EDITOR’S PAGE
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Applications of PEGs in drug
egislative and regulatory concerns seem to be the issue of the day at least for two of the major industry trade associations. As highlighted in the news pages of this issue, US chemical industry association SOCMA is concerned over the progress of the Toxic Substances Control Act and is particularly concerned about the impact of partisan politics on how the legislation will develop and be implemented. To quote Bill Almond, SOCMA’s Vice President of Government and Public Relations, until the Democratic amendment to the TSCA was approved by the US Senate, “progress was being made by both sides toward a workable approach, only to snatch defeat from the jaws of victory.” However, SOCMA did say that the amendment was an improvement over the previous version of the legislation, but the Association remains very concerned that a partisan approach in Congress to its implementation could jeopardise and, indeed, possibly reverse the good progress made to date in this area.
Back in the EU
Meanwhile, back in Europe, the UK’s BioIndustry Association has welcomed proposals for an EU Regulation on clinical
trials. The Association said “a simplified and efficient regulatory framework for clinical trials is vital to improve Europe’s attractiveness as a global location for clinical research and development of new medicines.” The Association said such a Regulation would benefit all stakeholders in the EU, allowing patients faster access to treatments whilst reducing the administrative burden and costs for public and private sector researchers, as well as for EU Member States.
Early access to medicines scheme Another example of the BIA’s ‘satisfaction’ with the legislative and regulatory environment of late is the Association’s welcome for the consultation proposals of the UK’s Medicines and Healthcare products Regulatory Agency on an Early Access to Medicines Scheme as part of the British Government’s Strategy for UK Life Sciences. The BIA’s new CEO, Steve Bates, said such a scheme would facilitate the availability of promising medicines to patients at an earlier stage in their development cycle. However, the BIA did express concern over the proposal being limited to only one or two medicines a year, targeted at the end of Phase 3 trials. In the BIA’s view, this “does
Tom Mulligan
not meet the ambition the UK Government set out in its Strategy for UK Life Sciences.” So, some dissatisfaction with politicians there too.
Keep up the pressure I think the examples quoted above demonstrate very clearly the need for trade associations to keep up the pressure on politicians to legislate sensibly in the highly technical and life-impacting areas that are the pharmaceutical and biotechnology sectors. No clearer example can be found of the need to minimise the influence of partisan politics than in the TSCA debate in the USA. Similarly, in Europe, in spite of the good prospects for progress in the health legislation field, trade associations need to remind the authorities of what new legislation should be intended to achieve. It will be interesting to see what developments there will be in the near future in these important regulatory areas, in both the USA and Europe.
Tom Mulligan, MSc Editor - sp2 Inter-Active
4 sp2 Inter-Active July/August 2012
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