GPs should be looking at the effectiveness of the medicines they prescribe INCLUDING the cost effectiveness since money saved is money available for further care

The first regenerative medicine based on stem cells could be filed for approval in Europe later this year, bringing the groundbreaking medical technology a step closer to reality. In my article, the European Medicines Agency (EMEA) has said that it had been informed about the "intent of a European manufacturer to submit the first application for marketing authorization for a stem cell-based product." For many investors in pharmaceutical companies, stem cells remain off the radar screen for now after early excitement about the science was followed by delays and disappointments in the clinic, but pharmaceutical companies pioneering the technology have not given up and a growing number of large pharmaceutical companies are also starting to dip their toes in the water.

Shouldn't life sciences OEMs be sourcing components from companies like mine so that all the economic benefit stays in the UK?

Has anyone else had experience of negotiating and agreeing a central price for a product or service (e.g. Drug Tariff) only to be then drawn in to attempts at a local PCT level to re-negotiate that price?

I am still concerned by the discourse around the Medical Device Directive, and its possible recast, which may draw it closer to pharmaceutical regulation. Medical devices are significantly different than pharmaceutical products and deserve their own regulations without the added complications of pharmaceutical laws which could hinder innovative development and penalise small businesses. Such a change could also highlight further the current inconsistencies between Notified Bodies which appears to be on the increase.

We contribute directly in the manufacturing chain to the safety of pharmaceutical industry. We are one of the gatekeepers for Quality, and as we are audited to do so (from MHRA) we ensure that the medication is what is supposed to be and is safe. This is a global market and as such, multiple outsourcing is occurring at a high level. This has mainly been dictated by ‘Big Pharma’ and the Generic manufacturers working in niche markets. Pharmaceutical product recalls are very expensive for companies, and the fact that they still happen is amazing. Even politically, the EU is dragging its feet on the way to go for legislation. Globally there are 22,000 API (Active Pharmaceutical Ingredient) manufacturers, and they are not all the same in standards of excellence. The good companies with cGMP (current Good Manufacturing Practice), actively show the quality certificates of the products made. The not so good ones, try to cut corners and save money, and creep into the drug chain. The consumers want cheaper drugs, but quality counts, and this has to be paid for. Currently the role of the ‘QC gatekeeper’ is one that has not been looked at as a key element by some. Just like Health & Safety it is integral to a company, and it only becomes important to everyone, when there is a problem. This is a burning issue to us, as we are the QC Gatekeeper, and as such, we are driving the Quality issues from the bottom up. People and companies are aware, however, cost is always a pressure for some with regards to QC Analysis. The UK leads the way for Quality, historically and currently. This needs to be put across to those that need services like this the most. In the global market our drum is small, but we are banging it harder than ever... so for 2010 onwards we hope to make sweet music

We are routinely coming across pharma companies (small & large) who just don’t keep up with or monitor changes in packaging legislation that will have a major impact on their businesses. A good example is the impending Braille legislation which is now MANDATORY for ALL pharma packs sold in Europe and has to be in place within the next 7 MONTHS. As a consequence of non-compliance, an estimated 20% of pharma companies could have their products delisted. So why do companies ignore it?