In connection with the plans of the Ministry of Health for centralized contracting of medicines for the needs of medical institutions and the announced public procurement for 1 billion 200 million BGN.
The Association of Research Pharmaceutical Manufacturers in Bulgaria – Arpharm, the Bulgarian Association of Pharmaceutical Wholesalers- BAPW, the Bulgarian Generic Pharmaceutical Association – BGPharma and the American Chamber of Commerce in Bulgaria – AmCham) on behalf of their members unite around the need for a serious review of the terms and conditions of the centralized contracting of medicines for the needs of medical institutions announced by the Ministry of Health and the related public procurement for BGN 1 billion 200 million.
First of all, we would like to express our support for all the efforts of the Ministry of Health to improve the efficiency of spending public funds. At the same time, however, we would stand behind those decisions that guarantee free and fair competition on the market and the continued and uninterrupted access of Bulgarian patients to drug therapy. After a detailed acquaintance with the conditions of the public procurement and methodology for conducting electronic tenders for the supply of medicinal products announced by the Ministry of Health, we would like to express our serious concerns that the procedure organised in this way will lead to destabilisation of the sector, and thus to restriction of Bulgarian patients’ access to the therapy they need.
We would like to list those conditions laid down in the public procedure which, in our opinion, will lead to a permanent disruption of the supply of medicines on the hospital market and carry other significant public risks.
1. There is no selection criteria for the medicines included in the public procurement for 2 years ahead. There is selective selection of ATC codes by product within an International Non-Patent Name (INN), limiting the participation of certain manufacturers, importers and/or wholesalers.
2. A serious risk of limiting Bulgarian patients’ access to the drug therapy is the requirement for an extremely and unnecessarily high minimum residual shelf life of products at the date of delivery, including without any consideration of the specific differences in the manufacture of certain groups of medicinal products, for example so-called biosimilars or those with a special market exemption regime.
3. The conditions of the procedure severely restrict competition, not only because of the already mentioned lack of equal rights of participation of all products of the Drug Positive List, but also because of the restriction of the possibility to submit variants of offers within a single nomenclature unit. In other words, there is no option to change the commercial product within the INN when participating in the individual hospital tenders, as well as no indication of the specific commercial product (packaging and dosage form) for which the contract is concluded between the contractor and the hospital.
4. An overburden administrative procedure is introduced for the acceptance and execution of requests, as well as placing numerous requirements on the documentation of payment for the supplies made, which in turn will further increase indebtedness in the sector. The attempt to set centrally maximum quantities for each international non-proprietary name (INN) to be purchased by medical establishments for a period of 2 years is worrying. Such a practice is anti-competitive in nature and was applied before 2011, leading to shortages of certain medicines in medical institutions, which was why it was justifiably discontinued by the MoH. It should be made clear to the public and to the medical establishments that the quantities determined in the procedure are only recommended and hospitals should be guided by the needs of their patients when preparing their individual tenders.
5. In addition, we consider that there are serious deficiencies in the design of the electronic platform itself, in terms of information security guarantees. Given the huge scale of the procurement (£1 billion 440 million including VAT and market allocation for 2 years ahead), we believe that the issue of ensuring transparency and reliance on anti-corruption protection has been completely underestimated in the procurement of the system.
In conclusion, on behalf of the Association of Research Pharmaceutical Manufacturers in Bulgaria – Arpharm, the Bulgarian Association of Pharmaceutical Wholesalers – BAPW, the Bulgarian Generic Pharmaceutical Association – BGPharma and the American Chamber of Commerce in Bulgaria – AmCham, we would like to express our readiness to find a partnership and workable solution for the introduction of centralised medicines contracting, given the obvious public benefits. To this end, we would like to call on the Bulgarian authorities and society to take a proactive stance and build a faster, quality and safe system for supplying hospitals with medicines.