Hand Sanitizer: Regulatory Perspective in Different Countries

Considering the new Coronavirus pandemic, the interest for antimicrobial products, for example, sanitizers and hand sanitizers are soaring. Regulatory authorities are performing their function by giving approvals to hand sanitizers in various countries through various regulations and marketing authorization procedures. The point of this article is to help in understanding the administrative prerequisites expected to bring the hand sanitizers or sanitizer items into various business sectors, just as the current administrative exceptions and interval gauges set up to help react to COVID-19.

The European framework for intellectual property rights for biological medicines

Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and its impact on accessibility of biological medicines and makes some recommendations. Methods: A non-systematic literature review on IP for biological medicines was conducted. Data on authorizations and patent and exclusivity expiry dates of biological medicines obtained from the European Medicines Agency’s (EMA) website and literature was analysed quantitatively and qualitatively. Results: The analysis showed that as at end July 2021, 1,238 medicines were authorized in Europe, of which 332 (26.8%) were biological medicines. There were only 55 biosimilars for 17 unique biologicals. There is an increasing trend in biological authorizations but signifi cant delays in submission of applications for marketing authorization of biosimilars, with no signifi cant diff erences in the time for assessment for marketing authorization between originator biologicals and biosimilars. For some of the more recent biosimilars, applications for authorization were submitted prior to patent and exclusivity expiry. COVID vaccines confi rmed the impact of knowledge transfer on accessibility, especially when linked to joint procurement. Discussion: IP protects originator products and impacts the development of biosimilars. Strategies to improve competition in the EU biological market are discussed. Pricing policies alone do not increase biosimilar uptake since patients are switched to second generation products. Evergreening strategies might be abusing the IP framework, and together with trade secrets and disproportionate prices compared to R & D and manufacturing costs lead to an imbalance between market access and innovation. Conclusion: The European Pharmaceutical Strategy should focus on IP initiatives that support earlier authorization of biosimilars of new biologicals. Recommendations include knowledge sharing, simplifi cation of the regulatory framework and transparency of prices and R & D costs.

PP106 Twenty Years Of Orphan Medicines Regulation: Have Treatments Reached Patients In Need Across Europe And Canada?

IntroductionThe European Union regulation for orphan medicinal products (OMPs) was introduced to improve the quality of treatments for patients with rare conditions. To mark 20 years of European Union OMP regulation, this study compared access to OMPs and the length of their reimbursement process in a set of European countries and Canadian provinces. Access refers to their full or partial reimbursement by the public health service.MethodsData were collated on European Medicines Agency orphan designation and marketing authorizations, health technology assessment (HTA) decisions and reimbursement decisions, and the respective dates of these events for all the OMPs centrally authorized in 14 European countries (Belgium, England, France, Germany, Hungary, Italy, the Netherlands, Norway, Poland, Scotland, Slovakia, Spain, Sweden, and Switzerland) and four Canadian provinces (Alberta, British Columbia, Ontario, and Quebec).ResultsSince the implementation of the OMPs Regulation in 2000, 215 OMPs obtained marketing authorization. We found that Germany had the highest level of coverage, with 91 percent of OMPs being reimbursed. The three countries with the lowest reimbursement rates were Poland, Hungary, and Norway (below 30%). We observed that Germany had the quickest time to reimbursement following marketing authorization, followed by Switzerland and Scotland. We observed that Poland, Hungary, and Slovakia consistently had the longest time to reimbursement.ConclusionsWe observed substantial variation in the levels and speed of national reimbursement of OMPs, particularly when comparing countries in Eastern and Western Europe, which suggests that an equity gap between the regions may be present. The data also indicated a trend toward faster times to reimbursement over the past 10 years.

Regulatory Exclusivity Rights and Medicines

This chapter provides a detailed analysis of the rules that govern the award of regulatory exclusivity rights, which focuses on the EU law. It talks about the arrangements around Northern Ireland that will incentivize the UK and EU to stay in close alignment in heavily regulated product markets, such as pharmaceuticals. It also sets out an overview of the law surrounding the full and abridged generic marketing authorization applications from an exclusivity perspective. The chapter covers some of the seminal judicial decisions, which demonstrate the legal challenges and decisions that have shaped the current position. It provides a summary of the basics of data and market exclusivity in the EU.

Potential negative impact of reputed regulators’ decisions on the approval status of new cancer drugs in Latin American countries: A descriptive analysis

Background Many new cancer drugs are being approved by reputed regulatory authorities without evidence of overall survival benefit, quality of life improvement, and often based on clinical trials at high risk of bias. In recent years, most Latin American (LA) countries have reformed their marketing authorization (MA) rules to directly accept or abbreviate the approval process in case of earlier authorization by the European Medicines Agency (EMA) and the US Food and Drug Administration, mainly. This study assessed the potential impact of decisions taken by EMA regarding the approval of new cancer drugs based on no evidence of overall survival or in potentially biased clinical trials in LA countries. Design Descriptive analysis. Setting Publicly accessible marketing authorization databases from LA regulators, European Public Assessment Report by EMA, and previous studies accessing EMA approvals of new cancer drugs 2009–2016. Main outcome and measures Number of new cancer drugs approved by LA countries without evidence of overall survival (2009–2013), and without at least one clinical trial scored at low risk of bias, or with no trial supporting the marketing authorization at all (2014–2016). Results Argentina, Brazil, Chile, Colombia, Ecuador, Panama and Peru have publicly accessible and trustful MA databases and were included. Of the 17 cancer drugs approved by EMA (2009–2013) without evidence of OS benefit after a postmarketing median time of 5.4 years, 6 LA regulators approved more than 70% of them. Of the 13 drugs approved by EMA (2014–2016), either without supporting trial or with no trial at low risk of bias, Brazil approved 11, Chile 10, Peru 10, Argentina 10, Colombia 9, Ecuador 9, and Panama 8. Conclusions LA countries keep approving new cancer drugs often based on poorly performed clinical trials measuring surrogate endpoints. EMA and other reputed regulators must be aware that their regulatory decisions might directly influence decisions regarding MA, health budgets and patient’s care elsewhere.

Authorization of Vaccines in the European Union

The current COVID-19 pandemic has had a vertiginous accelerating effect on the time from identification of a new virus to a vaccine being deployed. A key step in this journey, the marketing authorization process, is under intense scrutiny and time pressure. The marketing authorization is a necessary gateway that protects public health and provides healthcare professionals and the general public with reliable and relevant evidence reflected in the product information to allow the safe and effective use of these vaccines. Regulators have the expertise and the duty to evaluate vaccines’ benefits and risks and, importantly, monitor safety during clinical use. This evaluation is more important than ever during a pandemic—and must be allowed to be as thorough as ever.

French recommendations for the management of Takayasu’s arteritis

The aim of this National Diagnostic and Care Protocol (PNDS) is to explain to the professionals involved the current optimal diagnosis and therapeutic management and care approach for a patient with Takayasu’s arteritis. Its purpose is to optimize and harmonize the management and follow-up of this rare disease throughout the country. It also identifies pharmaceutical specialties used in an indication not provided for in the Marketing Authorization, as well as the specialties, products or services necessary for the care of patients but not usually paid for or reimbursed.