Changes to the UK drug industry code of practice (ABPI) will require drug companies to make an annual declaration of how much money they have paid to doctors for use of their services. The changes will see each drug company declare the amount and the number of times payments were made to doctors, including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings. The code does not however require individual doctors to be named.Another change to he code which comes into effect on 1st Jan 2011, will ban the industry from providing branded promotional items such as pens to healthcare professionals. Health professionals may still get pens and paper at conferences but this will not bear the name of any medicine, just the company name.BMJ 2010, 341, c6290
An Australian subsidiary of Roche has been fined £124,200 for offering a regional public health organisation funding for a nursing position in exchange for doctors in the region prescribing its hepatitis drug Pegasys.
BMJ 2010, 341, c6232
GSK is to pay $750m to settle cirimal and civil complaints that the company had for year knowingly sold adulterated formulations of four drugs it produced in Puerto Rico.
Andrew Lansley, health secretary, has repearted stated his intention of moving the NHS to a value based pricing for drugs in the NHS. This means the government will negotiate prices with the pharmaceutical companies according to the therapeutic benefits they will bring to patients. However, this means that the role of NICE in ruling whether drugs should be made available to patients on the NHS will be reductant. In addition, this move will lead to GPs having to take on the role of rationing drugs and is likely to lead to a postcode lottery.
BMJ 2010, 341, c6240
The drug companies pay hundreds of doctors who have been disciplined for ethical breaches or had their medical licences revolked as speakers and consultants says a ProPublica report. The reporters created a searchable database of payments to doctors since 2009. The report can be found at http://www.propublica.org/article/profiles-of-the-top-earners-in-dollar-for-docs and the database at http://projects.propublica.org/docdollars/.
BMJ 2010; 341:c6026
The EMA has launched much stricter rules for its experts’ interactions with the drug industry. The agency’s new guidance on conflicts of interest says people who have interests in a company will have their work with the agency restricted. The policy is due to come into efect next year.
BMJ 2010, 341, c5902
The coalition governement has dropped plans to introduce the automatic substitution of generic drugs in primary care in England.
BMJ 2010, 341, c5780
Executives of drug companies could face criminal charges if companies promote the off-label use of drugs, says an attorney for the US Food and Drug Administration. This aims to move away from fines to companies which does not currently seem to act as a deterrent for companies.
BMJ 2010, 341, c5808
Tesco has been granted permission to sell sildenafil (Viagra) in 300 pharmacies in its supermarkets without the need for a prescription from a GP. The Medicines and Healthcare Regulatory Agency confirmed that sildenafil remains prescription only and that Tesco has been granted permission to dispense the drug uder a special licence called patient group direction. These licences are granted in situations where they offer an advantage to the care of patients without compromising their safety and where they provide an opportunity for general health screening.
BMJ 2010, 341, c5294
On September 22, the European parliament agreed new legislation on pharmacovigilence. Under this new system, national web portals will be established to provide the public with information on medicinal products and any known side effects. The portals will contain assessment reports, summaries of product characteristics and information leaflets. They will be linked to the EU’s EudraVigilance database.
BMJ 2010, 341, c5344