”What’s up with price controls?” Stakeholders’ views on the regulation of pharmaceutical pricing in Malaysia
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SUBMITTER: Loh Y
PROVIDER: S-EPMC10703332 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:ObjectiveThis article examines the relationship between drug price and drug quality and how it varies across two of the most common regulatory regimes in the pharmaceutical market: minimum efficacy standards (MES) and a mix of MES and price control mechanisms (MES + PC).Data sourcesOur primary data source is the Tufts-New England Medical Center-Cost Effectiveness Analysis Registry which have been merged with price data taken from MEPS (for the United States) and AIFA (for Italy).Study designThrough a simple model of adverse selection we model the interaction between firms, heterogeneous buyers, and the regulator.Principal findingsThe theoretical analysis provides two results. First, an MES regime provides greater incentives to produce high-quality drugs. Second, an MES + PC mix reduces the difference in price between the highest and lowest quality drugs on the market.ConclusionThe empirical analysis based on United States and Italian data corroborates these results.
| S-EPMC3447248 | biostudies-literature
Project description:Pharmaceutical products, apart from being essential for medical treatment, are of high value and heavily regulated to ensure the prices are controlled. This systematic review was conducted to identify pharmaceutical pricing mark-up control measures, specifically in the wholesale and retail sectors. The search method comprised the following databases: PubMed, Science Direct, Springer Link, ProQuest, and EBSCOhost and Google Scholar. The results were filtered systematically from the inception of the aforementioned databases until 23 April 2021. Eligible studies were those focusing on the implementation of pharmaceutical pricing strategies that involve a) mark-ups of medicine, and b) pharmaceutical cost control measures. A total of 13 studies were included in this review: seven covered European countries, four covered Asian countries, one covered the USA and one covered Canada. The main points of discussion in the qualitative synthesis were the implementation of medicine mark-ups, price mark-up regulatory strategies and the outcomes of these regulatory strategies. Our findings suggest that Western countries have a lower mark-up margin, around 4% to 25% of the original purchased price, compared to Asian countries, up to 50%.
| S-EPMC9031039 | biostudies-literature
Project description:BackgroundA trade-off exists between affordability of pharmaceutical products today and incentives for firms to provide new and better drugs in the future; an activity that prior studies suggest correlates with profitability, which in turn depends on price regulation.ObjectiveIn this paper we re-examined the relationship between price regulation and pharmaceutical research and development (R&D) intensity, and explored the role of profitability and cash flow in mediating this relation using the latest available data from 2000 to 2017 for the 10 most innovative pharmaceutical companies.MethodsFollowing a framework similar to a previous study, we exploited stylized facts about sales volumes in Europe and USA, which give rise to variation in exposure to price regulation. Using ordinary least squares fixed effects models, we assess whether price regulation is related to R&D investment through cash flow effects and profitability.ResultsWhile exposure to price regulation (measured by relative market share in EU/USA) is related negatively to R&D intensity, and this result is driven by price regulation being negatively related to cash flow and profitability, the results were not significant when firm fixed effects were added to the regression models. Modeling firm dynamics showed that cash flow and profitability of European- and US-based firms responded differently to exposure to price regulation. Thus, firm specific effects play an important role in explaining the negative relationship between price regulation and R&D intensity. These results were robust to the inclusion of different time-varying firm level variables.ConclusionThe findings suggest that investment decisions of firms are most likely driven by long-run inter-firm differences, and that firm effects strongly determine firm strategies in terms of R&D investment.
| S-EPMC7902591 | biostudies-literature
Project description:IntroductionMedicine price transparency initiatives provide public or government on information about the product's prices and the components that may influence the prices, such as volume and product quality. In Malaysia, medicine price transparency has become part of the government's strategies in ensuring adequate, continuous and equitable access to quality, safe, effective and affordable medicines. Since the effect of medicine price transparency depend critically on how prices are presented, this study aims to evaluate the stakeholders' perspective of medicine price transparency practice in the private healthcare system in Malaysia.MethodsThis study was conducted as face-to-face, semi-structured interview. Respondents from private pharmaceutical industries, community pharmacists, general practitioners, private hospital pharmacists, governments, academicians and senior pharmacist were recruited using purposive sampling. Using phenomenological study approach, interviews were conducted, and audio recorded with their consent. Data were transcribed verbatim and analysed using thematic analysis with Atlas.ti 8 software and categorised as strengths, weaknesses, opportunities and threats (SWOT).ResultsA total of 28 respondents were interviewed. There was a mixed perception regarding the price transparency implementation in Malaysia's private healthcare settings. The potential strengths include it will provide price standardization, reduce price manipulation and competition, hence allowing the industry players to focus more on patient-care services. Moreover, the private stakeholders were concerned that the practice may affect stakeholders' business and marketing strategy, reduce profit margin, increase general practitioner's consultation fees and causing impact on geographical discrepancies. The practice was viewed as an opportunity to disseminate the truth price information to consumer and strengthen collaboration between healthcare industries and Ministry of Health although this may become a threat that affect the business survival.ConclusionPrice transparency initiatives would benefit the pharmaceutical industries, consumer and countries, but it needs to be implemented appropriately to prevent price manipulation, market monopoly, and business closure. Future study may want to evaluate the impact of the initiatives on the business in the industry.
| S-EPMC7335703 | biostudies-literature
Project description:Given that the pharmaceutical market has experienced severe market failures, it is necessary that we regulate pharmaceutical prices for many countries. Toward ensuring that pharmaceutical price regulation is efficient, this study investigated the antecedents that lead to an unreasonable pharmaceutical price. Based on 33 case-study countries, this study utilized QCA to analyze the conditional configuration of unreasonable pharmaceutical prices from the perspective of medical service provision. The results showed that the causes of unreasonable pharmaceutical prices are configured by medical service provision, especially cost compensation systems and payment mechanism. This study's conclusions contribute to the research on pharmaceutical price regulation and the institution of medical service provision.
| S-EPMC10101374 | biostudies-literature
Project description:BackgroundReducing alcohol and tobacco availability is one potential way to reduce harm from these unhealthy commodities. This study explores key stakeholders' views in relation to policy priorities and considerations for both alcohol and tobacco availability.MethodsWe conducted semi-structured interviews with 14 stakeholders from alcohol and/or tobacco third sector organizations, government, public health and licensing in Scotland. Interviews explored their views on alcohol/tobacco availability, including its place in the policy landscape and experiences in gaining support for policies. Data were analyzed using thematic analysis.ResultsStakeholders believed that alcohol and tobacco availability have not received as much policy attention as pricing and marketing. Stakeholders highlighted the importance of public support and having sufficient evidence to inform policy. Key considerations for future policies include: drawing on lessons from tobacco control policies to address alcohol availability, considering different aspects of availability (especially online availability), ensuring policies reflect their local context, considering the impact of policies on children, and managing retailers' involvement in the policy process.ConclusionThis study highlights key considerations for policies to address alcohol and tobacco availability. There is a need for more research to consider retailers' views and provide greater detail on specific policy suggestions.
| S-EPMC11771472 | biostudies-literature
Project description:Higher tobacco taxes reduce tobacco use. On military installations, cigarettes and other tobacco products are sold tax-free, keeping prices artificially low. Pricing regulations in the military specify that tobacco should be within 5% of the local most competitive price, but prices still average almost 13% lower than those at local Walmarts.To gain insight into policy leaders' ideas and positions on military tobacco pricing, we interviewed members of the Department of Defense (DoD) Addictive Substances Misuse Advisory Committee and the Advisory Committee on Tobacco about tobacco pricing policies (n = 12).Participants frequently lacked specific knowledge of details of military pricing policy, and the impact higher prices might have on military tobacco use. Most participants thought tobacco should not be sold at military stores, but many also felt that this policy change was unlikely due to tobacco industry pressure, and DoD reliance on tobacco profits to support Morale, Welfare, and Recreation funds.Achieving a tobacco-free military will require changing pricing policy, but this study suggests that for effective implementation, military leadership must also understand and articulate more clearly the rationale for doing so.Previous work has found that adherence to military tobacco pricing policy is inconsistent at best. This study suggests that lack of knowledge about the policy and conflicting pressures resulting from the funding stream tobacco sales represent extend to high level military policy leaders. Without clearer information and direction, these leaders are unlikely to be able to establish and implement better tobacco pricing policy.
| S-EPMC5016848 | biostudies-literature
Project description:BackgroundWhile China has implemented reimbursement-linked drug price negotiation annually since 2017, emphasizing value-based pricing to achieve a value-based strategic purchase of medical insurance, whether drug prices became better aligned with clinical value after price negotiation has not been sufficiently established. This study aimed to assess the changes in prices and their relationship with the clinical value of anticancer drugs after the implementation of price negotiations in China.Methods and findingsIn this observational study, anticancer drug indications that were negotiated successfully between 2017 and 2022 were identified through National Reimbursement Drug Lists (NRDL) of China. We excluded extensions of indications for drugs already listed in the NRDL, indications for pediatric use, and indications lacking corresponding clinical trials. We identified pivotal clinical trials for included indications by consulting review reports or drug labels issued by the Center for Drug Evaluation, National Medical Products Administration. We calculated treatment costs as outcome measures based on publicly available prices and collected data on clinical value including safety, survival, quality of life, and overall response rate (ORR) from publications of pivotal clinical trials. The associations between drug costs and clinical value, both before and after negotiation, were analyzed using regression analyses. We also examined whether price negotiation has led to a reduction in the variation of treatment costs for a given value. We included 103 anticancer drug indications, primarily for the treatment of blood cancer, lung cancer, and breast cancer, with 76 supported by randomized controlled trials and 27 supported by single-arm clinical trials. The median treatment costs over the entire sample have been reduced from US$34,460.72 (interquartile range (IQR): 19,990.49 to 55,441.66) to US$13,688.79 (IQR: 7,746.97 to 21,750.97) after price negotiation (P < 0.001). Before price negotiation, each additional month of survival gained was associated with an increase in treatment costs of 3.4% (95% confidence interval (CI) [2.1, 4.8], P < 0.001) for indications supported by randomized controlled trials, and a 10% increase in ORR was associated with a 6.0% (95% CI [1.6, 10.3], P = 0.009) increase in treatment costs for indications supported by single-arm clinical trials. After price negotiation, the associations between costs and clinical value may not have changed significantly, but the variation of drug costs for a given value was reduced. Study limitations include the lack of transparency in official data, missing data on clinical value, and a limited sample size.ConclusionsIn this study, we found that the implementation of price negotiation in China has led to drug pricing better aligned with clinical value for anticancer drugs even after substantial price reductions. The achievements made in China could shed light on the price regulation in other countries, particularly those with limited resources and increasing drug expenditures.
| S-EPMC10793910 | biostudies-literature
Project description:AimTo understand stakeholders' views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods.Materials & methodsSemistructured interviews with five US stakeholder groups.ResultsWe completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity.ConclusionStakeholders were open to data sharing in multicenter studies that offer value and minimize security risks.
| S-EPMC6022827 | biostudies-literature
Project description:ObjectiveThe WHO Global School Health Initiative aimed to improve child and community health through health promotion programmes in schools, though most focus on preventing communicable disease. Despite WHO recommendations, no asthma programme is included in the Malaysian national school health service guideline. Therefore, we aimed to explore the views of school staff, healthcare professionals and policy-makers about the challenges of managing asthma in schools and the potential of a school asthma programme for primary school children.DesignA focus group and individual interview qualitative study using purposive sampling of participants to obtain diverse views. Data collection was guided by piloted semistructured topic guides. The focus groups and interviews were audiorecorded, transcribed verbatim and analysed using inductive thematic analysis. We completed data collection once data saturation was reached.SettingStakeholders in education and health sectors in Malaysia.ParticipantsFifty-two participants (40 school staff, 9 healthcare professionals and 3 policy-makers) contributed to nine focus groups and eleven individual interviews.ResultsSchool staff had limited awareness of asthma and what to do in emergencies. There was no guidance on asthma management in government schools, and teachers were unclear about their role in school children's health. These uncertainties led to delays in the treatment of asthma symptoms/attacks, and suggestions that an asthma education programme and a school plan would improve asthma care. Perceived challenges in conducting school health programmes included a busy school schedule and poor parental participation. A tailored asthma programme in partnerships with schools could facilitate the programme's adoption and implementation.ConclusionsIdentifying and addressing issues and challenges specific to the school and wider community could facilitate the delivery of a school asthma programme in line with the WHO School Health Initiative. Clarity over national policy on the roles and responsibilities of school staff could support implementation and guide appropriate and prompt response to asthma emergencies in schools.
| S-EPMC8823135 | biostudies-literature