Pharmaceuticals Policy and Law

The pharmaceutical sector in the European Union is innovative, but not innovative enough to compete on the world market. This article addresses this issue from the perspective of market harmonization, since the European Commission perceives – according to the ‘European 2020 Flagship Initiative – Innovation Union’ – market fragmentation to be one of the major causes of the lack of innovation. In order to establish if maximum harmonization benefits innovation, two distinct legal regimes in the pharmaceutical sector will be compared. The general rules for medicinal products are weighed against the orphan medicinal products scheme. The latter is subject to uniform Union rules specifically introduced to stimulate research and development and has led to the development of a number of new products.

The article shows that the most radical positive integration depends to a large extent on the prospect of it yielding revenue for the innovator. Hence, fuller harmonization can benefit innovation, but it is just as important, if not more important, to address other factors such as pricing, reimbursement and patent protection.

Regulation (EC) No 2141/96 holds no explicit provision about the validity of a EU centralised marketing authorisation for a medicinal product during the time gap between dissolution of the transferor after granting of a favourable opinion by the EMA and effective authorisation by the European Commission. Marketing authorisations for medicinal products in terms of Article 3(1) of Regulation (EC) No 726/2004 are personal administrative acts, which, in principle, excludes a transfer unless otherwise and under exceptional terms allowed (enumeratio ergo limitatio). Regulation (EC) No 2141/96 constitutes such an exemption, laying down the procedural rules for a transfer of marketing authorisation. Though for this particular case the regulation holds no explicit provision about validity during the time gap. Despite the absence of a provision about validity the time gap has to be filled by teleological interpretation to ensure that amongst several possible interpretations the one will prevail which best guarantees the practical effect of existing Community law. The examination of the objectives of the Regulations (EC) No 726/2004 and No 2141/96 indicate the validity of the marketing authorisation and consequently the transferee's authorisation during that period of time.

In Britain there is widespread concern that the CJD virus could strike again. This is because research points to its long incubation period. The original ‘Mad’ cow disease, or bovine spongiform encephalopathy (BSE), initially emerged in Britain in 1986 as a result of animal feed when beef offal was fed to cattle, which are natural grass-grazers. There were reports that there were an estimated 2 million children who were prescribed BSE risk medicines by the department of health and some drug companies responded to the outbreak by quickly switching to non-UK sources for bovine material for their vaccines. The key issue is how long stocks of these medicines continued to be used until they were all exhausted. There was apparently no with drawl by the drugs makers and they were only required to terminate their manufacture in March 1989. The impact was a long duration in eradicating the UK-sourced material from the manufacturing process that the government admitted. There needs to be a greater application of the epidemiological studies of prion transmission, that would reduce the infectivity of human tissues, and the efficacy of removing microbes by de toxificating their manufacture.

Health spending accounted for 9.3% of GDP on average across OECD countries in 2011. The Pharmaceutical expenditure, as a percentage of total expenditure on health, accounted for 15%. The pharmaceutical sector is highly regulated. On describe the major characteristics of the world pharmaceutical industry as one increased globalization, changing structure of competition and increased competitiveness. This are growing pressures on discovery and development. Drug liabilities become more frequent and more costly. The pharmaceutical industry is under immense pressure by external and internal stakeholders. Government and National Health Services are monopsonic practices. Pharmaceutical companies are criticised for high prices, over-intensive sales and marketing activities, presents to medical doctors, clinical trials and industry – government alliances. Lawyers, medical journals, physicians, politicians, and the media use product liabilities and marketing activities to denounce pharmaceutical companies as culprits. The pharmaceutical sector needs to demonstrate responsibility and take steps to increase awareness. Transparency would increase the credibility of the pharmaceutical industry. Corporate governance will prevent corruption by being in compliance with the legislation and establishing their own internal policies designed to prevent corruption. All firms will act more responsibly. In order to rebuild the trust the industry needs to work together and quickly.

A major revision of the pharmacovigilance legislation came into force in the European Union (EU) in 2010 and applies from July 2012. A technical implementing regulation and detailed guidance have been issued in 2012 to facilitate this enhancement of EudraVigilance. Major emphasis has been put on further strengthening the role of EudraVigilance as regards simplifying adverse reaction reporting, collecting adverse reactions, detecting new risks, monitoring known or potential risks and providing stakeholders with adequate access to adverse reaction data.

The legislation has created the Pharmacovigilance Risk Assessment Committee that is responsible for assessing all aspects of the risk management of medicines for human use. The Risk management system are a set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products. The requirements in the Directive and Regulation include provisions for post-authorisation efficacy studies, in addition to post-authorisation safety studies.