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Life Sciences: Snippets

Recommendations for increased competition between GP practices

The Competition Authority has published recommendations for changes in the General Medical Services (GMS) system to increase competition between GP practices. It was found that Ireland is facing a GP shortage and people are delaying GP visits due to costs. The GMS system favours existing GP practices and insulates them from competition from newly qualified GPs, which ultimately limits the number of GP practices in Ireland. The recommendations include: (a) access to GMS contracts opening up to all qualified GPs; (b) GPs with a GMS contract being free to move location; (c) decisions to award a GMS contract in a particular area not taking take account of the viability of GPs already practising in the area; (d) the interview system for awarding GMS contracts no longer favouring GPs who already have a GMS contract; (e) payments to GPs under the GMS being decided by the Minister for Health and Children rather than the IMO, following consultation with GPs, and the IMO, if desired.

European Generic Medicines Association pressing for global agreement on biosimilars

The Director General of the European Generic Medicines Association (EGMA) has told a recent Symposium on Biosimilar Medicines that there is a pressing need to reach a global agreement on criteria and guidelines for biosimilar medicines. Many countries, such as USA, Canada and Japan, already have an existing regulatory framework for biosimilars, however it is expected that this market will greatly increase in the coming years with the first major group of originator’s biosimilar products coming off patent.

Nanomaterials under the microscope

The use of nanomaterials in mass-produced consumer products has again been highlighted at EU level. The rotating presidency of the Council of Europe, currently with Belgium, has issued proposals to create a specific register for nanomaterials under the REACH chemicals regulation. Plans are also underway to make it mandatory to identify by way of label the presence of nanomaterials in consumer products. This topic has gained increased prominence recently as the use of nanomaterials in mass-produced consumer products has increased at a much greater pace than the level of scientific knowledge regarding any potential health and environmental risks posed by their use. Separately, it was announced that after completing a first regulatory review of nanomaterials in June 2008, the European Commission is due to complete a second regulatory review of this issue by the end of 2011.

FSAI publishes Guidance Note on Gluten-free and Very Low Gluten Foods

The Food Safety Authority of Ireland has recently published a guidance note on gluten-free foods and avoidance of cross-contamination during manufacture. This guidance note is aimed at those involved in the handling, production and distribution of ‘gluten-free’ or ‘very low gluten’ products and provides advice on the minimum requirements for the production of foods to enable them to carry these terms. This new guidance note follows on from a recent European Commission Regulation setting new standards in relation to the labelling and composition of products claiming to be gluten-free or very low gluten.

FSAI publishes Guidance on Food Additives

The Food Safety Authority of Ireland has recently revised its guidance on the use of food additives. The FSAI aims to clarify a number of issues surrounding this issue including the legislation by which they are regulated. The guidance is available on the Authority’s website at www.fsai.ie.