Bayer Healthcare named in advertisements for breaches of the ABPI Code of Practice

16 August 2011

Bayer Healthcare named in advertisements for breaches of the ABPI Code of Practice

Bayer Healthcare has breached Clause 2 of the ABPI Code of Practice and is the subject of advertisements in the medical, pharmaceutical and nursing press.

Bayer Healthcare – Case AUTH/2402/4/11
For using Twitter to announce the launch of two prescription only medicines, Bayer Healthcare was ruled in breach of the following clauses of the Code:
Clause 2 - Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Clause 9.1 - Failing to maintain high standards.
Clause 22.1 - Advertising a prescription only medicine to the public.
Clause 22.2 - Encouraging members of the public to ask their health professional to prescribe a specific prescription only medicine.

The full case report is published in the PMCPA August Code of Practice Review and is also available at www.pmcpa.org.uk.

NICE and the Cancer Drug Fund

The National Institute for Health and Care Excellence (NICE) has unveiled proposed changes to the formula it uses to decide which drugs should be funded by the health service, but the measures have already come in for criticism.

Whilst they aim to take into account a broader, societal view of their value and - in theory at least - should mean fewer rejections of novel therapies, many feel that the removal of the specific “end-of life” criteria could lead to treatments for the elderly and vulnerable being restricted as these groups add least to society in an economic sense.

This fact is highlighted by the Association of the British Pharmaceutical Industry (ABPI), by stating that NICE is not approving enough cancer medications. Indeed analysis by the Office of Health Economics shows that since the introduction of the Cancer Drugs Fund in 2011, the number of cancer drugs that NICE have approved or applied restrictions to their use of, has fallen from 67% to 33%. Yet access to cancer drugs has seemingly increased thanks to policies such as the Cancer Drug Fund. This trend highlights an interesting fact - as NICE no longer has to worry about the political ramifications of approving medications that offer little to no benefit according to their strict criteria, due to the fact that these products will be covered by the Cancer Drug Fund. They rarely approve them, unlike seemingly what they do for medications in other unmet diseases without specific policies behind them designed to enable access. Yet as the future of the Cancer Drug Fund comes under increasing scrutiny due to the increase in expensive orphan drugs that apply to sub sections of cancer patients and the removal of end of life criteria from the NICE formula; it could mean that access to these therapies fall unless strategies taken by pharma and policymakers alike, align. 

Fair play to the UK ABPI for pitching its new Phase I guidance at trial volunteers, instead of just targeting sponsors and investigators. The preface celebrates the fact volunteers used the 2007 version and the update continues with the inclusive tone.

Details such as the above table - which gives a brief but clear summation of the four phases of clinical trials - are a positive move. The guidance also has an extensive glossary and links to other relevant websites. You can download the document here.

Value-Based Pricing Gets De-Valued

The UK’s government’s plan to introduce a new system of drug pricing that aims to take into account the wider value of a new medicine has been criticised by 2020health, a leading healthcare think-tank, as being neither in the national nor patients’ interest.

The coalition government currently plans on switching to value-based pricing (VBP) from 1 January 2014. Under the new system, the wider societal benefit, extended cost savings and the medical value of a drug to different patients are expected to be considered in pricing decisions.

Although details around how VBP will function are unclear, 2020health is concerned that the reforms could have a negative impact on patients. The think tank attempted to approach the subject from a patient’s perspective, and identified a number of risks associated with the reforms, including:

  • Increasing politicisation of pricing decisions
  • A reduced role for patient access schemes
  • Reduced access to innovative new treatments

2020health, along with the Association for the British Pharmaceutical Industry (APBI), would prefer to see an evolution of the current PPRS system. The organization believes that the current system has produced prices below the average in advanced countries, while supporting the R&D environment. Instead of a VBP system, they have called for cost-saving measures, such as revenue caps, increases in the number of patient access schemes, and reduced prices for older drugs.

Pharma continues progress towards clinical trial transparency

Stephen Whitehead, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI) and Dr Ben Goldacre, author of Bad Pharma, have clashed during a debate over progress towards transparency around the publication of clinical trial data.

This debate comes in the week when the UK National Institute for Health and Clinical Excellence (NICE) has signed up to the AllTrials campaign and Roche has promised greater access to trial data.

Text
Photo
Quote
Link
Chat
Audio
Video