Innovation in the pharmaceutical industry:a study of the effects of regulation on the U.K. pharmaceutical industry

A history of government drug regulation and the relationship between the pharmaceutical companies in the U.K. and the licensing authority is outlined. Phases of regulatory stringency are identified with the formation of the Committees on Safety of Drugs and Medicines viewed as watersheds. A study of the impact of government regulation on industrial R&D activities focuses on the effects on the rate and direction of new product innovation. A literature review examines the decline in new chemical entity innovation. Regulations are cited as a major but not singular cause of the decline. Previous research attempting to determine the causes of such a decline on an empirical basis is given and the methodological problems associated with such research are identified. The U.K. owned sector of the British pharmaceutical industry is selected for a study employing a bottom-up approach allowing disaggregation of data. A historical background to the industry is provided, with each company analysed or a case study basis. Variations between companies regarding the policies adopted for R&D are emphasised. The process of drug innovation is described in order to determine possible indicators of the rate and direction of inventive and innovative activity. All possible indicators are considered and their suitability assessed. R&D expenditure data for the period 1960-1983 is subsequently presented as an input indicator. Intermediate output indicators are treated in a similar way and patent data are identified as a readily-available and useful source. The advantages and disadvantages of using such data are considered. Using interview material, patenting policies for most of the U.K. companies are described providing a background for a patent-based study. Sources of patent data are examined with an emphasis on computerised systems. A number of searches using a variety of sources are presented. Patent family size is examined as a possible indicator of an invention's relative importance. The patenting activity of the companies over the period 1960-1983 is given and the variation between companies is noted. The relationship between patent data and other indicators used is analysed using statistical methods resulting in an apparent lack of correlation. An alternative approach taking into account variations in company policy and phases in research activity indicates a stronger relationship between patenting activity, R&D Expenditure and NCE output over the period. The relationship is not apparent at an aggregated company level. Some evidence is presented for a relationship between phases of regulatory stringency, inventive and innovative activity but the importance of other factors is emphasised.

The role and relevance of non-government aid:a case study of Kenya

How effective are non-government organisations (NG0s) in their response to Third World poverty? That is the question which this thesis examines. The thesis begins with an overview of the problems facing Third World communities, and notes the way in which people in Britain have responded through NG0s. A second part of the thesis sets out the issues on which the analysis of NGOs has been made. These are: - the ways in which NGOs analyse the process of development; - the use of 'improving nutrition' and 'promoting self-reliance' as special objectives by NG0s; and - the nature of rural change, and the implications for NGOs as agents of rural development. Kenya is taken as a case study. Firstly the political and economic structure of the country is studied, and the natures of development, nutritional problems and self-reliance in the Kenyan context are noted. The study then focusses attention onto Kitui District, an area of Kenya which at the time of the study was suffering from drought. However, it is argued that the problems of Kitui District and the constraints to change there are as much a consequence of Kenya's structural underdevelopment as of reduced rainfall. Against this background the programmes of some British NGOs in the country are examined, and it is concluded that much of their work has little relevance to the principal problems which have been identified. A final part of the thesis takes a wider look at the policies and practices of NG0s. Issues such as the choice of countries in which NGOs work, how they are represented overseas, and their educational role in Britain are considered. It is concluded that while all NGOs have a concern for the conditions in which the poorest communities of the Third World live, many NGOs take a quite narrow view of development problems, giving only little recognition to the international and intranational political and economic systems which contribute to Third World poverty.

The UK obesity epidemic:new steering instruments for a new public policy problematic?

Since the 1980s UK government enthusiasm for market reforms has reconfigured the nature and scope of public services. Initially the marketisation of public services changed how public services were provided, increasingly market reforms and pro business policies have also modified the formation and understanding of public policy problematics and how they ought to be resolved. This is particularly noticeable when markets work imperfectly or even fail. UK governments have shown their reluctance to employ regulatory instruments to change the behaviour of companies preferring instead to make use of softer interventions, by focusing on providing advice for consumers and urging individuals to act responsibly. The dilemmas of this approach are explored by discussing the UK's former Labour government's (1997–2010) response to the increase in the incidence of obesity and related health complications.

Enterprise and Regulatory Reform Act 2013

This factsheet was last updated in August 2013. Background to the Act The Enterprise and Regulatory Reform Bill was introduced to Parliament in May 2012 and, following various amendments, received Royal Assent on 25 April 2013. In early June 2013, the Government issued an indicative timetable of commencement dates for the various sections of the Act. While some of the changes have come into force or had definite implementation dates announced, for other there is no definite date. The Act is broad ranging. Although this factsheet focuses specifically on employment related issues it is important to note that the Act also makes other provisions: Login or register for a free account to continue reading this factsheet and to learn about: •Background to the Act •Employment provisions of the Act •Action points for employers •CIPD viewpoint •Useful contacts •References •Further reading

Changing policies for the automotive industry in an 'old' industrial region:an open innovation model for the UK West Midlands?

Automobile manufacture in the UK West Midlands peaked during the 1950s and early 1960s but, with overseas competition, declined thereafter. Successive policies, such as government supported mergers to form the British Motor Corporation in the 1950s, green-field development away from the region in the 1960s, nationalisation of the (then) British Leyland in the 1970s, Japanese FDI in the 1980s and the Rover-centric Accelerate Project in the 1990s have failed to halt the decline. Since early 2000, regional policy has been the responsibility of the Regional Development Agency, Advantage West Midlands. The RDA has moved away from traditional support based on the needs of big companies or ‘champions’ and adopted an approach centred on a mix of small and large businesses and high level research, and – arguably – an ‘open innovation’ model. Here, we examine these new policies and their potential to create an innovative and competitive regional environment.

Resource enclavity and corporate social responsibility in Sub-Saharan Africa:the case of oil production in Ghana

Why has Corporate Social Responsibility (CSR) yielded such disappointing outcomes in oil-rich sub-Saharan Africa? Over the past decades, a sizable body of literature has emerged which draws attention to the shortcomings of oil-related development and complementary CSR exercises in the region. Most critiques on the topic, however, assess specific interventions and/or policies but fail to evaluate the complex decision-making processes, dictated heavily by setting, which produce such actions altogether. This thesis attributes CSR outcomes in oil-rich sub-Saharan Africa to the unique context in which the decisions underpinning actions take place. In doing so, the analysis borrows ideas from a diverse body of literature spanning the international development, accounting, management and political science disciplines. To explore these ideas further, the thesis focuses on the case of Ghana. The most recent “addition” to sub-Saharan Africa’s oil club, Ghana provides a rare glimpse of how decisions underpinning CSR have been identified, evolved and reshaped from the outset. To provide a comprehensive picture of CSR in the sector and its impacts at the local level, interviews and focus groups were conducted with a range of stakeholder groups. As is the case throughout sub-Saharan Africa, in Ghana, oil production occurs in offshore “enclaves”, which are disconnected geographically from local communities. This thesis argues that these dynamics have important implications for CSR. Findings point to companies also being disconnected ideologically from local development needs, which, in part explains the questionable CSR that has become such a contentious issue in the debate on oil and development in sub-Saharan Africa in recent years. The enclave-type setting in which oil production occurs appears to have stifled creativity and innovation in the area of CSR. This, along with institutional weaknesses, regulatory deficiencies and the Government of Ghana’s failure to adequately respond to local-level concerns, has produced these outcomes.

From bilateral to trilateral governance in local government contracting in France

In France, the tradition of contracting out local public services has been predominantly one of partnership and co-operation rather than competition and antagonism. However, in recent years the traditional approach has come under intense criticism, something which has far-reaching implications for public-private governance. Adopting the socio-legal approach to the study of contract governance set out by Peter Vincent-Jones, this paper explores the discrepancy between descriptions of a traditional French approach to local public services governance, in which the bilateral values of trust and co-operation are emphasized, and a new discourse of local public services governance, which argues for detailed contract planning and close contract monitoring. It is argued that this discrepancy reveals the beginning of a shift in the governance of public service exchange relationships from relatively noncontractual and bilateral to relatively contractual and trilateral. The French case highlights the importance of regulatory and accountability frameworks to the manner in which contracting parties perceive exchange governance. © Blackwell Publishing Ltd. 2005.

Application of Classification Methods to a Problem Related to Specific Groups of E-Government Users

This paper was partly supported by ELOST – a SSA EU project – No 27287.

Public R&D policies and private R&D investment:a survey of the empirical evidence

The importance of R&D investment in explaining economic growth is well documented in the literature. Policies by modern governments increasingly recognise the benefits of supporting R&D investment. Government funding has, however, become an increasingly scarce resource in times of financial crisis and economic austerity. Hence, it is important that available funds are used and targeted effectively. This paper offers the first systematic review and critical discussion of what the R&D literature has to say currently about the effectiveness of major public R&D policies in increasing private R&D investment. Public policies are considered within three categories, R&D tax credits and direct subsidies, support of the university research system and the formation of high-skilled human capital, and support of formal R&D cooperations across a variety of institutions. Crucially, the large body of more recent literature observes a shift away from the earlier findings that public subsidies often crowd-out private R&D to finding that subsidies typically stimulate private R&D. Tax credits are also much more unanimously than previously found to have positive effects. University research, high-skilled human capital, and R&D cooperation also typically increase private R&D. Recent work indicates that accounting for non-linearities is one area of research that may refine existing results. © 2014 John Wiley & Sons Ltd.

"Trade creep" and implications of the Transatlantic Trade and Investment Partnership Agreement for the United Kingdom National Health Service

The ambitious and comprehensive Transatlantic Trade and Investment Partnership Agreement (TTIP/TAFTA) agreement between the European Union and United States is now being negotiated and may have far-reaching consequences for health services. The agreement extends to government procurement, investment, and further regulatory cooperation. In this article, we focus on the United Kingdom National Health Service and how these negotiations can limit policy space to change policies and to regulate in relation to health services, pharmaceuticals, medical devices, and health industries. The negotiation of TTIP/TAFTA has the potential to "harmonize" more corporate-friendly regulation, resulting in higher costs and loss of policy space, an example of "trade creep" that potentially compromises health equity, public health, and safety concerns across the Atlantic.

Representation and misrepresentation of scientific evidence in contemporary tobacco regulation:a review of tobacco industry submissions to the UK Government consultation on standardised packaging

BACKGROUND: Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for 'more evidence', but four months later a second 'independent review' was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP. METHODS AND FINDINGS: We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, 'mimicked scientific critique' was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in 'evidential landscaping', promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach. CONCLUSIONS: The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.

The Future of EU Cohesion Policy. Endogenous Development – Added Value of Intervention – Regulatory Frameworks

The successful operation of the regional development – or cohesion – policy of the European Union has a strategic importance from the point of view of the whole integration process. Strengthening economic, social and territorial cohesion and decreasing disparities between member states and regions are not only one of the main priorities of the integration, but at the same time these are justified expectations of the people living in the member states of the union. The cohesion transfers should be spent on those factors which have the biggest contribution to the improvement of development prospects and competitiveness in the given regions. Theories on regional development have controversial conclusions about the long-term formation of development disparities. However, it has become evident that successful development policies are based on endogenous factors, innovation and well-functioning institutions. After examining theoretical considerations and regional disparities the study analyses the impacts of EU regional policy and evaluates the main elements of the proposed regulatory frameworks for the period 2014-2020.

Az állam szerepe a turizmusban (The role of government in tourism)

Az állam szerepe napjainkban átalakulóban van, ami az egyes gazdasági területeken más és más szabályozórendszer alkalmazását igényli a szakterület sajátosságainak és az iparág igényeinek, nemzetközi környezetének megfelelően. A turizmus azon gazdasági területek közé tartozik, amelynek szerepe az elmúlt időszakban dinamikusan növekedett, többek között jelentős bruttó hazai termék-előállító, munkaigényes jellegéből, valamint jelentős beruházást gerjesztő hatásából adódóan. A turizmus mint üzleti tevékenység nem nélkülözheti az állam szerepét. Számos olyan externália társul hozzá, ami államilag koordinált esetben a fejlődést magasabb pályára állítja, és társadalmilag hatékonyabb szinten valósul meg. Napjainkban az állam szerepének újraértelmezése, feladatainak újbóli átgondolása és a megfelelő súlypontok megtalálása elengedhetetlenül szükséges annak érdekében, hogy a turizmus pozitív hatásai hosszú távon érvényesüljenek. _______________ Nowadays the role of the government is changing, which needs the usage of different regulatory systems regarding the requirements of the industry and the international environment. Tourism belongs to the economics fields which importance are growing very rapidly because of its effects such as GDP contribution effect, workforce effect and investment exciting effect. Tourism as a business activity needs the significant role of the government. Tourism is in association with a lot of externalise, therefore can secure the coordination of the state the development and the efficiency at a higher level. Nowadays the rethinking of the task of the government is needed on the field of tourism in the interest of the enforcement of its positive effects.

The effects of government disability benefits, accessibility laws and rehabilitation on employment choices by individuals with spinal cord injuries

Greater inclusion of individuals with disabilities into mainstream society is an important goal for society. One of the best ways to include individuals is to actively promote and encourage their participation in the labor force. Of all disabilities, it is feasible to assume that individual with spinal cord injuries can be among the most easily mainstreamed into the labor force. However, less that fifty percent of individuals with spinal cord injuries work. ^ This study focuses on how disability benefit programs, such as Social Security Disability Insurance, and Worker's Compensation, the Americans with Disabilities Act and rehabilitation programs affect employment decisions. The questions were modeled using utility theory with an augmented expenditure function and indifference theory. Statically, Probit, Logit, predicted probability, and linear regressions were used to analyze these questions. Statistical analysis was done on the probability of working, ever attempting to work after injury, and on the number of years after injury that work was first attempted and the number of hours worked per week. The data utilized were from the National Spinal Cord Injury Database and the Spinal Cord Injuries and Labor Database. The Spinal Cord Injuries and Labor Database was created specifically for this study by the author. Receiving disability benefits decreased the probability of working, of ever attempting to work, increased the number of years after injury before the first work attempt was made, and decreased the number of hours worked per week for those individuals working. These results were all statistically significant. The Americans with Disabilities Act decrease the number of years before an individual made a work attempt. The decrease is statistically significant. The amount of rehabilitation had a significant positive effect for male individuals with low paraplegia, and significant negative effect for individuals with high tetraplegia. For women, there were significant negative effects for high tetraplegia and high paraplegia. ^ This study finds that the financial disincentives of receiving benefits are the major determinants of whether an individual with a spinal cord injury returns to the labor force. Policies are recommended that would decrease the disincentive. ^

Community Development Districts: The entrepreneurial side of government

In an effort to reduce the cost and size of government public service delivery has become more decentralized, flexible and responsive. Public entrepreneurship entailed, among other things, the establishment of special-purpose governments to finance public services and carry out development projects. Community Development Districts (CDDs) are a type of special-purpose governments whose purpose is to manage and finance infrastructure improvements in the State of Florida. They have important implications for the way both growth management and service delivery occur in the United States. This study examined the role of CDDs for growth management policy and service delivery by analyzing the CDD profile and activity, the contribution of CDDs to the growth management and infrastructure development as well as the way CDD perceived pluses and minuses impact service delivery. The study used a mixed methods research approach, drawing on secondary data pertaining to CDD features and activity, semi-structured interviews with CDD representatives and public officials as well as on a survey of public officials within the counties and cities that have established CDDs. Findings indicated that the CDD institutional model is both a policy and a service delivery tool for infrastructure provision that can be adopted by states across the United States. Results showed that CDDs inhibit rather than foster growth management through their location choices, type and pattern of development. CDDs contributed to the infrastructure development in Florida by providing basic infrastructure services for the development they supported and by building and dedicating facilities to general-purpose governments. Districts were found to be both funding mechanisms and management tools for infrastructure services. The study also pointed to the fact that specialized governance is more responsive and more flexible but less effective than general-purpose governance when delivering services. CDDs were perceived as being favorable for developers and residents and not as favorable for general-purpose governments. Overall results indicated that the CDD is a flexible institutional mechanism for infrastructure delivery which has both advantages and disadvantages. Decision-makers should balance districts’ institutional flexibility with their unintended consequences for growth management when considering urban public policies.