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

Authors: Valverde, Jose Luis | Pisani, Eduardo

Article Type: Research Article

DOI: 10.3233/PPL-160427

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

Authors: Wilsdon, Tim | Haderi, Artes | Li, Lilian

Article Type: Research Article

Abstract: A healthy life sciences eco-system^1 is an environment where all stakeholders, patients, researchers, governments, the civil society and manufacturers, work together to support the sustainable development and provision of innovative solutions that address unmet health needs. To build a stronger eco-system, governments could prioritise policy initiatives such as: facilitating the commercialisation of academic research; encouraging clinical research; accelerating the adoption and diffusion of new innovative medicines; and promoting the local market as a place to invest and deliver life sciences innovation [1]. Historically, the development of medicines has been primarily undertaken in, and for the benefit of, high income …countries. Over the last 20 years, this has started to change, partly as a result of the market opportunity increasing in middle-income countries (MICs) and low-income countries (LICs) and partly because governments in these countries have recognised the importance of encouraging innovative industries, resulting in a greater priority given to addressing diseases highly prevalent in MICs and LICs. In this article, we draw on our experience to develop lessons on how to establish a sustainable life sciences eco-system in MICs and LICs. We highlight the importance of different types of government policy (industrial policy, the regulatory framework, intellectual property, and improving access to medicines) and how success requires different stakeholders (public and private, international and national) to work together. Show more

Keywords: Policy, lessons, life science, eco-system, sustain, Africa, China, India, Brazil, pharmaceuticals, medicines, LICs, MICs

DOI: 10.3233/PPL-160428

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 5-17, 2016

Authors: Valverde, Jose Luis

Article Type: Research Article

Abstract: Health is a global concern. The need for a globalized response is evident in the pharmaceutical industry. Although pharmaceutical products are developed and marketed internationally, they are currently regulated only at national level. The pharmaceutical agencies regulate medical products in a globalized environment. However, national regulations can create significant barriers to pharmaceutical availability. We must formulate our laws with a global focus. The globalization of regulation weakens national sovereignty but empowers transnational epistemic networks. For this reasons the pharmaceutical agencies are involved in several bilateral and multilateral cooperation activities with international partners. International cooperation is a key area of work …for the agencies. This process will benefit of advancement in global governance and progress toward supranationalism. The internationalization of the pharmaceutical industry, highly globalized, involves changes in policies, lifestyle and culture, and has altered drug research, production, and regulation. Show more

Keywords: Pharmaceutical industry, globalization, regulations, ICH, governance, governments, pharmaceutical agencies, products liability, pharmaceuticals inspections

DOI: 10.3233/PPL-160429

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 19-29, 2016

Authors: Desai, Manisha A.

Article Type: Research Article

Abstract: Compulsory licenses of patents under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) are often mistakenly viewed as a solution to problems relating to access to medicines in developing countries. Access requires a strong political commitment, a health system that contains multi-disciplined health professionals, and an adequate infrastructure to enable transportation of patients and equipment. The use of compulsory licenses should be a rare event considered only under extremely limited circumstances and not an instrument of industrial policy. If a government decides to issue a compulsory license, there are several technical and procedural requirements that must be …satisfied under TRIPS. This paper explores those requirements and examines instances where courts have issued decisions relating to compulsory license requests or grants. It analyses the key provisions of TRIPS that are relevant to a government grant of a compulsory license without the authorization of the right holder. It also provides examples and analyses of previous grants of compulsory licenses that have been deficient in meeting on more more procedural requirements under TRIPS. Show more

Keywords: Patent law, compulsory license, World Trade Organization (WTO), Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)

DOI: 10.3233/PPL-160430

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 31-44, 2016

Authors: Gawel, Claus Roland

Article Type: Research Article

Abstract: A robust, time-limited system of patent protection is proven to facilitate development of, and access to, innovative pharmaceutical products and processes. In particular, a well-functioning patent protection system is a prerequisite for attracting finance for costly pharmaceutical research, given its high failure rates, by ensuring that successful innovation is rewarded. This article offers a short scientific introduction to current research and development (R{&}D) in the biopharmaceutical industry before going on to consider the economic role of patent protection, in enabling research through access to capital markets and in accelerating access to new, innovative medicines. In this regard, the article discusses …the beneficial economic effects of well-functioning patent systems in regions with restricted access to investors and capital markets. It concludes by underlining the importance of a robust and finely-tuned patent system in contributing to scientific progress and development of new life-saving drugs. Show more

Keywords: Pharmaceutical patients, innovation, research and development

DOI: 10.3233/PPL-160431

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 45-53, 2016

Authors: Aitken, Murray

Article Type: Research Article

Abstract: Understanding the pharmaceutical value chain requires the identification of each component from manufacturer to end consumer of medicines - and to understand their interaction. In most cases, the manufacturer's selling price represents only a fraction of the retail price of a drug. More than half of the end user price results from insurance, freight charges (CIF), import tariffs and charges, importer margin, distributor margin, retailer margin and taxes. The article describes the elements of the medicine value chain, outlines factors and costs that contribute to the difference between the net price a pharmaceutical manufacturer receives for a drug and …the final amount paid for the drug by the end user. It quantifies the price build-up for specific therapy areas and countries and illustrates the diversity of approaches and costs associated with the value chain through case studies. Show more

Keywords: Pharmaceutical value chain, pharmaceutical distribution and retail margins, pharmaceutical cost analysis

DOI: 10.3233/PPL-160432

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 55-66, 2016

Authors: Neufeld, Nora

Article Type: Research Article

Abstract: Recently adopted, the WTO Agreement on Trade Facilitation (TFA) adds fresh momentum to worldwide efforts to speed up the movement, release and clearance of goods across borders. With all required decisions having now been taken in Geneva, preparations are under way to ensure the Agreement's expeditious entry into force. Once in operation, this ground-breaking treaty will significantly accelerate cross-border trade and reduce related costs. This article analyses the TFA from a pharmaceutical angle, highlighting provisions of particular interest to the industry. It will look at how the new Agreement is likely to impact trade in medical goods and where …business stands to benefit. A final segment will review governments' implementation plans and discuss the road ahead. Show more

Keywords: Cutting red tape, expedited clearance, perishable goods, pharma trade, trade facilitation, ratification, WTO Agreement on Trade Facilitation, WTO negotiations on Trade Facilitation

DOI: 10.3233/PPL-160433

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 67-78, 2016

Authors: Lourenco, Celia | Orphanos, Nikolas | Parker, Catherine

Article Type: Research Article

Abstract: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, also known as ``ICH'', is a key international harmonisation initiative founded by the drug regulatory authorities and industry associations from the European Union, Japan and the United States of America. The main objective of ICH is to promote public health globally through the development and implementation of harmonised guidelines and standards. With its recent reform, ICH became an Association under Swiss law, and set the stage to broaden its membership to regulatory authorities and international pharmaceutical industry associations beyond the three founding regions. Building on greater than …25 years of harmonisation work, ICH is now well-positioned to grow into a truly global venue for the development of guidelines and standards to facilitate the registration of human medicines across the world. Show more

Keywords: Pharmaceutical, regulation, harmonisation, guidelines, standards

DOI: 10.3233/PPL-160434

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 79-89, 2016

Authors: Mwangi, John M.

Article Type: Research Article

Abstract: 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

DOI: 10.3233/PPL-160435

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 91-98, 2016

Authors: Lahlou, Oumkaltoum

Article Type: Research Article

Abstract: 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: AMRH strategic plan: Africa Medicines Regulatory HARMONIZATION;, Economic Community of West African States (ECOWAS) and the ECOWAS Regional Pharmaceutical Plan;, Southern African Development Community (SADC);, Organization coordinating endemic diseases in Central Africa (OCEAC);, Regional Economic Communities (REC);, Agreements for Mutual Recognition;, National Medicines of Regulatory Authorities (NMRA);, GMP inspection;, Africa Medicines Agency (AMA);, New Partnership of Africa Development (NEPAD)

DOI: 10.3233/PPL-160436

Citation: Pharmaceuticals Policy and Law, vol. 18, no. 1-4, pp. 99-108, 2016