Pharmaceutical Licensing Research Articles

Regulation of pharmaceutical licensing on the example of the European Union countries

Regulation of pharmaceutical licensing on the example of the European Union countries

Balancing Pharmaceutical Innovation and the Chinese Public Interest: A Comparative Research of Compulsory Pharmaceutical Licensing Systems

Balancing Pharmaceutical Innovation and the Chinese Public Interest: A Comparative Research of Compulsory Pharmaceutical Licensing Systems

Compulsory Licensing of Pharmaceuticals in High-Income Countries: A Comparative Analysis.

Compulsory licensing is a practice whereby national authorities can license a third party to produce a patented product, such as a pharmaceutical drug, effectively enabling the production of a generic before the original patent expires. The policy was designed-and has historically been used-to improve access to essential medicines in low-income countries and during public health crises. Although it was not intended to impact drug prices directly, the threat of compulsory licensing may indeed contribute to lower drug prices in high-income countries outside the United States. Our study sought to determine the plausibility of this claim. We compiled a comprehensive database of compulsory licensing episodes in the United States and 17 comparator nations over the 20 years following the 2001 Doha Declaration, and we recorded the motivation and outcome of each instance. Our search began with publicly available reports compiled by organizations specializing in pharmaceutical intellectual property, expanded to a query of legal proceedings in Westlaw, and concluded with a comprehensive literature review on PubMed. This strategy yielded 45 unique episodes of compulsory licensing, 24 in the United States and 21 outside. A minority (24%) of petitions outside the United States were motivated by high prices, and in all countries, only three cases were clearly associated with a price discount. We found no evidence to suggest that compulsory licensing is either frequently threatened or successfully implemented by countries outside the United States to secure price discounts for the most expensive pharmaceuticals, those that are newly patented and just entering the market.

Pharmaceutical Company In-house Research and Licensing Transaction Review

Background:​ Pharmaceutical in-house research and licensing deals are effective means of widespread production of drugs to the public. These transactions follow a normalized procedure requiring upfront payments between a buying company to work either collaboratively with a small to medium sized selling company or buying the right of a product completely. Licensing a novel pharmaceutical drug goes through several clinical phases, and transaction deals can involve royalty and/or milestone payments along the research and clinical trial process. Methods​: Data was collected through analysis of pharmaceutical licensing market deals via online databases and extracted to a data sheet for examination. Trends were highlighted after analyzing upfront payment values, royalty sales, milestone payments and total transaction deal value. Results​: Total milestone payments averaged at USD $639.1 million, and total royalty payments averaged at USD $899.77 million. Average total deal values is USD $1445.18 million. Correlation coefficients between: (1) upfront and milestone payments r = 0.155; (2) upfront payments and royalty payments r = 0.188; and (3) upfront payments and total deal value r = 0.604. Most transactions are a small/medium enterprise selling to big pharmaceutical companies (32%) or a big pharmaceutical company selling to a small/medium enterprise (32%). 27% of deals are between big pharmaceutical companies, and 9% of deals are between small/medium enterprises. Conclusion:​ There is a positive correlation between upfront payment costs with milestone/royalty costs and total deal value (n=25). Small or medium enterprises are beginning to take a large sector of the transaction business as their in-house research licensing grows more appealing for market distribution.

An evaluation of physiotherapy-led inhalation testing in chronic respiratory disease at a tertiary centre

Background Inhaled medications improve health outcomes in chronic respiratory patients. Guidelines and pharmaceutical licensing agreements recommend a drug response trial prior to use. Evidence to support this recommendation is of poor quality; adverse events are rare, and the trial process has a considerable impact on physiotherapy clinical time and patient experience. Current literature suggests using percentage predicted forced expiratory volume in 1 second (FEV1) >55% as a predictor of trial success. Aims 1. To identify the failure rate of inhaled therapy trials in the chronic respiratory cohort. 2. To predict risk factors associated with trial outcome to establish those who could avoid a trial due to low risk stratification. Methods An evaluation of service was completed which involved a retrospective review of 204 chronic respiratory participants who completed an inhaled therapy trial between September 2017 and September 2019. Spirometry and other anthropometric measurements were recorded at the time of the drug response trial. Data was analysed using multivariable logistic regression to identify variables linked to passing inhaled therapy trials. Discussion and conclusion FEV1% predicted was significantly less for those that failed (35.5%) compared to those that passed (53.18%) p = 0.012. Those with an FEV1 predicted >55% had a higher likelihood to pass p = 0.005, R² = 0.039. The evaluation identified a low failure rate (4.9%) overall to inhalation therapy trials, with the most significant risk factor for failure being identified as FEV1 predicted <55%. Patient screening could significantly reduce the burden of inhaled therapy trials for patients

Corruption and COVID-19

The coronavirus pandemic has created incentives for corruption, fraud, and self-dealing that can be explained by the underlying political-economic incentives at work. Three characteristics of the COVID-19 crisis are especially important. First, the rapidly unfolding pandemic and the accompanying economic recession have led to fierce competition for essential resources. Second, governments have rapidly mobilized public funds (for both healthcare and economic stabilization) at an unprecedented scale, creating opportunities for rent-seeking of many kinds, including outright corruption. Third, politicians, bureaucrats and medical professionals exercise substantial discretion in the allocation of resources. A lack of transparency and weak oversight and enforcement have exacerbated the problems of corruption and fraud, and public measures against these offenses have not kept pace with the developing crisis. The paper discusses how these features interact in procurement processes, in government assistance to individuals and businesses, and in the development and licensing of pharmaceuticals. Those who benefit from corruption, be they contractors or individuals, will emerge from the pandemic better off than before it started if governments do not act. Tolerance of malfeasance will be at the expense of long-term government legitimacy and spread the virus to the most vulnerable. The need for a speedy response to the pandemic should not be an excuse for undermining institutions that strengthen governmental integrity.

Proposed Title of the Project: Should China Implement Compulsory Drug Patent Licenses? - From the Perspective of COVID-19

<p>Although China has already issued laws and regulations on compulsory licensing of pharmaceutical patents, it has not yet implemented specific practices. After the outbreak of “COVID-19”, realistic needs have made it urgent for China to implement compulsory drug patent licensing. Therefore, this study will be based on China’s national conditions, combined with China’s laws and regulations on the compulsory licensing of pharmaceutical patents, and compare specific practices in other countries. Through qualitative analysis, it’s clear that China implements compulsory pharmaceutical patent licensing in three aspects: domestic system, international level, and government responsibility. To analyze the feasibility of China’s drug patent compulsory licensing system and provide suggestions.</p>

Regulation, innovation and disruption: the European Medicines Agency and adaptive licensing of pharmaceuticals

ABSTRACT Growing concerns over the related problems of speedily bringing innovative pharmaceuticals (especially so-called precision medicines) to market, and addressing areas of unmet medical need, have engendered critical scrutiny of the existing process for the licensing of pharmaceutical products. The objective is to enable these products to receive approval sooner, but on the basis of the provision of less complete evidence, than was previously the case. This article examines the attempts made to tackle this issue at European Union level, through a pilot programme exploring ‘adaptive’ approaches to licensing operated by the European Medicines Agency. Responses to this initiative indicate significant difficulty in securing regulatory legitimacy in this context. This suggests that innovative pharmaceutical technologies are disruptive of existing regulatory frameworks, such that future attempts to accommodate them within these may be susceptible to failure.

Challenges to sovereign ambitions: forces of convergence and divergence within the global pharmaceutical sector and the UK's withdrawal from the European Union.

This paper maps key regulatory, governance and legal challenges associated with the UK's withdrawal from the European Union (EU) in terms of convergent and divergent pressures within the global pharmaceutical sector. These include (i) convergent regulatory pressures associated with the European framework for pre-market licensing; (ii) convergent and divergent industry pressures with regard to drug discovery and manufacturing; and (iii) divergent and convergent market pressures associated with the supply, pricing and assessment of medicines. The UK's sovereign ambitions risk a loss of influence over the licensing and surveillance of pharmaceuticals under convergent regulatory and industry pressures to engage in unilateral participation in the European regime. Further, they also risk a loss of influence over processes for pricing and assessing the effectiveness of new treatment regimens under divergent market pressures from larger pharmaceutical markets outside the EU, notably the United States.

Importance of the intellectual property system in attempting compulsory licensing of pharmaceuticals: a cross-sectional analysis

BackgroundRecently, interest in compulsory licensing of pharmaceuticals has been growing regardless of a country’s income- level. We aim to investigate the use of compulsory licensing as a legitimate part of the patent system and tool for the government to utilize by demonstrating that countries with a mature patent system were more likely to utilize compulsory licensing of pharmaceuticals.MethodsWe used a multivariate logistic model to regress attempts to issue compulsory licensing on the characteristics of the intellectual property system, controlling for macro context variables and other explanatory variables at a country level.ResultsA total 139 countries, selected from members of the World Trade Organization, were divided into a CL-attempted group (N = 24) and a non-CL-attempted group (N = 115). An attempt to issue compulsory licensing was associated with population (+) and a dummy variable for other regions, including Europe and North America (−). After controlling for macro context variables, mature intellectual property system was positively associated with attempting compulsory licensing.ConclusionsOur study provided evidence of an association between attempting compulsory licensing and matured patent systems. This finding contradicts our current understanding of compulsory licensing, such as compulsory licensing as a measure to usurp traditional patent systems and sometimes diametrically opposed to the patent system. The findings also suggest a new role of compulsory licensing in current patent systems: compulsory licensing could be a potential alternative or complement to achieve access to medicines in health systems through manufacturing and exporting patented pharmaceuticals.

How Much Time Before Attempting Compulsory Licensing of Pharmaceuticals? A Non-parametric Event History Model With P-splines

Compulsory licensing (CL), provided by the Agreement on Trade-Related Aspects of Intellectual Property Rights, enables countries, including high-income countries, to ensure the protection of public health in the context of stringent intellectual property regimes. This study investigated associations between the time to attempted CL and a series of factors at the drug and country level. We used a dataset of all attempted CL that occurred from 1995 to 2014, calculated the duration as the difference in years between the year of global marketing of a certain drug and the year of attempted CL in a certain country, and applied a nonparametric event history model. We found that the Doha Declaration was quite effective in shortening the time to attempted CL. Additionally, even though global justice movements have encouraged some countries to attempt CL for various medicines since 2012, the time to CL attempts in this period became significantly longer compared to those that occurred immediately after the Doha Declaration. Our findings show that the subject of CL has not successfully expanded to oncology medicines from HIV/AIDS medicines and that recently approved medicines are not yet subjects of CL. Furthermore, our duration model suggests a learning-by-doing effect in attempting CL: previous experience of CL not only triggers CL for the same drugs in other countries but also accelerates CL for other drugs within the country.

Differentiation of innovation strategies based on pharmaceutical licensing agreements: Insight from Korean pharmaceutical firms

ABSTRACTThe paper aims to show how licensing behaviour can be used to differentiate distinct innovation strategies. Information on in-licensing and out-licensing agreements is used to guide the development of a framework that details the licensing firm’s relational preference for internal and external orientation. Using firm-level data of the Korean pharmaceutical firms, the study categorised the distinct strategic orientations of firms based on the proposed matrix model. The results indicated that firms with higher R&D (research and development) expenditures have a tendency to greater external exploitation of technological knowledge than firms with low R&D spending. The study provides potential avenues for targeting of licensing partners from the perspective of firms seeking to in-license or out-license their innovations.

Understanding of for whom, under what conditions and how the compulsory licensing of pharmaceuticals works in Brazil and Thailand: A realist synthesis

ABSTRACTWhen pharmaceuticals are not fully available mainly due to the high cost of medicines, a government can issue compulsory licensing (CL). It is well documented that Brazil and Thailand have notably attempted CL. A realist review was undertaken to understand the identical social interventions in comparative settings, and to draw practical implications for attempting CL relevant for middle-income countries in the era of high-cost medicines. CL is not only a politically well-devised measure to achieve universal health coverage, but also a tentative commitment, which is determined both at the country level and at the global level. At the country level, political will, with catalytic roles of civil activism, is important in order to guarantee the right to health. Through this will, the governments can achieve universal health coverage. In addition, electoral systems, political leaders, and a constitution are necessary to attempt CL. In addition, CL should operate along with other policy instruments, including a comprehensive essential medicines list, CL-friendly phrasing in patent law, and a competent pharmaceutical industry. At the global level, the balance of power between the WTO regime and the global justice movement is critical. This provides global-level context that can either encourage or prevent CL.

Diagnosis of the main problems in the field of intellectual resources management in pharmacy

In the conditions of innovative pharmacy development the problem of theoretical and scientific-practical approaches to intellectual resources management of drug developers and manufacturers becomes of a particular urgency.Aim. To diagnose the main problems in the field of intellectual resources management in pharmacy and to identify the reserves for improving the efficiency of their use.Materials and methods. In the context of our future work we had also devised a special questionnaire in order to propose and to work out by experts. The experts were specialists with practical experience in pharmacy and sufficient experience in the field of innovation and science: scientific staff of Higher Educational Establishments, research organizations, heads and specialists of pharmaceutical companies (FC), patent and licensing services, etc. Results. A detailed analysis, which was conducted by competent experts, has established the main problems of intellectual resources management in the domestic pharmacy at the macro, industry and micro levels. It has proved that at macro and industry level, implementation of the state innovation policy in order to attract foreign and domestic investments for the financing of fundamental research is necessary to obtaining new scientific results, the creation of competitive drugs, as well as the development of concepts and programs are aimed at on the development and regulation of innovation in pharmacy; the use of modern intellectual resources management strategies that are widely used by foreign pharmaceutical companies (the creation of biopharmaceutical clusters, strategic alliances for the implementation of high-value innovation projects, the development of public-private partnerships, etc.). At the micro level strategic directions in the field of intellectual resources management have established: increase of innovation activities in universities, research institutions, pharmaceutical companies; introduction of modern mechanisms of intellectual activity commercialization; formation of intangible assets register as a strategic resource for increasing the competitiveness of the organization.Conclusions. Using cause-and-effect relationship Ishikawa diagram the potential reserves of intellectual resources (structural, human, market) management in pharmacy have generalized. Each of the presented reserves performs certain tasks and only in aggregate they provide the main goal – improving the intellectual resources management in pharmacy.

Compulsory licensing of pharmaceuticals reconsidered: Current situation and implications for access to medicines

ABSTRACTTo examine patterns and trends in attempts, distinguished from issuance, to issue compulsory licensing of pharmaceuticals and to assess related implications in the era of high-cost medicines. Documents from various civil society organisations were primarily used to search attempts, as well as published literature. The identified attempts were analysed by pharmaceutical level, national level, claimers, and the outcomes of the attempts. There have been 108 attempts to issue compulsory licensing for 40 pharmaceuticals in 27 countries since 1995. Most of the attempts were in Asian, Latin American, and African countries and mainly for HIV/AIDS medicines. Moreover, when the claimer was the government, the likelihood of approval and positive outcomes increased. Compulsory licensing, which was devised to cope with the HIV/AIDS pandemic in low-income countries, became a practical measure in several Asian and Latin American countries, even for non-HIV/AIDS medicines. Resurgent compulsory licensing in 2012 and 2014, influenced by the global justice movement, might represent a policy window in the near future as the Doha Declaration did in the 2000s. In this context, various experiences should be circulated and analysed at the global level to better understand the circumstances under which successful issuance has been achieved at the country level.

Compulsory licensing of pharmaceuticals by the developing south

Compulsory licensing (CL) of medicines by a developing South unambiguously improves access to treatments by its population. Its impact on profits and thus innovation rates and welfare is a more controversial issue in the literature. This paper proposes a North–South model dealing with parallel trade, price controls and compulsory license (if the South is not served). Our results challenge the literature claiming that parallel trade leads to higher innovation and welfare. Moreover, conditions apply for CL to be used; in particular, it should never be used for neglected diseases, as malaria and tuberculosis. When the South issues CLs, it is compensated for the welfare losses caused by the North allowing parallel trade, and innovation and northern welfare do not decrease. The best outcome, however, is market segmentation, i.e. no parallel trade in the first place.

PP109 Horizon Scanning For Information Providing In Brazil

INTRODUCTION:The last five years represented an advanced season for the establishment and reinforcement of the Brazilian Ministry of Health's Horizon Scanning System. The recognition of Horizon Scanning (HS) as a tool for evidence- based decision making has been reflected in the requests for information directed to the Horizon Scanning's team. These requests for information about new and emerging technologies come from cabinets offices and thematic departments of the Ministry of Health. The methodology of Horizon Scanning assessments described in EuroScan's toolkit1 has been applied to guarantee that the information reach stakeholders at the right time. The National Committee for Health Technology Incorporation (CONITEC) was accepted as a member of EuroScan (1) in 2016, and this represented another important step of Brazil's HS System.METHODS:In order to provide the specific information requested, the assessments of the technologies are done. So, databases on ongoing clinical trials, commercial pharmaceutical database, registration and licensing sites, proceedings and abstracts of scientific conferences and scientific databases are checked to collect the information. The extent and depth of the assessments depends on the stakeholders needs and time available to complete them. However, information as how the technology works, the clinical burden of disease, if there are available technologies in the Brazilian Public Health System to treat the disease, safety and effectiveness data, the regulatory status in the world as well costs, social, ethical and legal concerns are commonly given.RESULTS:The information provided using the HS methodology is used by stakeholders for several purposes as to defend the Ministry of Health in the Courts in the typical Latin American phenomena called “judicialization of health;” in assistance of the decision making of incorporation of technologies by the Brazilian Public Health and to support the definition of which medicines would be more strategic for establishment of Public-private partnerships for development of medicines, the named “Productive Development Partnerships (PDPs)”.CONCLUSIONS:The assessment of the technologies and the prediction of its potential for impact has helped the health policy making process in Brazil.

Notable licensing deals in the biopharma industry in the second quarter of 2017.

During the second quarter of 2017, Cortellis Competitive Intelligence added 967 new licensing deals (excluding mergers and acquisition deals) as part of its ongoing coverage of pharmaceutical licensing activity. This meant an 8% decrease on the previous quarter (1,050) and a 3% decrease from the same quarter in 2016 (993). This quarter also showed a significant decline in the number of deals worth more than USD 0.5 billion from the last quarter (7 vs. 17). This article will highlight a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers in the life sciences. An update on milestone, options and terminated deals of significance will also be presented, along with an early outlook on the next quarter's pharmaceutical licensing activity.

Notable deals in the pharmaceutical industry in the first quarter of 2017.

During the first quarter of 2017, Cortellis Competitive Intelligence had 1,073 new deals added as part of its ongoing coverage of pharmaceutical licensing activity. This meant a slight increase on the last quarter (1,022) and a similar volume on the same quarter for the previous 1 year (1,141). However, this quarter showed a significant augment in deals worth more than USD 0.5 billion on the last quarter (17 vs. 12). This article will focus on highlighting a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers. An update on milestone, options and terminated deals of significance will also be presented, along with an early outlook on the next quarter's pharmaceutical licensing activity.

Notable licensing deals in the biopharma industry in the third quarter of 2017.

During the third quarter of 2017, Cortellis Competitive Intelligence registered 949 new deals (excluding mergers and acquisitions) added as part of its ongoing coverage of pharmaceutical licensing activity compared to 1,007 in Q2 this year and 1,023 in Q3 the previous year.