Pharmaceutical Law Research Articles

Leveraging regulatory pharmacist expertise to develop a framework for drug repurposing in underserved areas of the USA

The United States continues to grapple with healthcare access disparities, particularly in underserved regions. Regulatory pharmacists, with their unique expertise in pharmaceutical laws, drug development, and safety regulations, can play a vital role in drug repurposing efforts. This paper proposes a framework for utilising regulatory pharmacist expertise to develop drug repurposing strategies to meet unmet medical needs in underserved areas. We explore the regulatory hurdles, the necessity for collaborative efforts between healthcare professionals, and the potential for drug repurposing to improve healthcare outcomes in rural and socioeconomically disadvantaged communities.

Roles of Individual Institutions in Achieving Pharmaceutical Sovereignty as Exemplified by the Medical Technology Transfer Centre of the Scientific Centre for Expert Evaluation of Medicinal Products

INTRODUCTION. The strengthening of the health system and the improvement of access to medicines directly depend on the development and marketing authorisation of national innovative medicinal products. Technology transfer is a key tool in bringing medicinal products to market.AIM. This study aimed to evaluate the role of the Medical Technology Transfer Centre of the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) in facilitating the implementation of federal projects in medical science and in achieving of pharmaceutical sovereignty.DISCUSSION. This article is an overview of the main trends in and features of the development of the pharmaceutical industry in the Russian Federation and around the world. The article highlights significant federal decisions made to attain pharmaceutical sovereignty and improve access to medicines for the population. The authors consider documents regulating the work of the Medical Technology Transfer Centre and outline its roles and responsibilities. Additionally, the authors analyse the ability of the Medical Technology Transfer Centre to provide project support throughout the medicinal product development process and to address issues pertaining to efficient pharmaceutical development, patent law, and product commercialisation. The article assesses the role of the Medical Technology Transfer Centre in the development of the pharmaceutical industry in the Russian Federation.CONCLUSIONS. The Medical Technology Transfer Centre supports projects as part of efforts to implement federal projects in human medical science. The Medical Technology Transfer Centre can be considered a driver of effective innovative development in the national pharmaceutical industry.

How many drugs are repositioned each year in Europe?

AbstractFor two decades, commentators have argued for law and policy reform to incentivise organisations to develop new indications for (already) authorised drugs, an area of drug development known as ‘repositioning’. In short, they argue that hurdles in patent and pharmaceutical law hinder repositioning and, therefore, reform is required to increase its use. Yet, these arguments are made primarily on anecdotes; the empirical evidence is scant. One foundational question is how many drugs are repositioned each year in Europe. This study develops a method to examine the number authorised each year. The results show a marked increase in repositioning over the last 3 years, and that the number per year is comparable, though slightly fewer than, the number of new compounds, indicating modest to higher‐than‐expected activity. This study considers what the results mean for four suggested reform options, including the EU Commission's recent proposal. We conclude that the reforms may not achieve their goals or that further evidence is required before we can know whether they will be effective. Lastly, this paper explains how the method and data in this study could serve as a benchmark for evaluating the success of future reforms.

The 13 July 2023 Amendment to the Pharmaceutical Law Act

The 13 July 2023 Amendment to the Pharmaceutical Law Act

SPC squatting

Abstract Supplementary protection certificates (SPCs) for pharmaceutical products are an important complement to patent protection which is often inadequate in commercial terms. SPCs are designed to ensure that originators can amortize their high investments in research and clinical trials. But unlike in the USA, for example, the European SPC is not simply a patent term extension. Rather, it is a unique form of intellectual property right whose subject matter is not the overall patented invention, but the active ingredient or combination of active ingredients of a patented and authorized pharmaceutical product. This link between the basic patent and market authorization has led to many questions of interpretation and Court of Justice of the European Union (CJEU) rulings since the SPC Regulation was adopted. An issue that has not yet been decided by the CJEU concerns the discrepancy between the ownership of the patent and the marketing authorisation under pharmaceutical law. This scenario, in which a patent proprietor relies on the marketing authorisation of a third party (possibly even a competitor) in said patent proprietor’s application for an SPC, is also referred to as “SPC squatting”. The following article discusses the admissibility of such a practice de lege lata, which also becomes relevant in light of current reform efforts by the legislator.

Między opieką a usługą - program pilotażowy w zakresie zdrowia reprodukcyjnego w kontekście dostępu osób małoletnich do antykoncepcji awaryjnej

The pilot program in the field of pharmacist services regarding reproductive health is the Ministry of Health's response to President Andrzej Duda's veto of the amendment to the pharmaceutical law, which was to facilitate access to the so-called emergency contraception. This article is an attempt to evaluate the new regulations and discusses interpretation difficulties arising during the work on the new regulations. The study aims to resolve the legal nature of the procedures described in the regulation.

Rapid Separation and Detection of Drugs in Complex Biological Matrix Using TD-CDI Mass Spectrometer.

The drug detection technology plays a pivotal role in the domains of pharmaceutical regulation and law enforcement. In this study, we introduce a method that combines thermal desorption corona discharge ionization (TD-CDI) with mass spectrometry for efficient drug detection. The TD-CDI module, characterized by its compact and simple design, enables the separation of analytes within seconds and real-time presentation of one or two analyte peaks on the mass spectrum most of the time, which reduces matrix interference and improves detection performance. Through experimental investigation, we studied the characteristics of TD-CDI for analyte separation and detection, even with the same mass number, and optimized the TD-CDI approach. TD-CDI-MS was employed for the rapid detection of drugs in various traditional medicine, food products, and human samples. Additionally, by utilizing TD-CDI for segmented hair direct analysis, it becomes possible to trace the drug usage cycle of individuals. This underscores the feasibility of the proposed analytical method within the realm of drug detection.

Dopuszczenie na rynek produktów leczniczych w wyroku Trybunału EFTA w sprawie E-16/14 Pharmaq AS przeciwko Intervet International BV

The publication is a commentary on an important judgment of the EFTA Court of April 9, 2015 regarding the scope of marketing authorization for vaccines or medicinal products. The first part presents the most important information and circumstances regarding the case. Later, you can find the questions that the Oslo District Court referred to the EFTA Court in Luxembourg. The following parts contain a detailed analysis of the EFTA Court's judgment and the author's commentary. I am convinced that by reading this article, every person interested in pharmaceutical law or veterinary law will be able to expand their knowledge. The publication may also prompt reflection on what beneficial solutions Polish law could derive from Scandinavian law.

J-TEC's efforts to industrialize regenerative medicine in Japan

Japan Tissue Engineering Co., Ltd., J-TEC, was launched in 1999 to industrialize regenerative medicine in Japan. We developed the first regenerative medicine product, JACE (autologous cultured epidermis), which received PMDA approval for treating serious burns in 2007. Then, JACC (autologous cultured cartilage), the second product, was approved in 2012 for efficacy on traumatic cartilage defects. In 2014, the Pharmaceutical Affairs Law was revised to the Pharmaceutical and Medical Device Act, and regenerative medicine products, including gene therapies, were newly classified to accelerate productization. Subsequently, Nepic (autologous cultured corneal epithelium) and Ocural (autologous cultured oral mucosal epithelium) for epithelialization of limbal stem cell deficiencies in ophthalmology were approved in 2020 and 2021, respectively. Furthermore, a new product, JACEMIN (autologous cultured epidermis maintaining melanocyte) for vitiligo treatment was approved in 2023. We have developed five products of regenerative medicine that construct human tissues to graft rather than injectable cell suspensions like drugs. To develop regenerative medicine products, it is necessary to ensure the safety of raw materials, standardize the cultivation process, examine cell characteristics on GLP tests, construct transportation methods, build GCTP facilities, and conduct clinical trials on GCP. Re-examinations of JACE for serious burns and JACC for cartilage defects were completed after 7 years of all-case postmarketing surveillance. The commercialization of these products has become a benchmark for domestic regulation and has induced the development of a regenerative medicine industry promoted by Japan.

Medication use review as a service for pharmaceutical care: Conditions for implementation in pharmacy practice


 
 
 Pharmaceutical care is an aggregated pharmaceutical service based on an innovative approach towards the patient’s pharmacotherapy process. It was introduced into the Polish pharmaceutical law system in 2008, but it was not until the end of 2020 that the list of activities included in this innovative health service was clarified. The delayed initiation of pharmaceutical care means that implementation procedures are lacking, making it difficult to fully implement it into pharmacy practice. The initiating service for pharmaceutical care in pharmacy practice is the medication use review (MUR), which, combined with the pharmacotherapy assessment, has the task of detecting and solving patients’ drug-related problems and thus ensuring safety in the pharmacotherapy process. Such important objectives for medication use review face organisational barriers that make its effective implementation difficult and practically impossible, limiting the scope of pharmaceutical care to the consultative aspect in practice. The aim of the article is to present the implementation conditions of medication use reviews in Polish pharmacy practice, which helped to identify the conditions for effective implementation of pharmaceutical care. Achieving the research objectives requires the use of a variety of research methods. To identify the conditions for effective implementation of medication use reviews, the method of analysis of legal acts was used. Apart from that, the analysis of literature and the method of examination of documents were also implemented, which made it possible to determine whether the Polish pharmaceutical law system creates conditions for effective provision of this service in pharmacy practice. The method of observation (the mystery shopper) was also used to indicate the territorial (subjective scope) scope of the provision of medication use review and to identify barriers to their implementation in Polish organisational and legal realities. All the methods applied made it possible to determine to what extent pharmacist shortages in the pharmacy limit the implementation process. The results of the study were subjected to statistical analysis.
 
 

Homemade herbal remedies - tradition with practical relevance

The preparation of homemade herbal remedies has always been practiced by animal keepers and is still employed in farm animals today. In order to document this practice, an ethnoveterinary study was conducted in Bavaria in 2018-2021. The farmers were interviewed on site and the reported recipes were documented in detail and, where possible, also carried out during the interviews. The plant parts used were weighed using a laboratory balance in order to be able to calculate a daily dose per animal or the concentration in the end product for as many of these traditional use reports (UR) as possible. A total of 716 recipes for 884 UR were named in the 77 interviews by the participating farmers. Two thirds (69%) of the formulations mentioned consisted of one or more medicinal plants and 31% dealt with other natural home remedies (honey, vinegar, etc.). Overall, the farmers surveyed preferred the use of single plants in their formulations. Most UR were for cattle (77% of all reports). These traditional remedies are most often used in Bavarian stables for the treatment and prophylaxis of gastrointestinal diseases and metabolic disorders. Furthermore, there was a high correspondence of the medicinal plants used with described UR from two historical reference books. The study participants used their homemade herbal remedies with a high degree of satisfaction and thereby act within the scope of their own responsibility as farmers. This traditional knowledge of herbal preparations containing active ingredients, which has been passed on for generations, may also be a good starting point for a phytotherapeutic supplement in the treatment of farm animals in veterinary practice. Pharmaceutical and feed law framework conditions must be adhered to.

Pharmacy and Dentistry: A Multidisciplinary Study of the Risks of Circulation of Medicinal Products

The relevance of the work is confirmed by the statistics of drug circulation risks and medical errors in dentistry. A multidisciplinary study was conducted through an organizational and economic, forensic and pharmaceutical, criminal and legal, forensic and medical study of the risks of drug circulation and their side effects due to the provision of dental care on the basis of pharmaceutical and medical law. Taking into account the experience of the countries of the world, the risks of circulation of drugs of clinical and pharmacological, classification and legal, nomenclature and legal groups in dentistry have been studied. Medical errors in dental practice with fatal cases are summarized. The consequences of low-quality dental care were given: deterioration of the patient's health; the development of complications (a sharp increase in temperature, worsening of breathing, dizziness, weakness, loss of consciousness, jaw pain, etc.). Cases of urgent invitation of emergency medical aid doctors to transport a patient to the intensive care unit due to medical errors and the use of low-quality drugs were noted. Forensic and pharmaceutical practice in dentistry with violation of criminal proceedings, recovery of material damages for the benefit of patients is described. Peculiarities of dentistry in children are given. Further research is ongoing.

The Medicinal Phage-Regulatory Roadmap for Phage Therapy under EU Pharmaceutical Legislation.

Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, the article shows how the planned legislative revisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 may affect the legal future of phage therapy.

Changes in pharmaceutical prescription authorizations and their impact on the number of prescriptions issued by pharmacists in Poland

Abstract The Pharmaceutical Law Act of September 6, 2001 (PLA) initially granted pharmacists the authority to issue pharmaceutical prescriptions upon its enactment. However, the legislation regulating this matter changed significantly in 2015. Article 96, section 4 of the PLA defined that, in the front of a direct health threat to a patient, a pharmacist could dispense a medication classified under the availability categories Rp or Rpz. In April 2020, the imprecise term “sudden” in relation to health threats was clarified and removed. Concurrently, all active pharmacists were granted the authority to issue prescriptions, commonly known as pro auctore and pro familiae. The aim of the study was to illustrate the influence of legislative processes on the number of prescriptions issued by practicing pharmacists. To conduct the study, we employed a legal and comparative analysis of relevant legal provisions, followed by a statistical analysis of data obtained from the E-Health Center about the number of prescriptions issued. The results indicated that since the extension of pharmacists’ rights (after April 2020), the average number of pharmaceutical prescriptions issued per month was 151,082. Between May 2020, when pharmacists were granted the authority to issue pro auctore and pro familiae prescriptions, and October 2023, 1,460,385 such prescriptions were dispensed. As a result, a significant relationship between the form of the legislative norms empowering pharmacists to independently prescribe Rx status medicines and the effectiveness of these amendments as measured by the number of prescriptions issued was demonstrated.

Materiały do dziejów ustawodawstwa medycznego i aptekarskiego we wczesnonowożytnym Elblągu (cz. 1): siedemnastowieczna Ordinantz, Der Herren Medicorum, Apothecker, Barbierer

Primary Sources to the History of Medical and Pharmaceutical Law in Early Modern Elbing/Elbląg (part I): the 17th century Ordinantz, Der Herren Medicorum, Apothecker, Barbierer Unlike in other large cities of Royal Prussia, i.e., Gdańsk/Danzig and Toruń/Thorn, the intra-city legislation regulating the local market for medical, surgical, apothecary, and midwifery services in Elbląg/Elbing have been largely overlooked by scholars. Additionally, the history of healthcare and pharmacy organization in Elblag remains a little-explored topic in both Polish and foreign historiography. The article aims to analyse the hitherto unknown 17th c. ordinance for physicians, apothecaries, and barbers issued by the Elbląg city council, and provides the trustworthy primary text (scholarly edition) to researchers.

Medical Errors in Health Care Institutions: an Interdisciplinary Study of the Competences of Specialists Based on Medical and Pharmaceutical Law

In global medical practice, physicians have faced criminal charges such as manslaughter, reckless endangerment, or negligent homicide following fatalities of patients. A comprehensive and interdisciplinary study was carried out, involving forensic and pharmaceutical, medical and immunological, as well as criminal and legal expertise. This study focused on the competencies of healthcare facility professionals, guided by medical and pharmaceutical law within the legal framework of interactions between doctors, patients, pharmacists, and lawyers. It specifically addressed medical mistakes made in the field of gynecology. The research encompassed an analysis of how leading countries worldwide handle medical errors. It categorized common medical missteps, including hazardous surgical methods, infections from medical care, diagnostic inaccuracies, and risky blood transfusions. The forensic and pharmaceutical practices related to gynecological medical errors were scrutinized. Furthermore, the study led to the proposition of normative initiatives for amendments and additions to Article 140 of the Criminal Code of Ukraine, aiming to address these issues more effectively.

Taking a Break? The Growing Trend of FY3: Why More Junior Doctors are Taking Time Out after the Foundation Programme and What They Elect to Do?

There is a growing trend of UK doctors taking time out of clinical training following completion of the Foundation Programme. At a time when NHS services are facing unparalleled demand, considering the reasons why early career clinicians are deciding to delay entry into specialist training is paramount. Here, we describe some of the push and pull factors contributing to the “FY3” year phenomenon as well as the avenues doctors explore. Within the NHS, clinical fellowships can offer more flexibility in terms of rota and location compared to specialty training posts whilst also providing clinical experience and the chance to develop highly sought-after skills in teaching, research, and leadership. Similarly, locum rotas can be negotiated and usually offer significantly enhanced pay. Outside of the NHS, healthcare systems in Australia, New Zealand, and Canada actively seek out UK doctors, incentivising them with better work–life balance, increased pay, and improved working conditions, leading many doctors who had intended to return to the NHS to stay abroad. Doctors are also becoming increasingly aware of their transferable skills and the value they can bring to non-clinical roles in the pharmaceutical industry, management consulting, and medical law. Although the FP was originally introduced to address issues surrounding career progression and poor training experiences, current push factors for taking an “FY3” including increasing competition for specialty training posts, an imbalance towards service provision versus training, and high workload suggest systemic issues within the UK health service are undermining this aim and ultimately leading doctors to take time out of training.

MEDICATION ERROR OF EXPIRED DRUGS FOR AMBULATORY PATIENTS

Medication errors are commonly found in patient prescriptions. In Article 12 of the Pharmaceutical Law, these cases are only subject to administrative sanctions. It is also stated in the Minister of Health Regulation No. 72/2016 Articles 3 and 12 that the sanctions imposed are only administrative sanctions in accordance with the provisions of laws and regulations. The regulation is quite unclear, and will be clarified in the discussion of this research to identify laws that provide protection for ambulatory patients. The high problem of medication errors in patients indicates that it is required to take real action to prevent these cases to occur which cause detriment to the patient. Therefore, the objective of this research is to determine the factors that cause medication errors in the prescribing and dispensing phases. The research method used in this research is normative research with prospective data collection techniques which both methods can provide an overview and accuracy of data regarding the problem of medication errors on expired medicines. The results indicated that the factors causing medication errors in the prescribing phase and dispensing phase, such as work distractions such as ringing telephones, workload on health workers who are unable to do each job themselves, miscommunication between doctors and pharmacists about the use of drugs for patients, unsupported conditions while working, and education on writing prescriptions that do not comply with the requirements for completeness of prescriptions; the lack of a drug preparation room; and education regarding drug preparation that is not in accordance with prescription requests.

Czy podawanie leków aptecznych z innych państw Unii Europejskiej stanowi przestępstwo wprowadzania do obrotu produktów leczniczych bez pozwolenia? Rozważania na tle art. 124 Prawa farmaceutycznego

Art. 124 of the Pharmaceutical Law penalizes the act of placing a medicinal product on the market without a marketing authorization. On the basis of this provision, consideration should be given to the worrying practice of instituting criminal proceedings by law enforcement agencies against doctors, who administer to patients, pharmaceutical drugs manufactured in other EU countries, than Poland. The subject of the first part of the article is to answer the question whether the administration of medicinal products to patients, as part of the conducted medical practice, constitutes an act of placing on the market at all. For this purpose, the notion of medical services and treatment in terms of Polish law, doctrine and Community regulations was analyzed. Subsequently, the subject of considerations is the characteristic of "placing on the market" under Art. 124 of the Pharmaceutical Law, not defined in this Act. Against the background of the judicial activity of the Supreme Court and common courts, an clearly view can be formulated, that the perpetrator of the act may only be the person who made the first transaction with a medicinal product, transferring its possession for further circulation by physically handing it over to the recipient. This position is also confirmed by other penal provisions of the Pharmaceutical Law, which use additional features of "use" and "sharing" of a medicinal product. Thus, it should be considered that in Art. 124 of the Pharmaceutical Law, the legislator decided to criminalize only the act of placing medicinal products on the market, without providing for a criminal sanction for their use, delivery or making available.

Japanese Laws and the Current Status of Regenerative Medicine in the Tohoku Region.

The aim of this study was to review Japanese laws regarding regenerative medicine and the current status of clinical application of regenerative medicine, to learn about the advantages and problems, and to thereby serve as a reference for measures necessary for the development of regenerative medicine. Regenerative medicine started in 1957 with the transplantation of hematopoietic stem cells, followed by the establishment of embryonic stem cells in 1981 and induced pluripotent stem cells in 2006, and continues to evolve progressively. At the same time, however, problems have emerged due to lax legal regulations, such as the use of treatments that lack scientific evidence. The Japanese government enacted two laws to regulate regenerative medicine: the Law to Ensure the Safety of Regenerative Medicine and the Amend the Pharmaceutical Affairs Law in 2013. These laws were enacted with the aim of providing safe regenerative medicine promptly and smoothly and developing many regenerative medicine products. In these laws, regenerative medicine is defined as medical treatment that restores lost functions of damaged organs and tissues with the help of cellular and tissue-based products. Nowadays, there are two major methods of regenerative medicine. One representative method involves the transplantation of devices that activates self-regenerative ability by introducing living cells into patients' body. The other method is the activation and differentiation of endogenous stem cells with cell growth and differentiation factors. The current status of regenerative medicine in the Tohoku region after the enactment of these laws is described in detail. This clarified the advantages and disadvantages associated with regenerative medicine as it is currently practiced in Japan. Development of regenerative medicine in dentistry will be advanced by learning about its clinical application in medicine.