will be responsible for pharmacovigilance and control by the relevant authorities will be imposed, doctors and pharmacists will be able to apply the necessary treatment and patients will find the same medicinal product at the pharmacy or hospital without the need to supply it from other countries.
The changes to the Ordinance on the prices of medicinal products should allow the imported product to "step" on the registration already made by the first importer. "This means that medicinal products from parallel import have to receive the price of the medicinal product already in place. We want to reach the lower price not by regulation but by the market principle" explained Ivanov.
During the round table, the interim results for the first three months of the BAMPTD internet platform were also presented, with signals for missing medicines. "Our first conclusions show that the signals have solutions. 20% of them are available in the country and the patients are informed about the pharmacies from where to get their medicines. More than 60% have been advised to consult with the treating physician to assess whether and how to adapt the therapy. A very large proportion of alerts - about 32%, concern medicines with temporary or permanent discontinued imports or sales on the territory of the country. 53% of the signals could be resolved by imports. 120 are the drugs, which means that there are more than one signal for about 34%, said Boryana Marinkova, Executive Director of the Association.
According to her, the legislative changes will allow Bulgarian patients to have access to medicines that have problematic import into Bulgaria and will not have to travel or resort to unregulated practices exposing patients at risk.