UK pharma industry set to lose business offshore

March 26, 2008

The pharmaceutical industry has lost confidence in the UK as a place to do business to an “alarming degree” and the situation is only set to deteriorate, reveals new research.

As a result, the country is set to loose out to other locations, according to the research published by the Association of the British Pharmaceutical Industry (ABPI) and the Confederation of British Industry (CBI).

Out of 100 UK-based pharmaceutical companies surveyed, three-quarters had “little confidence” in the current environment, with 83 per cent expecting the situation to worsen and only one per cent believing it will improve.

Almost all the companies surveyed – 97 per cent – said there is now an increasing level of uncertainty within the UK pharmaceutical market environment.

The UK government’s recent decision to abandon the pharmaceutical price regulation scheme (PPRS), which controlled drug prices in the country, has heightened the industry’s uncertainty.

The pharmaceutical industry is a key strategic sector for the UK, being the country’s leading exporter, employing some 70,000 people, and accounting for a quarter of all UK industrial research and development, with £4bn a year being spent.

However, the country now uses fewer innovative medicines than the rest of Europe over the last three years over 10 per cent of jobs (8,000) in this sector have been eroded.

The industry’s propensity towards sending pharmaceutical work to offshore locations that can offer a cheaper and faster turnaround has not helped the situation.

Source: Outsourcing Pharma

About Payment Card Industry (PCI) Compliance Data Security Standards (DSS)

March 26, 2008

It was developed by the major credit card companies as a guideline to help organizations that process card payments prevent credit card fraud, hacking and various other security issues. A company processing card payments must be PCI compliant or they risk losing the ability to process credit card payments.

Today, many employees are paid with payroll cards, a recent innovation that allows employees to access their paychecks from wherever they are.However, sophisticated thieves have been able to extract credit and debit card information from unsecured databases and other means.

This has resulted in a higher incidence of identity theft, a crime that affects merchant companies, financial institutions, e-commerce companies and individuals.Because of these security breaches,the major credit card companies – American Express, Discover, MasterCard and Visa – decided to create regulations to help prevent theft of consumers’ data.

The Payment Card Industry (PCI) Data Security Standards were created by MasterCard and agreed to in 2004 by the four major credit card companies. Each of the credit card companies has its own term for these standards. On June 30, 2005, the regulations took effect.


Medical Device Reporting (MDR)

March 26, 2008

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly.

History of MDR Regulation

Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported. A GAO followup study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.

Source: FDA