Parliament's health committee has backed, in a first vote, changes to the law on human medicines that aim to fix drug shortages. The Health Ministry proposed the bill. Under the text, exports will face tighter control, imports will be faster when drugs run short, and stock levels will be more open to view.

In places with no pharmacy, doctors and dentists will be able to get permission to keep and sell medicines.

The way a shortage is defined will also change. The threshold rises from 65% to 100% of the amount needed for one month's use. Use will be counted over the past 12 months instead of six.

Every day, data on deliveries, orders, refused deliveries and exports will go into SESPA, the electronic system that tracks medicines. Pharmacies will then see what wholesalers have in their warehouses and spot shortages sooner. The system will be linked to the National Health Information System, to make data exchange easier and to follow deliveries. Anyone who fails to submit data to SESPA will be fined.

There will be more grounds to limit exports. In exceptional cases, the health minister will be able to ban the export of specific drugs, if it is proven that supplies are short and the ban is needed to protect people's health.

Parallel imports from other EU countries will get easier. When a shortage is established, the Bulgarian Drug Agency (BDA) will issue a permit within 14 days of receiving the documents, and will decide the price within the same time. One permit will be able to cover several member states, and after renewal it will have no end date.

Drug companies will have to tell the BDA when they put a medicine on the market or plan to stop selling it, and give their reasons. The bill also includes steps against the sale, without a prescription, of drugs that require one. Penalties for breaches in deliveries by retailers will cover more cases.

Permit procedures will be simpler, because some of the information will be collected by the authorities themselves. The National Pharmacy Map will be kept in an electronic system.

The ministry says the changes are a step towards safer drug supplies and better protection for patients.

The ministry also backs a proposal by Information Services to link SESPA with the systems of the National Revenue Agency and the Customs Agency, so there is fuller information on how medicines move. The proposal is not in the bill.