Parliament's health committee has backed in first reading changes to the law on medicines for human use that aim to end drug shortages. The vote was 13 in favour, none against and no abstentions.
The Health Ministry proposed the bill, and an inter-agency working group drafted it. Health minister Katya Ivkova presented it to MPs. The text covers wholesale and retail trade, parallel imports, the Specialised Electronic System for Tracking and Analysis (SESPA) and penalties.
The biggest change is the threshold for a shortage. At present a drug counts as in short supply when 65% of the needed amount is available. The bill says 100% of the amount needed to meet the population's health needs for one month must be available. The calculation will cover the past 12 months, not 6 as now.
Every day, holders of marketing authorisations or registration certificates, holders of parallel import permits and wholesalers will have to send data to SESPA. The data cover quantities supplied, orders, refusals to deliver, planned deliveries and exports. For each exported pack, they must give the receiving country and the product code.
Pharmacies will be able to see in the system what wholesalers have in stock for prescription-only drugs, and will spot gaps faster.
The grounds for limiting exports are widened. When quantities are shown to be too low, the health minister will be able, as an exception, to ban the export of certain drugs if this is needed to protect public health.
Parallel imports from the EU will also get easier. In a shortage, the Bulgarian Drug Agency will have up to 14 days to issue a permit after receiving the documents, and up to another 14 days to decide on the price. One import permit will cover several member states, and after renewal it will have no end date.
Holders of marketing authorisations will tell the agency when they put drugs on the market, when they are about to stop selling them, and why. The bill also sets rules against handing out prescription-only drugs without a prescription, penalties for failing to enter data in SESPA, and wider penalties for retailers who breach delivery rules.
The National Pharmacy Map will be kept and updated through an electronic system. Doctors and dentists will be able to get permission to store and sell medicines in places with no pharmacy. The procedure for issuing permits becomes simpler, because some of the data will be collected by the authorities themselves.
SESPA will become part of the National Health Information System. The ministry backs a proposal by Informatsionno Obsluzhvane for the system to be linked to those of the National Revenue Agency and the Customs Agency. The aim is to coordinate and control deliveries better and to track drugs along the whole chain. Informatsionno Obsluzhvane supports the bill because, it says, the measures turn SESPA into a real tool for tracing drugs and reacting in time to shortages.
Ivkova said the aim is more secure supply, a quick response to gaps and better protection for patients. The main points are traceability, 100% availability on the market and information on every pack.
Dimitar Marinov, chairman of the Bulgarian Pharmaceutical Union, backs the spirit of the law in principle, above all the chance for pharmacies to see wholesale stocks. He said the Customs Agency should have access to drug verification data, to check whether packs have already been paid for by the health insurance fund.
The bill was not on the committee's original agenda. Katya Paneva of the Democratic Bulgaria group said there are many good proposals but MPs should not rush, and that they had not discussed details of the text. Georgi Iliev of the Progressive Bulgaria group replied that the proposals had long been published on the National Assembly's website. Bozhidar Bozhanov, co-chair of Yes, Bulgaria and an MP in the Democratic Bulgaria group, said the bill has many sound ideas.
Ivkova called on MPs to consider the proposals carefully, because they guarantee patients' access to medicines. She reminded them that reasoned proposals can be submitted between first and second reading.