Pharmaceuticals, policy and law最新文献

{"title":"Ethics and compliance in global pharmaceutical industry marketing and promotion: The role of the IFPMA and self-regulation","authors":"B. Shaw, Paige Whitney","doi":"10.3233/PPL-160443","DOIUrl":"https://doi.org/10.3233/PPL-160443","url":null,"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.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"89 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132299187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Critical points and perspectives on Paediatric Investigation Plans (PIPs) for developing innovative medicines","authors":"D. Brasseur","doi":"10.3233/PPL-2010-0273","DOIUrl":"https://doi.org/10.3233/PPL-2010-0273","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"12 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130124411","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The rare diseases agenda of the European Parliament","authors":"Jorgo Chatzimarkakis","doi":"10.3233/PPL-2009-0247","DOIUrl":"https://doi.org/10.3233/PPL-2009-0247","url":null,"abstract":"During the past years, rare diseases have been one of the main themes on the European Union’s agenda. The reason for this theme being highlighted is the excellent exchange of knowledge between EU policy makers and the relevant patient communities. The former negligence has been caused by the apparent low patient numbers. The definition of a rare disease in Europe contains, that there are less than five patients out of a total population of 10000 persons suffering from this disease. Taking the total of all patients, suffering from rare diseases, it becomes a different number. An estimated 30 million EU citizens are suffering from a rare disease. This tells us that rare diseases are actually not exactly rare. Due to the great part of the population,which is affected, we have a social obligation to prioritise on this matter. Furthermore, the type of health conditions deserves a strong focus. The European Union, and notably the European Parliament, has made significant progress towards the provision of a political framework, which would define rare diseases and provide incentives for the research and development of medicines. The EU Orphan Medicines Regulation, adopted in 1999, was a political milestone in the prioritisation of rare diseases. It has provided the European Union with a clear competence in refining this topic. It was this legislation, which created incentives for medical manufacturers to develop products, furthermore, they generated a market exclusivity going beyond patent protection and a fee waiver for the evaluation and registration process of specialized products. The establishment of the European Medicines Evaluation Agency (EMEA) in 1995, meant the foundation of a centralised body, which can appropriately deal with the necessary central registration of available and registered medicines. This has been a great success story. Since then, 639 products have been registered with the European Medicines Agency. More importantly, the Agency transformed Europe to a leading region for research and development in this field.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"359 ","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"113993904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EU regulatory perspective on rare diseases: Focus on plasma protein related disorders","authors":"J. Kerr","doi":"10.3233/PPL-2009-0239","DOIUrl":"https://doi.org/10.3233/PPL-2009-0239","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"129 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114513923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Needs and PIPs by therapeutic classes: Oncology","authors":"P. Paolucci, V. Cioni, Elisa Caramaschi, C. Cano","doi":"10.3233/PPL-2010-0280","DOIUrl":"https://doi.org/10.3233/PPL-2010-0280","url":null,"abstract":"Childhood cancer affects 12,000 new patients/year in Europe with more than 60 different malignancies. To date, the overall cure rate at 5 years is around 80% in Europe [1] and U.S. [2], with a powerful increase as compared to the cure rates accessible 15 years ago. Although cancer in children is a rare condition, being only 1% of all cancers, it remains the first cause of death in children older than 1 year; still, 3,000 deaths are reported every year. Accordingly, paediatric cancer still represents a therapeutic need and new efficient treatments must be developed, regardless the present cure rates allow to figure out that one adult aged from 16 to 45 years out of 900 individuals has been cured by cancer during childhood [3].","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114899988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Disagreements in the transposition of European rules on medicines into Spanish national regulations","authors":"J. Mallol","doi":"10.3233/PPL-2011-0311","DOIUrl":"https://doi.org/10.3233/PPL-2011-0311","url":null,"abstract":"The European Community is not a Federal organization, like United States for example, but a close community of independent Member States and this presents a problem in the application of any common law from the European Union (EU) over the Member States (MS) because there are not European Federal Laws. To solve this problem in order to have harmonized regulations in all countries, the EU regulatory bodies have developed some legal instruments to be applied by the MS. These main instruments are European Directives, and Guidelines. The European Directives are rules issued by the European Commission, the European Council or the European Parliament with supranational scope. These Directives are not addressed to the citizens but to the MS which are obliged to incorporate in their respective national regulations those aspects as stated in the Directives coming into force before the deadline. Therefore the European Directives have supranational force. The second legal instrument, the Guidelines, are recommendations related to any Directive but without a strict mandatory character. Guidelines are issued help to the MS to transpose and apply the European Directives in all countries in the same way. Therefore, applying both instruments Directives and Guidelines to the transposition of these EU rules into the national system of every MS, the aspects regulated by the European Community are regulated in the same way in all countries. As it is well known, medicinal products are widely regulated within the European Union because of their interest and significance from an economical, scientific and sanitary point of view. These detailed rules are developed by the different legal instruments foreseen in the EU, mainly by Directives, as commented above, to be incorporated into the National regulations of every country in order to be effectively implemented. Of course, this incorporation into regulations at national level has to be performed in the same way in all Member States to state the same prescriptions in all countries. However this correct incorporation into National regulations is not always strictly correct, at least in Spain.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116267450","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advanced therapy medicinal products: Gene therapy","authors":"A. Ayala, Mario F. Muñoz, S. Argüelles, F. Zurita, M. Cano","doi":"10.3233/PPL-140412","DOIUrl":"https://doi.org/10.3233/PPL-140412","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114591382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Import testing turned into an unnecessary limitation of patient access to medicines as risks are managed effectively","authors":"S. Rönninger, Joerg H O Garbe","doi":"10.3233/PPL-160439","DOIUrl":"https://doi.org/10.3233/PPL-160439","url":null,"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.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114793127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of judicialization of health in relation to drugs","authors":"Salamano Mercedes, B. Mariela, G. Elvio","doi":"10.3233/PPL-140389","DOIUrl":"https://doi.org/10.3233/PPL-140389","url":null,"abstract":"","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114805969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulation of nutritional and health claims made on food in the European Union","authors":"J. Valverde","doi":"10.3233/PPL-2009-0224","DOIUrl":"https://doi.org/10.3233/PPL-2009-0224","url":null,"abstract":"The development of foodstuffs and their components that provide a benefit beyond their traditional nutritional value has aroused considerable academic, commercial and legislative interest in recent decades. We are speaking here, among other denominations applied, of functional, fortified and nutraceutical foods. The challenge for society is to ensure that such foods and their components are of good quality, safe and efficacious, and that their marketing does not entail a fraud on consumers’ economic interests. In many cases there are still scientific challenges that have not been satisfactorily resolved, both in the identification of active elements, such as in the mechanisms of absorption, distribution and metabolism in the organism, in addition to uncertainties from the possible interaction of the various additives inter se and their possible physiological potentiations [9]. The situation can fairly be described as a scientific, health, economic and legal challenge.","PeriodicalId":348240,"journal":{"name":"Pharmaceuticals, policy and law","volume":"92 9","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"1900-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132273341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}