Clinical Data and Disclosure Policies
The European Union, Member States, and International Best Practices
Pugatch Consilium, in partnership with the US Chamber’s Global Intellectual Property Center, releases Clinical Data and Disclosure Policies: The European Union, Member States, and International Best Practices. This report provides an exhaustive analysis of the clinical data transparency aspects of EU Parliament Regulation 536/2014 on clinical trials and EMA’s finalized policies on Publication and Access to Clinical Trials Data, as well as a review of the wider policy implications and interface of these policies vis-á-vis current data disclosure policies at five EU countries: Germany, Italy, Spain, Sweden, and the U.K.
How to stay one step ahead of an outbreak
Pugatch Consilium’s Prof. Meir Pugatch and Rachel Chu publish an article in fDi Magazine (http://www.fdiintelligence.com) on how building an innovation culture can help countries prepare for the outbreak of diseases such as Ebola. The article is part of Pugatch Consilium’s ongoing analysis and intelligence database on biopharmaceutical investment and innovation policy.
GIPC International IP Index
Pugatch Consilium, in partnership with the US Chamber’s Global Intellectual Property Center, released the third edition of the annual GIPC International IP Index. The 2015 edition of the Index, entitled UP: Unlimited Potential, maps the intellectual property environment in 30 economies. Overall, although challenges remain across the board, positive steps are being taken in many of the economies included in the Index. In fact, 20 of the economies mapped in 2014 improved their scores in the 2015 edition. The report also underscores the benefits experience by countries as they strengthen their IP environments in a special section that correlates the GIPC Index scores with 15 variables reflecting key economic activities.
Developing a Culture of Pharmacovigilance
New Report On the Monitoring of Safety of Medicines
Pharmacovigilance is the name given to the mechanisms and tests that together map and ensure the safety of a medicine throughout its life span – from test tube to patient. As patients and healthcare professionals around the world access and use more biopharmaceutical products and technologies, the importance of maintaining and, in many cases, introducing and applying comprehensive pharmacovigilance regulations only increases.
Scaling Up Global Clinical Trial Activity
Key Trends and Policy Lessons
This report explains and quantifies key factors for attracting investment in clinical research. The report also benchmarks performance in the level and scope of clinical trial activity, providing a “who’s who” in global clinical research among countries and biopharmaceutical companies.
Pugatch Consilium’s latest study uses regression analysis of data on 50 countries to provide a roadmap for creating a policy environment that is conducive to clinical trials – a fundamental component of making safe and effective medicines available.
An excerpt of the study is available for download. To request a full copy of the study please email: email@example.com
The Creative Industries and the BRICS
A review of the state of the creative economy in Brazil, Russia, India, China and South Africa
This review examines the state of the creative economy in the biggest emerging economies in the world namely Brazil, Russia, India, China and South Africa – the BRICS. Although at different levels of development, these economies are in many ways undergoing similar transitions from economies based on manufacturing, industrial output and natural resources to economies in which economic activity is based on innovation and creativity.
Building the Bioeconomy
Examining National Biotechnology Industry Development Strategies
This paper provides an overview of national innovation strategies, policies and best practices that relate to the building of a world-class biotechnology sector. It identifies key enabling policy input factors ranging from human capital, protection of intellectual property to infrastructure for research and development.
The Value of Cross-Border Data
The Value of Cross-Border Data to Consumers, Companies and Governments
The report considers the value and applications of cross-border data in different countries around the world today. It analyzes a wide range of personal, social and economic benefits using case studies and anecdotes as well as statistical analysis. The report also presents a set of enabling and deterrent factors of these flows.
A Scenario Analysis of Pharmaceutical Innovation and Access to Medicines in Europe
What does the process of creating these scenarios tell us about the approach that the pharmaceutical industry might choose to take to its interactions with policymakers both now and into the future?
Considering two distinct scenarios – “Suspicious Minds” and “Convergence” – this report explores the possible evolution of pharmaceutical innovation, access and financing of medicines in Europe, over a period of 10 years.
The GIPC Index highlights both improvements and impediments to creating robust IP environments.
In the 21st century, nations continue to look for the best policies to promote innovation, create jobs, and attract investment. The second edition of the GIPC Index provides an academically-rigorous guide for all countries to improve their IP environment and help chart a course to prosperity.
Direct link to the report can also be found on the GIPC Website (U.S. Chamber of Commerce).
Clinical Trials and Data Transparency
The Public Interest Case
Objective: The public and scientific community obtain increased access to enhance knowledge about medical advancements and regulatory accountability without compromising personal privacy or long-term incentives for biopharmaceutical R&D.
Scope: Personal data and CCI receive special treatment; all other data submitted to the EMA following the introduction of the draft policy will be proactively published.
Scientific American – World View: Does Your Country Deserve Investment From Biopharma?
An ongoing survey of executives and a resulting country index will reveal who is ready to compete for capital.
The BCI (Biopharmaceutical Competitiveness & Investment) is a global survey-based instrument translated to quantifiable index with a Bottom-up approach: relies on the expertise and experience of local executives; provides “On the ground” perspective of countries’ attractiveness to biopharmaceutical investment and enhances understanding of where national improvements are needed.
Biopharmaceutical Competitiveness & Investment (BCI) Survey
How attractive is your country for investment? Ask the experts
The BCI is a global survey-based instrument translated to quantifiable index with a Bottom-up approach: relies on the expertise and experience of local executives; provides “On the ground” perspective of countries’ attractiveness to biopharmaceutical investment and enhances understanding of where national improvements are needed.
Assembling the Pharmaceutical R&D Puzzle for Needs in the Developing World
An assessment of new and proposed delinking initiatives aimed at encouraging R&D into neglected and tropical diseases and specific Type II diseases.
London Declaration on Neglected Tropical Diseases
What does the “London Declaration on Neglected Tropical Diseases” reveal about research and development efforts into neglected and tropical diseases?
Gates Foundation, USAID, DfID, the WHO, DNDi, the Governments of Mozambique, Tanzania, Brazil and a host of multinational biopharmaceutical manufacturers including GlaxoSmithKline, Merck, Eisai, Johnson & Johnson, Sanofi, Novartis, Bayer and Abbott, committed to eradicate and control a number of neglected and tropical diseases (NTDs).
This brief will examine the declaration, the pledges made and the methods to be used.
ACTA protesters – Do They Have the Wrong Target?
The week of February 6, 2012 saw fresh opposition to the ACTA treaty across Europe, including an online petition which received over 2,000,000 signatures and more than 100 protests in major cities on Saturday, February 11.2 Protesters are calling for the European Parliament to reject the treaty, which they say restricts fundamental rights. Although the European Union and 22 member states have already signed on to ACTA last month, it still needs to be ratified by the European Parliament and implemented by member states.
R&D Tax Credits – Economic Rationale and Impact
The use of R&D tax credits is a growing area of interest for governments and policymakers around the world seeking to stimulate economic activity and innovation. What is the economic rationale behind the R&D tax credit? What do current tax credits look like within the OECD and G20? And do these tax credits stimulate and attract more R&D investment?
Growing the global solar sector – Will investors take a short-term or holistic perspective?
Bloomberg New Energy Finance (BNEF) released figures showing that overall global investment in clean energy reached record highs in 2011, with investment in solar technologies by far the highest. Yet at the same time, 2011 saw a drop in spending on clean energy R&D, and further reductions are expected. Given the increasing dominance of the solar sector, what does this mean for countries, particularly emerging economies, seeking to incorporate solar and other clean energy sources into their energy supplies?
Taking Stock – the Launch of Google Music and the State of Online Copyright Protection
Does the launch of Google Music mark a significant departure in the effort to create a digital platform that can compete with pirated media? Moreover, can it finally bring the music industry back to revenue levels of the early 2000s?
On November 11 Google launched the latest of its initiatives to broaden its brand into new territory. The search-engine behemoth is a major technology player with a vast array of cloud and device-based services ranging from mobile software (Android) to email, office software services, and now music.
On numbers and Access to Medicines – CBO Figures on the PAAG Act are not that Convincing
Will the proposed Preserve Access to Affordable Generics (PAAG) Act actually generate the $4.8 billion savings over 10 years that the Congressional Budget Office suggests it will? How realistic are its assumptions about generic competition or healthcare costs over the next ten years?
The Preserve Access to Affordable Generics Act (S.27), introduced in October 2011, would make illegal patent settlement agreements which pay generic companies a fee to settle drug patent litigation in return for agreeing to withhold marketing their generic drugs until the end, or shortly before, the expiration of the patent under dispute.
Survey of Licensing Activities in Selected Fields of Environmentally Sound Technologies (ESTs)
A Joint Project by the United Nations Environment Programme (UNEP), the European Patent Office (EPO), and the International Centre for Trade and Sustainable Development (ICTSD)
This survey was distributed among leading organizations that are active in the development, patenting, commercialization and transfer of ESTs. More than 160 organizations answered the survey, including companies from the private sector, academic institutions, governmental bodies, national research laboratories, consortiums, etc.