Pharmaceuticals Policy and Law - Volume 18, issue 1-4

Authors: Caturla Goñi, Mercè

Article Type: Research Article

Abstract: Towards African Regulatory harmonization processes - Accelerating patient access to medicines. The role played by properly functioning regulatory systems towards enhancing access to essential medicines for patients is crucial. This is especially the case in Africa which has seen progressive growth in the regulatory environment. At the center of this growth has been the African Medicines Regulatory Harmonization (AMRH) initiative. This initiative seeks to strengthen regulatory capacity and encourage harmonization of regulatory requirements - with the ultimate aim of expanding access to quality, safe, and effective medicines for patients in need in Africa. A lot of progress has …been made during the last years, with initial focus on the East African Community, where harmonization related regulations have already been implemented. The same is now being rolled out in other regions such as West Africa and the Southern African Development Community. Removing bottlenecks and reducing redundancies in regulatory processes that slow access to medicines for patients in need today is critical. In this sense, collaboration between the World Health Organization and relevant stakeholders, including the research-based pharmaceutical industry, on collaborative registration procedures that support fast and efficient review and approval of essential medicines in Africa is essential. African regulatory harmonization offers many benefits to regulatory authorities, patients in Africa and industry alike - and most critically for the protection of public health. Show more

Keywords: Accelerated registration, collaborative registration procedure, joint reviews/assessments, Africa Medicines Regulatory Harmonization (AMRH)

DOI: 10.3233/PPL-160437

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 109-120, 2016

Authors: Grampp, Gustavo | Kozak, Robert W. | Schreitmueller, Thomas

Article Type: Research Article

Abstract: Biotherapeutic products (BTPs), also known as biotherapeutic medicines, contain structurally complex active substances produced by living organisms. Due to their complexity and method of manufacture BTPs require distinct regulatory approval standards relative to chemically-synthesized small molecule medicines. This is also relevant for licensing copied versions of a BTP, or similar biotherapeutic products (SBPs) made by a different manufacturer where regulatory concepts developed for generics should not have been applied. In all these licensing scenarios regulators need to evaluate the results of comparability exercises, including sensitive head-to-head analytical, pre-clinical and clinical comparisons with the original product as a basis for approval. …SBPs do not contain chemically identical active substances, and may have slightly different benefit-risk profiles, therefore it is necessary to monitor post-approval safety on a product-specific basis. Policymakers may therefore emphasize the need for product-specific identification in patient records and safety reports using either a unique trade name or a distinguishable non-proprietary naming system. The unique nature of BTPs also informs the nature and degree of interchangeability between the originator and SBPs versions. Many policymakers also emphasize that switching between SBPs should only occur with the involvement of the prescriber. It is recommended that pharmacy substitution would only be appropriate when there is a robust framework for a competent authority to assess product-specific evidence of interchangeability. Another challenge is posed by the historical existence in some jurisdictions of copy BTPs that were not assessed according to current regulatory standards. To address this situation the World Health Organization has proposed a regulatory assessment framework wherein the status of such products can be normalized via the orderly submission and review of supplementary data. Show more

Keywords: Biosimilar, biologic, comparability, similarity, manufacturing, non-proprietary names, interchangeability, substitution, pharmacovigilance

DOI: 10.3233/PPL-160438

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 121-139, 2016

Authors: Rönninger, Stephan K. | Garbe, Joerg H.O.

Article Type: Research Article

Abstract: The presented facts suggest that import testing does not protect patients. On the contrary, it introduces potential risks to access of medicines and reduces the remaining shelf life time of medicines driving possible drug shortage. In the absence of data proving the evidence that import testing is decreasing risk to patients, if manufacturers comply with the evolving Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) regulations, including secure supply chains with documented controls, import testing should be waived. In these cases, importing country's Health Authorities should be confident the product is safe, of high quality, and in compliance with …registered specifications. This article presents risk assessments demonstrating that product quality is continuously controlled. Moreover, import testing does not detect counterfeit or substandard products nor reduces the additional risks related to local distribution channels, as testing occurs at the point of entry into a country. Show more

Keywords: Import testing, importation, testing, Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), risk assessment

DOI: 10.3233/PPL-160439

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 141-156, 2016

Authors: Trujillo, Juan Carlos | De Guzman, Ma. Alejandra

Article Type: Research Article

Abstract: Every day Pharmacovigilance becomes increasingly important to patient health. There are some gaps and limitations in the current Latin American Pharmacovigilance framework which could be addressed to have a better system to correctly and promptly identify suspected adverse drug reactions (ADR). Considering this context, Vigilantia was born as an initiative to foster Pharmacovigilance both scientifically and educationally, and enhance all aspects of the safe and proper use of medicines, across all Latin America.

Keywords: Pharmacovigilance, patient safety, Vigilantia, adverse drug reaction (ADR)

DOI: 10.3233/PPL-160440

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 157-162, 2016

Authors: Mages, Rubie | Kubic, Thomas T.

Article Type: Research Article

Abstract: Counterfeit medicines are, first and foremost, a matter of patient health and safety. Counterfeit medicines pose a threat to patients because of the conditions under which they are manufactured, in unlicensed, unregulated, uninspected and often unsanitary sites. The ``medicines'' themselves pose a threat to patient health and safety because their contents are not regulated and they may not contain the correct active pharmaceutical ingredient (API) to deliver the therapeutic benefit for which they were prescribed, or even ingredients that are themselves harmful such as heavy metals or pesticides. To mitigate that threat, and ensure that their patients receive …safe and effective medicines, pharmaceutical companies have incorporated anti-counterfeiting technologies into their packaging and implemented campaigns to detect and disrupt those counterfeiters who place greed above patient safety. Although counterfeiting presents a global threat from which no company, therapeutic area, region or country is immune; gauging the true scope of the problem has remained a challenge. There are hopeful signs, however, as we have seen improved reporting and greater transparency by enforcement and regulatory agencies. Show more

Keywords: Counterfeit, spurious, falsified, fake medicines, pharmaceutical crime, legitimate supply chain, patient health

DOI: 10.3233/PPL-160441

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 163-177, 2016

Authors: Utt, Eric | Wells, Charles

Article Type: Research Article

Abstract: Antimicrobial resistance (AMR) has emerged as a significant threat to global health security and threatens the achievements of modern medicine. Research and successful development of new antibiotics, especially those with novel mechanisms of action vital to combat resistance, has slowed dramatically since the 1980s. Surveillance for AMR is highly variable globally with significant limitations in many countries impeding the ability to fully characterize the problem. Global efforts to control tuberculosis, malaria and HIV are facing increasing difficulties from the emergence of resistance. Similarly, bacteria causing some of the most common infections in communities or in hospitals such as Escherichia coli …and Klebsiella pneumoniae have shown high levels of resistance to third generation cephalosporins requiring treatment with expensive carbapenems as last-resort. Additionally, Streptococcus pneumoniae has shown reduced susceptibility to penicillin in many regions, exceeding 50% in some settings. The cost in lives from AMR over the next 40 years could go as high as 10 million per year with the cost to economic development as high as $3 trillion per year if current trends continue. In addition to ensuring appropriate use of antibiotics and development of novel classes with new or enhanced mechanisms of action, many plans for the global response call for new vaccines as integral to the fight against AMR. Vaccines and antibiotics should be used together to produce synergistic gains in public health, and ultimately, vaccines will extend the clinical utility of antibiotics. The decrease in cases of invasive pneumococcal disease and decrease in prescriptions for antibiotics in some settings resulting from the introduction of broad access to, and utilization of conjugate vaccines for Streptococcus pneumoniae exemplifies the synergy that can be achieved in the fight against AMR. Show more

Keywords: Antimicrobial resistance (AMR), antibiotics, antibiotic stewardship, antibiotic surveillance, vaccines, pneumococcus, S. pneumoniae, pharmaceutical industry, conjugated vaccines, Haemophilus influenzae

DOI: 10.3233/PPL-160442

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 179-197, 2016

Authors: Shaw, Brendan | Whitney, Paige

Article Type: Research Article

Abstract: Companies in many industries are engaging in a changing business environment where the community is expecting greater transparency and ethical standards than in the past. This has been for a variety of reasons associated with globalization, technological and social changes. The pharmaceutical industry is one industry where such issues are regularly under the spotlight. In this context the IFPMA works with its member companies and national associations to enhance the agenda of self-regulation and ethical behavior. The global IFPMA Code of Practice, and the many national industry association codes that implement it, have evolved over time to help the industry …take the lead in driving greater ethical standards and transparency. This article will review the current international business literature on ethics generally, review the functions and evolution of the IFPMA Code of Practice and examine some of the more recent evidence and analysis of the role of pharmaceutical industry codes, ethics and reputation in the pharmaceutical industry. Show more

Keywords: Ethics, compliance, pharmaceutical, codes, transparency

DOI: 10.3233/PPL-160443

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 199-206, 2016

Article Type: Other

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 207-208, 2016