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Welcome to the party

Congratulations on the first edition of MedLab News, which is a much needed publication to fill the gap for UK clinical labs since the demise of MLW last year. As director general of BIVDA, I have been asked to provide a short scene setting piece with regards to current issues relevant to the diagnostics industry for this first issue.

You will all be very aware of the recent acquisition and merger of DPC, Bayer and Dade Behring by Siemens - however there is another company, Iverness Medical Innovations (more familiar to people in the UK as Unipath) who have been rapidly buying a diverse portfolio of companies around the world including Biosite, Bio-Stat and most recently British Biocell International. In fact, I believe their strategy is based on the BIVDA membership list! Joking aside, all the mergers and acquisitions are changing the face of the IVD sector.

At the beginning of this year, the BIVDA executive committee looked at a strategy for BIVDA to focus on in 2008 based on industry's needs. Three main areas were clear - procurement, regulatory affairs and maintaining a public affairs campaign to increase awareness of diagnostics with all stakeholders from the Department of Health to the general public.

On the procurement front there is an increasing trend towards managed service contracts for pathology, and varying activity from the regional procurement hubs, Trusts and the addition of NHS Supply Chain into this already complex and confusing picture. BIVDA has concerns about proper application of the rules governing public procurement, not least is the provision of inadequate de-briefs to unsuccessful tenders. New terms and conditions are also a cause for concern, and are being examined and commented on across all the healthcare trade associations.

While many people consider that now the IVD directive has been well established there must be few regulatory issues to resolve, this is far from the case! There are many emerging regulations which affect the sector such as those for waste and packaging, probably the most significant is the REACH directive which may impact on chemicals which can be used in developing and manufacturing tests. For exporters, there are increasing numbers of markets developing local regulations including India, South Africa, the Middle East and Morocco. Some are basing their regulations on the US FDA model, others using the European structure but all have their own individual embellishments which manufacturers need to be aware of. This is where the European Diagnostic Manufacturer Association (EDMA) provides essential support to BIVDA and our member companies.

BIVDA has been maintaining a strong public affairs activity addressing policy which could affect the industry including recent work to engage with DH Commissioning - Gary Belfield will be speaking at the BIVDA Spring Meeting on 22 April 2008. The changes being made to commissioning within primary care may change some aspects of how and where some diagnostic tests are performed - where there is clinical and cost evidence this should drive point of care testing in the community.

These are just a few of the diverse issues on the IVD landscape at the moment - the only certain thing is life is not going to be dull!

BIVDA - the British In Vitro Diagnostics Association - is the national trade association for the IVD industry in the UK. www.bivda.co.uk

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