Research-based Pharmaceutical Industry Research Articles

Die Rolle des Staates bei der Entwicklung von Arzneimitteln und Impfstoffen

Pharmaceutical research in Germany has, so far, been financed almost exclusively by private companies. Hitherto, the research-based pharmaceutical industry is one of the few sectors that has managed without any noteworthy government research subsidies. Entrepreneurial commitment is still one of the decisive factors for progress in medicine. Direct state subsidies have just played a subordinate role in the past. The fact that the Federal Ministry of Research is supporting the development of vaccines against the SARS-CoV-2-virus with a total of 1.2 billion euros therefore appears even more extraordinary. But besides financial means, the German state is involved in many other ways in the development and approval of medicines and vaccines. The national legal requirements and regulations originate from the pen of the German legislators. At the same time, through various federal institutes and institutions, the German state is involved in the approval procedure, in the release process, in the distribution and in the monitoring of medicines and vaccines. However, the German government is not obliged to participate in the development of new medicines and vaccines in a certain way and to a certain extent. Rather, the type and scope are subject to its wide margin of appreciation which is only limited by the prohibition of insufficient actions. This leeway increasingly gets smaller, the more urgent, threatening and acute a health situation is for life and health of the citizens. In urgent cases as in a pandemic situation, the state’s duty to protect (Art. 2 § 2 Clause 1 of the German Basic Law) can then oblige the state to promote and to push the development of urgently needed medicines and vaccines, although the government remains free to choose the exact way how to fulfil this duty. It remains to be seen if, under the impact of the corona pandemic, the German government will continue to undertake greater (particularly financial) efforts to promote and push the development and the approval of new medicines and vaccines, or if this – what seems more likely – remains an exception for epidemic and pandemic situations.

STUDYING INTERNATIONAL COMPETITIVENESS IN PHARMACEUTICAL SECTOR IN SELECTED DEVELOPED COUNTRIES

Objectives: Competitiveness is the ability of countries in increasing market share, profits, value added, and staying at the scene of fair and international competition for a long period of time. This is realized through market authority and establishing activities based on comparative and competitive advantages. On the other hand, the research-based pharmaceutical industry makes a major contribution to the prosperity of the world economy. It is a robust sector that has been one of the pillars of industrialized economies and is increasingly recognized as an important sector in the developing world as well. Furthermore, global sales of pharmaceutical products represent the international spread of medical technology that comes as the result of highly intensive R and D efforts in the exporting countries (International Federation of Pharmaceutical Manufacturers and Associations, 2012). The present study aimed to analyze and investigate the international competitiveness of pharmaceutical sector in selected developed countries using traditional and new indices of competitiveness.Methods: In this study, revealed comparative advantage index and also static and dynamic intra-industry trade (IIT) indices were used in the period 2000–2012.Results: The results indicated the growing competitiveness in most of the selected countries. Furthermore, the findings suggested that countries with higher levels of international trading of pharmaceutical goods have a higher potential of competitiveness based on IIT and comparative advantage indices.Conclusions: For increase in international competitiveness in pharmaceutical industry, selected developed countries pay attention to both comparative and competitive advantages.

Market Exclusivity Time for Top Selling Originator Drugs in Canada: A Cohort Study.

This study looks at market exclusivity time for the top selling originator drugs in Canada. Total sales for drugs without competition were also calculated. A list of the top selling originator drugs by dollar sales from 2009 to 2015 inclusive, except for 2010, was compiled along with their annual sales. Health Canada databases were used to extract the following information: generic name, date of Notice of Compliance (NOC, date of marketing authorization), whether the product was a small molecule drug or a biologic, and date of NOC for a generic or biosimilar. Market exclusivity time was calculated in days for drugs. A total of 121 drugs were identified. There were 96 small molecule drugs (63 with a generic competitor and 33 with no generic competitor) and 25 biologics (none with a biosimilar competitor). The 63 drugs with a competitor had a mean market exclusivity time of 4478 days (12.3 years) (95% CI 4159-4798). The 58 drugs without competition had total annual sales of Can$8.59 billion and were on the market for a median of 5357 days (14.7 years) (interquartile range 3291-6679) as of January 31, 2017. Top selling originator drugs in Canada have a considerably longer period of market exclusivity than the 8 to 10 years that the research-based pharmaceutical industry claims.

How the Transnational Pharmaceutical Industry Pursues its Interests Through International Trade and Investment Agreements: A Case Study of the Trans Pacific Partnership

This chapter explores the strategies used by transnational pharmaceutical companies and their industry associations to advance their economic interests through international trade and investment agreements. We begin by characterizing the research-based pharmaceutical industry as a transnational industry with a concerted global agenda to expand and extend monopolies over its products, thereby increasing returns for its shareholders. We describe the broad set of strategies employed to meet these objectives. We then give an historical overview of attempts by the industry to use international trade agreements to expand intellectual property rights and constrain the operation of pharmaceutical coverage programs. Focusing specifically on the Trans Pacific Partnership Agreement, we explore the ways in which pharmaceutical industry bodies in the US and other TPP countries have sought to influence the negotiations to further their agenda and protect and promote the industry’s interests.

Valuation of Pharmaceutical Patents: A Comprehensive Analytical Framework Based on Technological, Commercial, and Legal Factors

Patent valuation has for a long time been a matter of serious concern within the research-based pharmaceutical industry. However, although specific drug patents have been evaluated technologically, and economists’ general (non-drug-specific) patent valuation models are well developed, direct application to the pharmaceutical industry of existing approaches to valuation is associated with tremendous challenges. This article proposes a systematic framework for analyzing pharmaceutical patent value, which, unlike previous approaches, will integrate technological, commercial, and legal indicators. This work is of great significance to pharmaceutical researchers, managers, and investors in their decision-making in relation to patents and patent value.

Moral Psychology and the Intuition that Pharmaceutical Companies Have a ‘Special’ Obligation to Society

Many people believe that the research-based pharmaceutical industry has a ‘special’ moral obligation to provide lifesaving medications to the needy, either free-of-charge or at a reduced rate relative to the cost of manufacture. In this essay, I argue that we can explain the ubiquitous notion of a special moral obligation as an expression of emotionally charged intuitions involving sacred or protected values and an aversive response to betrayal in an asymmetric trust relationship. I then review the most common arguments used to justify the claim that the pharmaceutical industry has a special moral obligation and show why these justifications fail. Taken together, these conclusions call into question the conventional ideologies that have traditionally animated the debate on whether the pharmaceutical industry has special duties of beneficence and distributive justice with respect to the impoverished in dire need of their products.

The emergence of the genetically engineered animal models in carcinogenic risk assessment of pharmaceuticals: a case study of process innovation

In this article, we explain the emergence of new short-term tests for carcinogenicity involving genetically engineered animals for the purposes of pharmaceutical regulation. Drawing on some long-standing theories of technological innovation, we argue that the alteration of carcinogenic risk assessment of pharmaceuticals, which occurred from 1998, did not result solely, or perhaps even mainly, from internal logical and technical developments in the experimental sciences of toxicology or genetics. Rather, this process innovation in regulatory science resulted from a complex interaction between scientist activism around molecularization of toxicology in powerful US government institutions, on the one hand, and a powerful research-based trans-national pharmaceutical industry committed to deregulatory mobilization, on the other, seeking to reduce carcinogenicity testing of its products and capable of marshalling significant support from governments and regulators, especially in Europe and Japan, to achieve that goal. The new techno-scientific basis for regulatory decisions about whether pharmaceuticals are carcinogenic risks to the public was, in effect, an accommodation in “bio-political” trading between two power-blocks of expert scientists. Those from industry and their regulatory allies in Europe and Japan, who sought reductions in “the burden” of drug testing, on the one hand, and FDA scientists, who did not accept the simple “reduction” agenda, but were interested in shifting the paradigm of carcinogenicity testing toward geneticization, on the other.

Innovation Market Theory and Practice: An Analysis and Proposal for Reform

Encouraging and/or preserving innovation in mergers and acquisitions have been critical factors in modern antitrust analysis. These aims have been justification for the breakup of proposed research programs targeting diseases as serious as HIV/AIDS and cancer. The rationale given is always to protect competition and enhance the benefits to consumers. Lawyers and economists justify intervention in mergers based on predictions of what will or might happen many years down the road in scientific research programs. They base those predictions on various theories and assumptions of how companies behave. But an examination of the actual drivers in the researchbased pharmaceutical industry, such as the time factor of revenue destruction and the resulting continuing need for new products, along with a review of what happened in key cases after the agencies acted, reveals that those underlying assumptions may well have been unfounded. This factual consideration of how business actually behaves has been missing from the analysis. This article looks at the leading approaches to “innovation markets.” It then reviews the key cases in which the theory has been applied, and looks to see what actually happened after the case files were closed. In other words, did the intervention do any good, and/or did the lack of intervention do any harm?

Providing Access to Medical Products at Prices Patients can Afford is a Priority for the European Parliament

India, popularly described as ‘the pharmacy of the developing world’ both because of it huge market in generic medicines and its developing research-based pharmaceutical industry, has since 2007 been in negotiations to agree on the provisions of a bilateral Free Trade Agreement (FTA) with the European Union (EU). David Martin, with fellow MEPs and a network of public health groups, is calling on the EU Commission to ensure that demands on India to take on higher intellectual property (IP) standards within the terms of the FTA should not undermine the supply of low-cost generic medicines to the poor and suffering of the developing world or set a precedent for the future of IP protection globally.

의약품 거래에 관한 세 가지 규약의 법적 관계 및 쟁점별 비교·고찰*

In 2007 the Korean Research-based Pharmaceutical Industry Association (KRPIA) developed a Fair Competition Code on Pharmaceutical Trade, and in 2010 the Korean Pharmaceutical Manufacturers Association (KPMA) revised its Code of Fair Competition. Prior to 2007, the KRPIA and KPMA made voluntary agreements on pharmaceutical trade. This article examines the three codes in terms of the limits they set on various forms of gift-giving, donations, the funding of academic conferences inside and outside of Korea, the provision of drugs for clinical studies, market surveys, and post-market surveillance studies. The results of this examination show that the KPMA 2010 Code reflects a moral bias against donations to healthcare organizations and grants an exclusive power to the KPMA regarding sponsorships to participate in academic conferences.

Challenges in Pediatric Drug Development

A paradigm change is taking place from protecting children against clinical research to protecting them through research. It is based on a better scientific understanding of the child's physiology, on the increasing potential of biomedical interventions, and on an evolving conviction of children's right to benefit from scientific and pharmaceutical progress. The WHO campaign 'Make medicines child size' is contributing to expand this to a global vision of the health of all children. Research-based pharmaceutical industry develops innovative new medicines for serious and life-threatening diseases. It has built up competency in pediatric drug development and has welcomed US and EU pediatric legislation as well as the WHO campaign. More diseases without effective therapy in the past will become treatable conditions. Eventually these advances will also be reflected in the medical care in developing countries. Research-based pharmaceutical industry can support specific pediatric aspects of drug development in neglected diseases by sharing its learning. The way forward will be a constructive dialog among the key stakeholders to ensure continuing improvement in worldwide child healthcare.

Opening the Black Box of Pharmaceutical Patent Value: An Empirical Analysis

Patents and patent valuation have raised tremendous concerns from the research-based pharmaceutical industry for a long time. Questions about the valuation of drug patent portfolios, the assessment of research and development (R&D) performance or innovation output, and the competitive position of different firms in the industry all tend to revolve around the basic question of phannaceutical patent valuation. This article aims to validate the impact of pharmaceutical technology characteristics on patent value and to optimize classic patent valuation methods in the drug field. We selected 913 patents in the “Orange Book” of the US Food and Drug Administration as the sample, employed established patent value indicators (EPVI) and pharmaceutical technology’ details indicators (PTDI) as key predictors for pharmaceutical patent value (the value of pharmaceutical patents), and further conducted multiple-variable analysis. It was found that PTDI significantly influences pharmaceutical patent value and, more important, enhances the quality of existing valuation methods. Moreover, the marginal effect of individual predictors on patent value is quantitatively measured. For example, new chemical entities and new dosage forms increase the value by 62% and 60%. and orphan drug and pediatric drug classification decrease the value by 7% and 10%, respectively. In addition, the potential commercial applications of this method are briefly explored in view of the eady stage, high-efficiency, and low-cost characteristics of all value predictors in this method.

More Drugs for More Developing World Diseases

The research-based pharmaceutical industry has a key role in improving access to medicines. By continuing to pursue innovative research and development (R&D), it can improve the availability and effectiveness of drugs. By adopting tiered prices for more drugs — charging people in different countries different prices according to ability to pay and market size — the industry can also increase the number of people who are able to buy medicines, improving consumer welfare while retaining and even improving profit margins. It can work with its competitors and partners in nonprofit and government sectors to explore the practicality of public-private partnerships and the synergies that may come with them. The United Nations (UN), however, appears to want these companies to assume the responsibilities of government — a role with dubious legal and practical implications. If the UN and its supporters get their way, the long-term consequences for public health could be dire.

Corporate Responsibility in der forschenden Arzneimittelindustrie / Corporate Responsibility in the Research-Based Pharmaceutical Industry

Summary Corporate Responsibility is a crucial concept in the pharmaceutical industry, especially for research-based pharmaceutical companies. Companies are faced with a tension between fulfilling normative expectations of solidarity and making profits under the pressure of competition. We argue that the seemingly plausible strategy to realize corporate responsibility as corporate philanthropy is systematically misleading and, in the long run, undermining the legitimacy of the core business. Instead, pharmaceutical companies should demonstrate their corporate responsibility by investing in their licence to operate, that is, by preventing possible conflicts between profits and morals. This requires not only investments in governance structures but also the ability to communicate the legitimacy of making profits as well as their corporate integrity.

Affordable Antiretroviral Drugs for the Under-Served Markets: How to Expand Equitable Access Against the Backdrop of Challenging Scenarios?

Threats by enforced Intellectual Property (IP) rights to equitable HIV treatment access by poor populations are impending. India and China's policy directions in the field will be crucial in ultimately affecting the affordability and accessibility of antiretroviral (ARV) therapy in the under-served markets. These directions, together with the exploitation level of IP-bound flexibilities and the evolutionary modelling in partnerships and trade agreements between research-based and generic pharmaceutical industry, will also affect the outcomes of self-sufficiency efforts now at their beginning in the developing world as far as domestic manufacturing of generic ARV drugs is concerned. This paper explores key issues, implications and interaction dynamics across these challenging scenarios while attempting to provide equitable solution glimpses into the near future. Access-oriented long-term drug policy strategies entitled to pass muster of governments, research-based as well as generic industries in both developed and developing countries are needed if equitable access to affordable ARV treatments by poor people has to be achieved despite enforced IP rights. Predictable dynamics between western multinationals and transitional country generic corporations let regard IP-bound Voluntary License flexibilities as a fitting measure into just mentioned needs especially if substantial incentives to generic corporations are concurrently secured. Efforts to equitably expand ARV drug access through exploiting IP opportunities should encompass attainment of self-sufficiency in domestic drug manufacturing whenever basic requirements are in place in the developing world as a whole. A credible industrial potential would act, indeed, as a boosting factor for drawing branded drug producers into technology transfer agreements, the terms of which would let all contractors enjoy substantial advantages. These perspectives consistently bind up with the foreseeable long-term trade and drug policy directions of India and China according to frontier crossing implications of their key IP management trends as well as their multifaceted penetration strategies of both the wealthy and under-served markets worldwide. As coherent with these perspectives, more disbursement by wealthy country governments and donors to basic infrastructure development in sub-Saharan African nations with stable governments in place is urged both as a priority for improving Africa's economy and a prerequisite for allowing domestic industrial plants to take off. Aiming at the targets just underscored, WHO's brokering role in negotiated agreements between wealthy and developing country-based firms as well as its technical guidance in setting international standards have always to be sought if equitable and appropriate end results are to be attained. Overall insights in this paper would mean that, while research-based corporations are to be praised whenever waiving, on humanitarian purposes, part of their profits, the trade and profit rules cannot basically be given up if long-term sustainable results are the goal to look for. Only negotiated agreements securing all contracting parties lasting advantages may ensure shifting of such a goal from mere vision to a really sustainable attainment.

Commentary: A Merck Perspective on the Doha Round

Commentary on the Doha Development Round from a representative of Merck. Thomas Bombelles is Director, International Government Relations, for Merck & Co., Inc. His responsibilities include definition and advocacy on important international business and policy issues for the company focusing on government agencies and other institutions in Washington, DC. Prior to joining Merck, Bombelles was the Assistant Vice President International at the Pharmaceutical Research and Manufacturers of America (PhRMA), the professional association representing the American research-based pharmaceutical industry globally. He has also worked as a private sector consultant, as a trade analyst in the Department of Commerce, and in the US Congress. He received an M.A. degree from the Paul H. Nitze School of Advanced International Studies at Johns Hopkins University, and a B.A. degree from the honors program at the University of Michigan, Ann Arbor.

AIDS Policy and Pharmaceutical Patents: Brazil's Strategy to Safeguard Public Health

Developing nations are challenged to strike a balance between their patent obligations as members of the World Trade Organisation (WTO) and their drug pricing strategies. The Brazilian approach to pharmaceutical price negotiations has been strikingly effective. Describing the context of the Brazilian pharmaceutical sector, their public health system and the Brazilian AIDS policy, this paper examines the Brazilian strategy vis‐à‐vis the international pharmaceutical manufacturers to explore why their tactics were successful and the potential for wider application by other developing countries.

The Research-Based Pharmaceutical Industry and Society:

The Research-Based Pharmaceutical Industry and Society:

The Art and Science of Risk Management

The research-based pharmaceutical industry in the US strongly supports the concepts of risk management and sees formal risk management as playing a major role in the development of safe medicines for the public, as well as providing a mechanism to ensure that decisions concerning individual drug benefit and risk are made based on scientific evidence. Safe medicines refer to those drugs whose benefits have been found to outweigh their risks when they are used according to the approved labelling. Risk management is the comprehensive and proactive application of scientifically based methodologies to identify, assess, communicate and minimise risk throughout the life cycle of a drug so as to establish and maintain a favourable benefit-risk balance in patients. Although there are certainly a number of global risk management initiatives in place or being undertaken, harmonisation has yet to be achieved. Industry is faced with a variety of different risk management approaches and tools. There is a need to move the focus of risk management from the post-approval arena to earlier in the development process and tools need to be developed to support risk management throughout the lifecycle of a drug. The focus in the US on risk minimalisation strategies will also be an area for methodological development. A key factor in the success of overall risk management is the dialogue between industry and regulators throughout the development, review and marketing of the product. It is through such dialogue that appropriate, efficient and effective risk management strategies will be developed and implemented and the best decisions regarding the safe use of pharmaceutical products will be made.

The future of healthcare and the pharmaceutical industry – a CEO view

In the century or so since the birth of the research-based pharmaceutical industry, there has never been a more demanding time. The most pressing issue facing virtually all big pharmaceutical companies today is research and development productivity. Despite huge investments in research and development, the number of new medicines cleared for market has declined. On the other hand, there has never been a more exciting time to do healthcare research. New sciences and technologies are opening up radically new perspectives and opportunities for the future. Medical practice is undergoing a historic shift towards more personalized medicine. Over the next 10 years we can expect significant progress in the treatment of major diseases.