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Objectives: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000–15 and health technology assessment (HTA) role in these processes.Methods: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis.Results: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013–14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses.Conclusions: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

Objectives: The economical crisis and the requirements for structural changes in all aspects of public health brought a new era of reforms in the country as well as the health care system itself. The Pharmaceutical Legislation, both European and national, were implemented to protect public and state interests. Application of new legislation influenced provider of health care services in different areas. Therefore it is important to evaluate the impact and performance on costs and revenues of health care services provider. MethOds: Monitoring, calculation and assessment of costs and revenues with the help of financial analysis indicators for years 2003-2012, using financial statements was conducted, with respect to profitability, debt, liquidity, working capital and efficiency ratios. These ratios constituted significant information of implementing new health care legislation and price policies. Results: In case of profitability, parameter gross profit ranged from x 2003-2011 = 16.1-22.8% (x average = 19.2%, X mean = 19.8%, σ = 2.4), but in 2012 decreased on 14.3%. Net profit ranged x 2003-2011= 12.8-18.3% (x average = 14.6%, X mean = 16.6%, σ = 4.9%), while in 2012 reached only 2.3%. Debt parameters varied from x 2003-2012= 2.33-4.8 (x average = 3.44, X mean = 3.06, σ = 0.82), liquidity parameters current ratio x 2003-2012 = 1.1-1.7 (X average = 1.43, X mean = 1.45, σ = 0.15) and quick ratio x 2003-2012= 0.7-1.3 (x average = 1.16, x mean = 1.09, σ = 0.15), working capital ratio x 2003-2012 = 2,7-12,9, (X average = 9.6, X mean = 10.1, σ = 3.1) and efficiency ratios were measured either. cOnclusiOns: Implementation of new health care legislation and price policy that were intended to apply restrictive measures to increase system efficiency and cost savings had a significant impact on health care services providers by worsening profitability and liquidity parameters as key indicators of provider stability. Despite the improvement in debt ratio, working capital ratio and efficiency ratios, stability may be threatened and may affect the amount of health care services providers. PHP265 THe effecT of DecenTraliseD Public HealTH care Provision on accessibiliTy To MeDicines in bosnia anD HerzegovinaMelck B. , Ando G. , Izmirlieva M. IHS, London, UKObjectives: This study aims to assess the extent of the restriction on access to medicines in Bosnia and Herzegovina in relation to the country's decentralised provision of health care, with three separate state entities and 10 cantons within the federation of Bosnia and Herzegovina all having a role in the provision of public health care. MethOds: A comparison was made between the contents of the federal essential drug list and the drug lists of the various entities and cantons, in order to ascertain which medicines were available, at what price, and with what level of reimbursement. Results: The federal essential list contains the basic INNs which must be provided by each canton, but there were some important differences between the lists of the various entities and cantons. F...

Aim/objective: Since 2007, companies in the EU must submit paediatric investigation plans (PIPs) for new drugs, unless the PIP is waived and the review article investigated if that improve the child healthcare. Methods: We analysed the EU Paediatric Regulation (EUPR), PIP decisions, PIP decision patterns, EU key documents on "better medicines for children" and examined PIP studies versus the epidemiology described in the reference literature. We examined how PIPs translate into studies by checking www. clinicaltrials.gov and www.clinicaltrialsregister.org. We also investigated the medical sense of PIP-demanded clinical studies in adolescents. Results: The EUPR in Art. 2 (1) defines “paediatric population” as those between birth and 18 years. It lists challenges in dosing and safety of drugs in neonates and infants as if these challenges apply to anybody < 18 years. PIPs demand studies in adolescents although this group needs separate dose finding and efficacy studies only in exceptional cases, if at all. Most PIP studies in rare diseases are unfeasible: too many studies for too few patients in general. Two questionable PIP studies were discontinued in 2016, in one of them several patients died. Conclusions: Neonates and infants have immature organs, with resulting potential for drug over/underdosing. PIPs equalize the legal definition of childhood with a biological limit. The resulting automatism leads to a worldwide threat to children. Most PIP-demanded studies are medically senseless, some even worse. Ethics committees should reject questionable PIP studies and suspend such ongoing studies immediately.