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1.
Surg Endosc ; 36(5): 3340-3346, 2022 May.
Article in English | MEDLINE | ID: covidwho-1787817

ABSTRACT

INTRODUCTION: The protection of intellectual property (IP) is one of the fundamental elements in the process of medical device development. The significance of IP, however, is not well understood among clinicians and researchers. The purpose of this study was to evaluate the current status of IP awareness and IP-related behaviors among EAES members. METHODS: A web-based survey was conducted via questionnaires sent to EAES members. Data collected included participant demographics, level of understanding the need, new ideas and solutions, basic IP knowledge, e.g., employees' inventions and public disclosure, behaviors before and after idea disclosures. RESULTS: One hundred and seventy-nine completed forms were obtained through an email campaign conducted twice in 2019 (response rate = 4.8%). There was a dominancy in male, formally-trained gastrointestinal surgeons, working at teaching hospitals in European countries. Of the respondents, 71% demonstrated a high level of understanding the needs (frustration with current medical devices), with 66% developing specific solutions by themselves. Active discussion with others was done by 53%. Twenty-one percent of respondents presented their ideas at medical congresses, and 12% published in scientific journals. Only 20% took specific precautions or appropriate actions to protect their IPs before these disclosures. CONCLUSIONS: The current level of awareness of IP and IP-related issues is relatively low among EAES members. A structured IP training program to gain basic IP knowledge and skill should be considered a necessity for clinicians. These skills would serve to prevent the loss of legitimate IP rights and avoid failure in the clinical implementation of innovative devices for the benefit of patients.


Subject(s)
Intellectual Property , Surgeons , Europe , Humans , Male , Publications , Surveys and Questionnaires
2.
Lancet ; 399(10332): 1292-1293, 2022 04 02.
Article in English | MEDLINE | ID: covidwho-1768615
6.
Yakugaku Zasshi ; 142(1): 75-84, 2022 Jan 01.
Article in Japanese | MEDLINE | ID: covidwho-1599886

ABSTRACT

The spread of COVID-19 has re-affirmed the crucial importance of the pharmaceuticals industry in improving the level of citizens' health and medical care, as well as the industry's importance in terms of contribution to economic growth and tax revenues. Although some time has passed since the importance of industry-academia collaboration was first raised in relation to the creation of innovative new drugs and the continuation of global competitiveness, conflicts between academia and companies have also been highlighted as barriers that hinder efforts to promote the practical realization of academia-initiated seeds. The authors have hypothesized that conflicts between academia and companies can be attributed to the vulnerability of innovation creation environments, including drug discovery, on the academia side, insufficient awareness concerning human resources that will undertake industry-academia operations, and inadequate development of structures. Consequently, we implemented fact-finding investigations in relation to universities and public research institutions in Japan, with the objective of ascertaining the actual status of innovation creation environments, including drug discovery, on the academia side. From the results of these investigations, we will clarify the issues that may present barriers to innovation creation, and consider policies, etc. for the enhancement of innovation creation environments.


Subject(s)
Academies and Institutes , COVID-19 , Drug Discovery , Drug Industry , Intellectual Property , Intersectoral Collaboration , Humans , Universities , Workforce
7.
Methods Mol Biol ; 2412: 505-518, 2022.
Article in English | MEDLINE | ID: covidwho-1588850

ABSTRACT

Over the past 20 years, there has been steady, year-on-year growth in the number of granted vaccine-related patents. It is therefore important that those involved in vaccine research should be aware of both the risks and opportunities that patents create. The aim of this chapter is to offer a brief introduction to how, and when, patent rights might become available to vaccine developers and to explain the potential risk of infringement of third-party patent rights and the potential consequences.This chapter begins with a brief introduction to the patent application process and the international patent systems. The advantages and drawbacks of patent protection are discussed, followed by an overview of patent infringement and the various legal safe-harbors that may be available for certain research activities. Other features of the patent system which may be of particular relevance in the vaccines context are also discussed, such as compulsory licensing, sovereign states' rights to use patented inventions and voluntary technology sharing agreements. The chapter concludes with a discussion of the SARS-CoV-2 (COVID-19) pandemic and recent developments in the field of vaccine patents that have arisen as part of the international response.


Subject(s)
Intellectual Property , Vaccines , COVID-19 , Humans , Inventions , SARS-CoV-2
9.
Drug Discov Today ; 27(2): 384-389, 2022 02.
Article in English | MEDLINE | ID: covidwho-1491950

ABSTRACT

Proposals to waive intellectual property rights (IPRs) on coronavirus 2019 (COVID-19)-related developments have gained considerable support among politicians, including from US President Biden, academics, nongovernmental organizations (NGOs), the media, and the general public. However, there are surprisingly few reflections about the short- and long-term consequences for medical innovation, particularly the development of new drugs and vaccines. In this feature, I reflect on the consequences for innovative entrepreneurial companies, the incentives to innovate, and consequences for international knowledge flows to low- and middle-income countries. I conclude that waiving IPRs reduces opportunities for entrepreneurial companies to attract sufficient funding for developing medical innovations. Low- and middle-income countries might suffer reduced knowledge inflows in the absence of IPRs that undermine their ability to develop medical innovations.


Subject(s)
Drug Discovery , Drug Industry/trends , Intellectual Property , Antiviral Agents/pharmacology , Antiviral Agents/therapeutic use , COVID-19/drug therapy , COVID-19 Vaccines/therapeutic use , Developing Countries , Drug Industry/legislation & jurisprudence , Humans
10.
Lancet Public Health ; 7(2): e169-e176, 2022 02.
Article in English | MEDLINE | ID: covidwho-1483035

ABSTRACT

BACKGROUND: Non-exclusive voluntary licensing that is access-oriented has been suggested as an option to increase access to medicines to address the COVID-19 pandemic. To date, there has been little research on the effect of licensing, mainly focused on economic and supply chain considerations, and not on the benefits in terms of health outcomes. We aimed to study the economic and health effect of voluntary licensing for medicines for HIV and hepatitis C virus (HCV) in low-income and middle-income countries (LMICs). METHODS: A robust modelling framework was created to examine the difference between scenarios, with (factual) and without (counterfactual) a Medicines Patent Pool (MPP) licence for two medicines, dolutegravir and daclatasvir. Data were obtained from MPP licensees, as well as a large number of external sources. The primary outcomes were the cost savings and health impact between scenarios with and without MPP licences across all LMICs. Through its licences, MPP had access to the volumes and prices of licensed generic products sold in all covered countries on a quarterly basis. These data informed the volumes, prices, and uptake for the past factual scenarios and were the basis for modelling the future factual scenarios. These scenarios were then compared with a set of counterfactual scenarios in the absence of the studied licences. FINDINGS: Cumulatively, between 2017 and 2032, the model's central assumptions predicted an additional uptake of 15·494 (range 14·406-15·494) million patient-years of dolutegravir-based HIV treatments, 151 839 (34 575-312 973) deaths averted, and US$3·074 (1·837-5·617) billion saved through the MPP licence compared with the counterfactual scenario. For daclatasvir-based HCV treatments, the cumulative effect from 2015 to 2026 was predicted to be an additional uptake of 428 244 (127 584-636 270) patients treated with daclatasvir, 4070 (225-6323) deaths averted, and $107·593 (30·377-121·284) million saved with the licence compared with the counterfactual scenario. INTERPRETATION: The chain of effects linking upstream licensing to downstream outcomes can be modelled. Accordingly, credible quantitative estimates of economic and health effects arising from access-oriented voluntary licensing were obtained based on assumptions that early generic competition leads to price reductions that influence procurement decisions and enable the faster and broader uptake of recommended medicines, with beneficial economic and health effects. FUNDING: Unitaid.


Subject(s)
COVID-19/drug therapy , Developing Countries , Intellectual Property , Licensure/economics , Prescription Drugs , Public Health/economics , SARS-CoV-2 , Economic Competition , Humans , Outcome Assessment, Health Care
11.
Yakugaku Zasshi ; 142(1): 75-84, 2022 Jan 01.
Article in Japanese | MEDLINE | ID: covidwho-1463294

ABSTRACT

The spread of COVID-19 has re-affirmed the crucial importance of the pharmaceuticals industry in improving the level of citizens' health and medical care, as well as the industry's importance in terms of contribution to economic growth and tax revenues. Although some time has passed since the importance of industry-academia collaboration was first raised in relation to the creation of innovative new drugs and the continuation of global competitiveness, conflicts between academia and companies have also been highlighted as barriers that hinder efforts to promote the practical realization of academia-initiated seeds. The authors have hypothesized that conflicts between academia and companies can be attributed to the vulnerability of innovation creation environments, including drug discovery, on the academia side, insufficient awareness concerning human resources that will undertake industry-academia operations, and inadequate development of structures. Consequently, we implemented fact-finding investigations in relation to universities and public research institutions in Japan, with the objective of ascertaining the actual status of innovation creation environments, including drug discovery, on the academia side. From the results of these investigations, we will clarify the issues that may present barriers to innovation creation, and consider policies, etc. for the enhancement of innovation creation environments.


Subject(s)
Academies and Institutes , COVID-19 , Drug Discovery , Drug Industry , Intellectual Property , Intersectoral Collaboration , Humans , Universities , Workforce
13.
Am J Law Med ; 47(2-3): 157-175, 2021 07.
Article in English | MEDLINE | ID: covidwho-1361581

ABSTRACT

The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.1 Inarguably, significant problems with the multi-faceted system of drug and vaccine innovation and regulation manifested long before the COVID-19 pandemic.2 The pandemic, however, has laid bare the inextricable connections among federal funding, patents, product review and approval mechanisms, and the eventual medical products and resulting costs.


Subject(s)
Biological Products/economics , COVID-19/drug therapy , Drug Approval/legislation & jurisprudence , Government Agencies , Patents as Topic , Therapies, Investigational/economics , Humans , Information Dissemination , Intellectual Property , Research Support as Topic , SARS-CoV-2 , United States
15.
Recenti Prog Med ; 112(7): 499-503, 2021.
Article in Italian | MEDLINE | ID: covidwho-1311322

ABSTRACT

Access to vaccines against covid-19 is a very topical issue. On the one hand, we are suffering from supply problems and inadequate availability of doses both nationally and internationally. On the other hand, public health needs do not coincide with those of the market economy: the need to vaccinate the entire world population to overcome the pandemic cannot be satisfied due to market rules and limits in production processes. The result is a radical inequality in access to vaccines. We are aware of the delicate balance between health and economy: the latter cannot ignore the former. Also for this reason, the demand for greater equity in access to vaccines is growing: the race for innovation may not be hindered by a targeted relaxation of the rules on intellectual property during a pandemic health emergency.


Subject(s)
COVID-19 Vaccines/supply & distribution , COVID-19/prevention & control , Drug Development , Intellectual Property , Biomedical Research/economics , COVID-19 Vaccines/economics , Diffusion of Innovation , Global Health , Healthcare Disparities , Humans , Italy , Needs Assessment , Patents as Topic , Public Health , Research Support as Topic/economics , Vaccination Coverage
17.
BMJ Glob Health ; 6(7)2021 07.
Article in English | MEDLINE | ID: covidwho-1307894

ABSTRACT

The recent rapid development of COVID-19 vaccines offers hope in addressing the worst pandemic in a hundred years. However, many countries in the Global South face great difficulties in accessing vaccines, partly because of restrictive intellectual property law. These laws exacerbate both global and domestic inequalities and prevent countries from fully realising the right to health for all their people. Commodification of essential medicines, such as vaccines, pushes poorer countries into extreme debt and reproduces national inequalities that discriminate against marginalised groups. This article explains how a decolonial framing of human rights and public health could contribute to addressing this systemic injustice. We envisage a human rights and global health law framework based on solidarity and international cooperation that focuses funding on long-term goals and frees access to medicines from the restrictions of intellectual property law. This would increase domestic vaccine production, acquisition and distribution capabilities in the Global South.


Subject(s)
COVID-19 , Vaccines , COVID-19 Vaccines , Health Services Accessibility , Human Rights , Humans , Intellectual Property , SARS-CoV-2
19.
J Med Ethics ; 47(9): 595-598, 2021 09.
Article in English | MEDLINE | ID: covidwho-1301667

ABSTRACT

This paper gives an ethical argument for temporarily waiving intellectual property (IP) protections for COVID-19 vaccines. It examines two proposals under discussion at the World Trade Organization (WTO): the India/South Africa proposal and the WTO Director General proposal. Section I explains the background leading up to the WTO debate. Section II rebuts ethical arguments for retaining current IP protections, which appeal to benefiting society by spurring innovation and protecting rightful ownership. It sets forth positive ethical arguments for a temporary waiver that appeal to standing in solidarity and holding companies accountable. After examining built-in exceptions to existing agreements and finding them inadequate, the paper replies to objections to a temporary waiver and concludes, in section III, that the ethical argument for temporarily waiving IP protection for COVID-19 vaccines is strong.


Subject(s)
COVID-19 Vaccines , COVID-19 , Dissent and Disputes , Humans , Intellectual Property , SARS-CoV-2
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