In May 2006, the health minister Andy Burnham met Peter Dolan, the chief executive of Bristol-Myers Squibb and chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA), the powerful industry body in the US.
It was the last of 8 meetings with representitives , (Lobbyists), of big pharma, (including pfizer)between sept the previous yr and may 2006…During the period that Owen Smith was working as the head of Policy and Government relations @ Pfizer Global Pharmaceuticals’ UK…
Richard Marsh, director of external affairs at Bristol-Myers Squibb, who also attended the meeting, said that his company had wanted to raise a number of issues with the minister.
( i.e… the deregulation of Pharmaceutical Services and the removal of NICE from it’s involvement in the drug selection process for N.H.S prescribed Pharmaceutical drugs,thus paving the way for the Americal pharma giants such as pfizer to take over under the guise of “patient driven choice”,giving us better access to overpriced drugs with little discernable effect. @ the cost of the British taxpayer…)
Richard Marsh again:
“Companies have a legitimate interest in getting the best for their products and getting a positive appraisal by Nice. Where they have an opportunity to raise issues with ministers, they can do that … It may be that Nice has genuinely got a blind spot about something and a legitimate point can be made to ministers. I don’t think the Nice process is necessarily undermined. It is up to the minister what they do with that information.” He added that companies wanted to invest in countries with a “favourable environment“.
In July 2003, the Government had responded to the Office of Fair Trading (OFT) report
“The Control of Entry Regulations and Retail Pharmacy Services in the UK” which had recommended total deregulation, by setting out a balanced package of reform measures to the national health service regulatory system known as “control of entry”.
The majority of these reforms were introduced by revising NHS regulations in April 2005.
The following is a review of progress in mid-2006 …
STATEMENT TO THE HOUSE:
“My right hon. Friend the Secretary of State announced that review to the House on 13 June 2006.
I am today publishing the Department’s report of that review.
Copies have been placed in the Library.
There are a number of significant findings.
While still early days, the reforms have had a modest impact,
with more than twice as many pharmacies opening in 2005-06 than in any year in the period 1992-93 to 2004-05 and many contractors making use of the new freedoms introduced.
On the evidence so far, the balanced package of reform measures has achieved the goal of opening up the market.
But the impact has been uneven, with pockets of greatest activity across the country. The report finds that deprived areas are neither significantly worse nor better off, though slightly more pharmacies closed in these areas during 2005-06. Primary care trusts (PCTs) with greater social deprivation also attracted proportionately more applications using the new exemptions.
Overall, there is no evidence so far of a detrimental impact on access to pharmaceutical services in deprived areas, nor have the reforms jeopardised the vast majority of the existing pharmacy network or caused widespread upheaval or change.
Nationally, the report found that most people (99 per cent.) can get to a pharmacy by car, walking or public transport within 20 minutes, including in deprived areas. While there is no national evidence yet of a return to pharmacies leapfrogging to secure the most advantageous commercial position, individual PCTs say this is happening locally. There are more pharmacies nearer GP surgeries now compared to 2003.
There is no noticeable impact so far on the prices of over the counter medicines nor on the workforce.
There are some favourable patient experiences reported including better hours, access and quality services.
However, this is not uniform with little change yet seen in rural areas. Patients are concerned about the longer-term impact on accessing services locally.
The NHS has found the regulations difficult to administer and exempt applications in particular hamper their efforts to plan strategically and commission more clinical services.
Innovatory practice is attributed more to the new contractual framework than these reforms.
Business reaction has been mixed. Some reforms have been welcomed, particularly the quicker procedures for administrative decisions, but many were concerned the exemptions to control of entry could lead to long-term reduction in choice and none reported business certainty had improved.
The reforms have had a small but uneven impact on promoting more choice and competition, though access has improved where new 100-hour pharmacies open. This impact is however somewhat erratic and patchy and it is too early to predict whether these improvements will be long-lasting.
While the new legislative regime has delivered benefits in terms of quicker processes for some types of application, this is tempered by the regime being complex, time-consuming and offering no greater certainty and reliability to business.
We will continue to monitor the progress made by these reforms through NHS and central statistical returns and there are a number of adjustments we wish to make to the regulations to improve the operational effectiveness of the current regime.
We will come forward with further proposals in due course. These will include the remaining reforms which required primary legislation (charging for applications and new factors which PCTs will take into account when deciding competing applications) and which are now enacted in the Health Act 2006.
We intend to make further announcements about the regulatory changes needed to introduce these shortly.
When considering the outcome of this report, it is important also to consider the achievements against the most recent priorities we set out in the White Paper “Our Health, Our Care, Our Say” which the Secretary of State launched last year.
While this report shows that the approach we took back in 2003 was the right way to proceed we consider it is open to further debate whether the control of entry system remains a suitable vehicle to enable primary care trusts to meet their new roles and responsibilities for commissioning a patient-led NHS.
There remain considerable shortcomings in the current system.
The market remains largely provider-led.
Primary care trusts have insufficient influence to commission or exercise sufficient control over where services are provided to meet greatest needs.
There remain particular concerns about securing adequate access to services in rural areas. All these factors create additional financial pressures on the NHS and prevent best value for money being secured.
Such shortcomings are not consonant with the principles for reform of the public sector and our White Paper ambitions for creating a patient-led NHS.
On this basis, we have decided that it would not be prudent to propose further major changes to the current system, either in terms of moving towards greater deregulation or imposing tighter restrictions.
Instead, we have concluded the time is right to consider how we can best shift the focus away from a system which is largely a legacy of the last century to more modern and reformed contractual arrangements which can better meet the health needs and challenges of this century.
In short, instead of “control of entry” being the dominant market force and determinant of service provision, we shall review what action is needed to allow primary care trusts to have more powers to commission as is necessary to secure adequate service provision to meet local health needs, while ensuring the opportunities to maximise choice and contestability within a reformed system are not lost.
I am therefore pleased to announce today that the Department is initiating a series of discussions with interested stakeholders to review these contractual arrangements. I have invited Anne Galbraith, a lawyer and former chair of the Prescription Pricing Authority, to lead and chair these discussions and am delighted she has accepted.
Anne also chaired the previous advisory group in 2003 which examined how best we could introduce the control of entry reforms. Anne will be inviting representatives from patient and consumer groups, the NHS and professional, representative and trade associations to put forward their views.
We have asked Anne to report to the Department by March 2007 and the results of her discussions will then inform the next steps, including formal consultation in the spring, the Department needs to take.”
This work will help fulfil our commitment in “Our Health, Our Care, Our Say” to review contractual arrangements in line with the White Paper’s ambitions.
I very much look forward to the results of Anne’s work. I am confident this will prove an important driver for ensuring we bring pharmaceutical services into the mainstream of NHS services, provide a firm basis on which the NHS can invest to secure the improvements in health and well-being we all want to see and give business the confidence it needs to sustain its commitment to the NHS, patients and consumers alike.
Today – 11 January 2007 – the Minister of State, Department of Health (Andy Burnham) made a written ministerial statement to Parliament on the Department of Health’s review of the pharmacy control of entry regulatory system.
The key points he made were Not exactly what the big pharma had wanted…
He recognized that the exemptions to control of entry could lead to long term reduction in choice and that business uncertainty had not improved.
He commented that the current control of entry system is not a suitable vehicle to enable PCTs to meet their responsibilities to carry out strategic planning and commissioning.
He decided that it would not be prudent to propose further major changes to the current system, either in terms of moving towards greater deregulation or imposing tighter restrictions.
This is what The Pharmaceutical Journal ,15 SEP 2006, had to say…
PSNC opposes further easing of contract controls.
“This review is being conducted soon after the reforms were brought into force, yet the evidence is that applicants have seized on the opportunities afforded by the exemptions, and the new criteria of choice, and that this has opened up the pharmacy market to a very great extent.”
Overall, there have been 130 new contracts granted in the first year of the control-of-entry reforms, of which more than 100 were for 100-hour pharmacies and pharmacies in large retail developments.
However, the PSNC adds that a mechanism for existing contractors to appeal against new contracts granted under the exemptions should be brought in.
This is because NHS Litigation Authority figures, based on cases where appeals are possible, show that primary care trusts are more likely to award contracts that should be refused than they are to refuse applications that should be approved.
“If this proportion occurred in the case of exempt applications where appeals are not possible then there will be considerable injustice,” the PSNC says.
The PSNC also believes that PCTs are likely to be unable to monitor whether new contractors comply with any commitments they make in order to win their contracts.
diggaman.net , submitted by Psico.
NHS Pharmaceutical Services in England 2006
(Control of Entry)…written ministerial statement.
Note: Review of progress on reforms in England to the Control of Entry system for NHS pharmaceutical contractors – PSNC Response (2006) (134 KB) this file,on the Pharmaceutical Services Negotiating Committee web site returns a 404 file not found, and so could not be accessed , the new site at http://psnc.org.uk no longer keeps the files on archive….