National medicines policies – a review of the evolution and development processes

OBJECTIVES: Continuous provision of appropriate medicines of assured quality, in adequate quantities, and at reasonable prices is a concern for all national governments. A national medicines policy (NMP) developed in a collaborative fashion identifies strategies needed to meet these objectives and provides a comprehensive framework to develop all components of a national pharmaceutical sector. To meet the health needs of the population, there is a general need for medicine policies based on universal principles, but nevertheless adapted to the national situation. This review aims to provide a quantitative and qualitative (describing the historical development) study of the development process and evolution of NMPs. METHODS: The number of NMPs and their current status has been obtained from the results of the assessment of WHO Level I indicators. The policy formulation process is examined in more detail with case studies from four countries: Sri Lanka, Australia, former Yugoslav Republic of Macedonia and South Africa. RESULTS: The number of NMPs worldwide has increased in the last 25 years with the highest proportional increase in the last 5–10 years in high-income countries. Higher income countries seem to have more NMP implementation plans available and have updated their NMP more recently. The four case studies show that the development of a NMP is a complex process that is country specific. In addition, it demonstrates that an appropriate political window is needed for the policy to be passed (for South Africa and the FYR Macedonia, a major political event acted as a trigger for initiating the policy development). Policy-making does not stop with the official adoption of a policy but should create mechanisms for implementation and monitoring. The NMPs of the FYR Macedonia and Australia provide indicators for monitoring. CONCLUSIONS: To date, not all countries have a NMP since political pressure by national experts or non-governmental organizations is generally needed to establish a NMP. Case studies in four countries showed that the policy process is just as important as the policy document since the process must create a mechanism by which all stakeholders are brought together and a sense of collective ownership of the final policy may be achieved

Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

: In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing the placing on the market of medical devices is decentralized to independent 'conformity assessment' organizations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details-which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE-MD project (Coordinating Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe

Reimbursement Restriction and Moderate Decrease in Benzodiazepine Use in General Practice

PURPOSE: To limit misuse and save costs, on January 1, 2009, benzodiazepines were excluded from the Dutch reimbursement list when used as anxiolytic, hypnotic, or sedative. This study aims to assess the impact of this reimbursement restriction on benzodiazepine use in patients with newly diagnosed anxiety or sleeping disorder in general practice. METHODS: Was conducted a retrospective observational database study deriving data on diagnoses and prescriptions from the electronic health records–based Netherlands Information Network of General Practice (LINH). We looked for patients aged 18 years and older with an incident diagnosis of sleeping disturbance (International Classification of Primary Care code: P06) or anxiety (P74, P01) between January 2008 and December 2009. Incidence of these diagnoses, benzodiazepine use, and initiation of selective serotonin reuptake inhibitor (SSRI) treatment was compared between 2008 and 2009. RESULTS: In total, we identified 13,596 patients with an incident diagnosis of anxiety (3,769 in 2008 and 3,710 in 2009) or sleeping disorder (3,254 in 2008 and 2,863 in 2009). The proportion of patients being prescribed a benzodiazepine after a diagnosis was lower in 2009 than in 2008 for both anxiety (30.1% vs 33.7% P <.05) and sleeping disorder (59.1% vs 67.0%, P <.05), as was the proportion of patients with more than 1 benzodiazepine prescription for both anxiety (36.4% vs 42.6%, P <.05) and sleeping disorder (35.0% vs 42.6%, P <.05). We found no increase in the use of alternative treatment for anxiety with SSRIs. CONCLUSIONS: The reimbursement restriction has led to a moderate decrease in the number of incident diagnoses and initiation of benzodiazepine use in patients with newly diagnosed anxiety or sleeping disorder. This finding indicates that in settings where no such reimbursement opportunities exist, physicians have room to reduce benzodiazepine prescribing. (aut. ref.