From the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit.

The departure of the UK from the European Union (EU) and affiliated European regulatory bodies, including the European Medicines Agency, on Dec 31, 2020, has resulted in the Medicines and Healthcare products Regulatory Agency becoming an independent national regulator. This change has required a fundamental transformation of the UK drug regulatory landscape, creating both opportunities and challenges for future development of oncology drugs. New UK pharmaceutical policies have sought to make the UK an attractive market for drug development and regulatory review, by offering expedited review pathways coupled to strong collaborative relations with other leading international medicines regulators, outside of Europe. Oncology is a key global therapy area for both drug development and regulatory approval, and the UK Government has been keen to show regulatory innovation and international collaboration through approval of new cancer medicines. In this Policy Review, we examine the new UK regulatory frameworks, policies, and global collaborations affecting new oncology drug approvals after departure from the EU. We explore some of the challenges that might lie ahead as the UK creates new and independent regulatory review and approval processes for the next generation of cancer medicines.

The international regime of drug control may violate the human right to life and security.

Critics of the international regime of drug control have often pointed to its criminogenic effects, maintaining that drug criminalization gives rise to a profitable illicit drugs market which in turn sustains organized crime networks. Here I will expand upon this critique to argue that the violent crime resulting from the drug criminalization regime may constitute a violation of the human right to life and security. To support this argument, I will discuss the extent to which policy makers and the citizens who empower them may stand morally responsible for unintended but foreseeable consequences of the policies they implement. I will note that a north-south imbalance is at play: while the Global North has been the driving force behind the criminalization regime, the violent criminality entailed by the regime of drug control has impacted the Global South most strongly.

Comparison of controlled drugs and new psychoactive substances (NPS) regulations in East and Southeast Asia.

New psychoactive substances (NPS) are substances of abuse that easily evade existing controlled drug regulations. This study conducted a systematic review on controlled drug regulations and analyzed the numbers of new psychoactive substances (NPS) reported in six East and Southeast Asian countries in comparison to US and UK from 2009 to 2020. Generally, more NPS were reported in the US (551) and UK (400), compared to Japan (379), China (221), Singapore (142), South Korea (99), Malaysia (41), and Taiwan (35). Legislative mechanisms including the specific listing of individual substances, generic control of a family of substances, analogue control of similar substances, temporary bans of new substances were evaluated. In this review, countries that have adopted a combination of legislative mechanisms were able to identify higher numbers of NPS for regulatory control, such as the US, UK, Japan, Singapore, and South Korea. These findings can provide references to countries like Malaysia and Taiwan, to strengthen NPS-related regulations nationally. Countries in the East and Southeast Asian region should be encouraged to collaborate more closely and to implement additional legislative approaches most relevant to the regional NPS trends to bridge the regulatory gap and to prevent the spread of emerging NPS.

Changes in launch delay and availability of pharmaceuticals in 30 European markets over the past two decades.

BACKGROUND: The timing of the launch of a new drug is an important factor that determines access for patients. We evaluated patient access to pharmaceuticals in 30 European markets over the past two decades. METHODS: Launch dates were extracted from the IQVIA (formerly IMS) database for 30 European countries for all pharmaceuticals launched internationally between 2000 and 2017. We defined launch delay as the difference between the first international launch date and the corresponding national launch date, and calculated these for each country in our sample over time. Additionally, we ranked countries according to their launch delays and looked at changes in the ranking order over time. Lastly, we determined the availability of new pharmaceuticals in each country, calculating this as the percentage of these pharmaceuticals that were available in each country during a pre-specified interval. RESULTS: There was a clear trend towards a decrease in launch delays across all countries from 2000 (37.2 months) to 2017 (11.8 months). Over the entire observation period, the three fastest launching countries were the Netherlands, Sweden, and Germany, whereas the three slowest were Bosnia-Herzegovina, Serbia, and Turkey. Germany had the highest availability of new pharmaceuticals with 85.7%, followed by the United Kingdom (83.1%) and Norway (82.9%). Countries with the lowest availability of pharmaceuticals were Bosnia-Herzegovina, Serbia, and Latvia. Gross domestic product per capita was negatively correlated with launch delay (-0.67, p < 0.000) and positively correlated with the availability of pharmaceuticals (+ 0.19, p < 0.000). CONCLUSION: Launch delay and the availability of pharmaceuticals varied substantially across all 30 European countries. Using countries with above-average availability and below-average launch delays as a benchmark, stakeholders may discuss or modify current pharmaceutical policy, if needed, to improve access to pharmaceutical care.

Building care amid navigating liability risks: The possibility of policy-driven care in China's drug-control arena.

For Chinese policymakers, shouldering responsibility is often associated with high liability risk, thus resulting in low-level care for risky and stigmatized populations such as drug users. Therefore, it is crucial to explore ways to improve care access in such an uneasy policy environment. Based on long-term ethnographic fieldwork conducted in Yunnan province in southwestern China from 2013 to 2021, this paper traces the policy-making process of the Yunnan Province Methadone Oral Solution Take-Home Treatment Work Proposal. All stakeholders involved considered this policy attempt "impossible" at first, as the highly addictive methadone becomes an illegal drug once it is taken outside a clinical setting. By analyzing how a group of local government officials, together with medical practitioners and drug users, strive to legitimize and ultimately implement the policy, I argue that people's concern over liability risks strengthens the boundary between methadone as a "drug" and methadone as a "medicine," between methadone solution drinkers as "drug users" and as "patients," and between "inside the clinic" and "outside the clinic." By utilizing a culturalist approach to explore the possibility of care in such a context, this paper reveals that a "heqing heli hefa worthy-of-being-cared-for" discourse is crucial in that it acts as symbolic capital to dissolve the above boundaries embedded in the dominant political culture. Moreover, it is the key cultural logic of the "building" of care. The findings also illustrate how local policymakers negotiate and balance responsibility and liability to create a potential policy space for enabling care practices. Additionally, this study sheds light on the inclusion of care for the most stigmatized and marginalized populations, and has broad implications for policy-making in other contexts.

How Did Zero-Markup Medicines Policy Change Prescriptions in the Eyes of Patients?-A Retrospective Quasi-Experimental Analysis.

BACKGROUND: China implemented the zero-markup medicines policy to reverse the overuse of medicine in public health institutions, by changing the distorted financing mechanism, which heavily relies on revenue generated from medicines. The zero-markup medicines policy was progressively implemented in city public hospitals from 2015 to 2017. OBJECTIVE: This study is expected to generate convincing evidence with subjective measurements and contribute to a more comprehensive evaluation of the policy from both objective and subjective perspectives. METHODS: This study was based on a large patient-level dataset with a quasi-experimental design. We employed the difference-in-difference (DID) method, combined with propensity score matching methods, to estimate the causal effect of the policy in reducing overprescriptions from the patient perspective. RESULTS: The study estimated a statistically significant increased probability that the responded outpatients denied overprescription in their visiting hospitals. The mean interacted policy effect, in percentage points, of all observations were positive (logit DID model: 0.15, z = 10.27, SE = 0.01; PSM logit DID model: 0.15, z = 10.26, SE = 0.01; PSM logit DID hospital fixed-effect model: 0.12, z = 3.00, SE = 0.04). DISCUSSION: The policy might reduce overprescription in public hospitals from the patient's perspective. The patient's attitude is one aspect of a comprehensive policy evaluation. The final concrete conclusion of the policy evaluation can only be made through a systematic review of the studies with rigorous design and with both objective and subjective measurements.

Analysis of Rational Drug Use Effect under Hospital Drug Control System.

Objective: To describe and assess the hospital drug control system's measures. Methods: From 2017 to 2019, examine the changes in medication percentage, important monitoring drug amount, top 10 medications amount, and usage rate of prophylactic antibiotics for type I incisions. Results: The proportion of pharmaceuticals remains below 30%, the number of significant monitoring drugs has decreased, the top ten drugs have shifted from adjuvant to therapeutic drugs, and the use of prophylactic antibiotics for type I incisions has decreased by 10%. Conclusion: The percentage of medications that met requirements by using the drug control system has steadily decreased, and the number of pharmaceuticals for important monitoring pharmaceuticals has steadily decreased, in accordance with national medical insurance policy, as well as improved rational drug usage.

National medicines policy development, Saudi Arabia.

Medicines are at the core of every health system. The World Health Organization recommends countries develop national medicines policies that guide production, procurement, prescription and provision of medicines so that people can access the medicines they need at prices they can afford, while avoiding irrational use. However, the development of such policies is rarely straightforward. We describe important components of the national medicines policy in Saudi Arabia, which was developed within a broader transformation of the health system and the economy. The new policy formalizes existing best practices, shapes emerging policies and sets a direction for future development in four main areas. First, the policy seeks to consolidate institutional roles to provide greater cohesion; second it aims to reshape procurement and prescribing habits, with a greater focus on cost containment; third, it lays out policies which focus on assuring a secure supply of good-quality medicines, including essential medicines with limited profit potential and new products. Finally, the policy supports the growth of the domestic pharmaceutical industry, including the development of human resources. Many sectors and institutions joined in the development of the medicines policy, which was underpinned by a review of the past and current pharmaceutical context in Saudi Arabia, and good practices globally. The resulting policy was built on evidence and endeavours to give clear direction to the pharmaceutical industry and implementing agencies on rules and requirements, professional norms and institutional roles. At the same time, it maintains flexibility to allow for adaptation in a rapidly evolving institutional landscape.

Les médicaments sont au cœur de tout système de santé. L'Organisation mondiale de la Santé recommande aux pays d'élaborer des politiques pharmaceutiques nationales qui déterminent la production, l'obtention, la prescription et la fourniture de médicaments, afin que la population puisse accéder aux traitements requis à un prix abordable sans toutefois tomber dans un usage irrationnel. Mais cette élaboration est rarement simple. Dans le présent document, nous abordons les principaux aspects de la politique pharmaceutique nationale en Arabie saoudite, développée dans le cadre d'une vaste transformation de l'économie et du système de santé. Cette nouvelle politique officialise les bonnes pratiques existantes, façonne les projets émergents et définit une orientation pour l'évolution future dans quatre domaines clés. Premièrement, elle cherche à renforcer le rôle des institutions pour améliorer la cohésion. Deuxièmement, elle vise à remanier les habitudes d'obtention et de prescription, en se focalisant sur la maîtrise des coûts. Troisièmement, elle établit des mesures destinées à assurer un approvisionnement sûr en médicaments de qualité, y compris en nouveaux produits et médicaments essentiels au potentiel de rentabilité limité. Et quatrièmement, elle soutient la croissance de l'industrie pharmaceutique dans le pays, notamment le développement des ressources humaines. De nombreux secteurs et institutions ont contribué à l'élaboration de cette politique, qui s'appuie sur une analyse du contexte pharmaceutique antérieur et actuel en Arabie saoudite ainsi que sur les bonnes pratiques mondiales. Le résultat repose sur des éléments et efforts tangibles. Il montre clairement à l'industrie pharmaceutique et aux organismes de mise en œuvre la marche à suivre en matière de règles et d'exigences, de normes professionnelles et de rôles institutionnels. Et dans le même temps, il prévoit suffisamment de flexibilité pour s'adapter à un paysage institutionnel en constante mutation.

Los medicamentos son el núcleo de todo el sistema sanitario. La Organización Mundial de la Salud recomienda a los países que desarrollen políticas nacionales de medicamentos que guíen la producción, la adquisición, la prescripción y el suministro de estos, de modo que las personas puedan acceder a los medicamentos que necesitan a precios que puedan pagar, evitando al mismo tiempo un uso irracional. Sin embargo, la elaboración de estas políticas no suele ser sencilla. En este documento se describen componentes importantes de la política nacional de medicamentos en Arabia Saudita, que se desarrolló en el marco de una transformación más amplia del sistema sanitario y la economía. La nueva política formaliza las mejores prácticas existentes, da forma a las políticas emergentes y establece una dirección para el desarrollo futuro en cuatro áreas principales. En primer lugar, la política busca consolidar las funciones institucionales para proporcionar una mayor cohesión; en segundo lugar, pretende remodelar los hábitos de adquisición y prescripción, centrándose más en la contención de los costes; en tercer lugar, establece políticas que se centran en asegurar el suministro de medicamentos de buena calidad, incluidos los productos nuevos y los medicamentos esenciales con un potencial de beneficio limitado. Por último, la política apoya el crecimiento de la industria farmacéutica nacional, incluido el desarrollo de los recursos humanos. Varios sectores e instituciones participaron en la elaboración de la política de medicamentos, que se sustentó en una revisión del contexto farmacéutico pasado y actual en Arabia Saudita, y de las buenas prácticas a nivel mundial. La política resultante se creó a partir de pruebas y se esfuerza por dar una orientación clara a la industria farmacéutica y a los organismos de ejecución sobre las reglas y requisitos, las normas profesionales y las funciones institucionales. Asimismo, mantiene la flexibilidad para permitir la adaptación en un panorama institucional que evoluciona muy rápido.