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Health and Social Care Bill

BARBARA

2020health blog. 20 January 2011

“...The greatest challenge has in my view always been to win the whole-hearted cooperation of doctors. We have needed to avoid taking too much time away from the frontline care of patients and to ensure that enough doctors turn out to be able, willing and keen to take on the new proposed responsibilities.

With the benefit of hindsight, the greatest mistake has probably been not consulting doctors and their professional bodies more fully prior to publishing the original White Paper. The Government’s proposals are largely based on a belief that doctors and professionals in the NHS know best. At the same time some doctors feel that the Government is not fully respecting their views. This apparent inconsistency damages morale and has implications for working in a spirit of cooperation. A bottom-up decision-making process imposed unilaterally from the top has great potential for teething problems. It is a possible recipe for disaster. The top priority of Andrew Lansley should be to make every effort to get doctors firmly back on side without compromising on the important strategies underlying the proposals...

...More work is needed to determine what tasks doctors are willing and able to carry out and with what assistance. The Government must be seen to be on the same side as NHS professionals. In an undertaking as large and complex as the NHS wise principles and strategies are to no avail without skilled and careful management implementation. If the changes are to be made to a tight timetable, even more attention to detail is vital because there is little time to correct any mistakes.”

DAVID CAMERON

6 April 2011

“...Doctors and nurses are asking what our plans will mean for them.

We hear that – and we want to work with you, not against you.

Now that the Health and Social Care Bill has passed through committee stage in the House of Commons, we’ve got a natural break before this legislation reaches its final stages in Parliament.

We’re taking this time to pause, listen, reflect on and improve our NHS modernisation plans.

Let me be clear: this is a genuine chance to make a difference.

Where there are good suggestions to improve the legislation, those changes will be made.”

Campaigns begun before 2011

Examples of policies put forward by Barbara and subsequent action by others (e.g. Government, opinion leaders) appear below.

No claim is made that she influenced Government policy or opinion leaders or that she was the first person to put any idea forward.

Publication	Nature of Publication	Date /Reference	Policy Proposed by Barbara	Subsequent Action by Others e.g. Government or Opinion Leaders
Health & Household Investors' Brief	Leading UK publication on healthcare in City of London	November & December 1984. Nos. 30, 31 & 32.	Changes to planned Limited List of drugs no longer to be available on the NHS. The Government's original proposals would have led to serious patient suffering.	Following distribution of relevant editions of Health & Household Investors' Brief to all MPs and other lobbying of the Prime Minister (Margaret Thatcher), the Secretary of State for Health (Kenneth Clarke) implemented all Barbara’s proposals.
What Women Want: A Manifesto for Health Click here .	Wide-ranging publication with articles from 17 women. Compliled by 2020health.	March 2010. Barbara’s article, pages 9-12.	1. Higher drug prices and other financial incentives should be awarded to companies with R&D or manufacturing in the UK.	Treasury proposals put forward in November 2010 over a patent box and R&D tax credits. Lansley’s linkage of drug pricing with unmet healthcare needs and innovation , also in November 2010.
			2. Encourage investors to invest in biotechnology companies through tax benefits and grants.	Treasury proposals put forward in November 2010 over patent box and R&D tax credits. Further measures listed in David Cameron's speech of 5th December 2011 .
Comments Re Equityand Excellence: Liberating the NHS Click here .	Submission to Department of Health in response to White Paper. A short summary can be viewed here .	September 2010	1. The main aims in NHS reform should be to provide excellent healthcare, control total costs (net of incoming revenues) and encourage R&D and exports (page 5).	The Conservative Party has a well-established track record of recognising the importance of excellent healthcare, controlling costs and aiming to encourage R&D and exports. Lansley emphasised his commitment to health research on 20 January 2011. The subsequent news over the closure of the Pfizer site in Kent is giving new impetus to the drive to strengthen the environment for R&D . The need to encourage R&D and exports was set out in David Cameron's speech of 5th December 2011.
			2. NHS to make more money from industry e.g. by sharing facilities & more cooperation over clinical trials (pages 11-12).	December 2010 Lansley said that the Academy of Medical Sciences had been asked to recommend ways of simplifying medical research regulation and governance so as to cut the time it takes for the NHS to set up clinical trials. Additional cooperation between the NHS and the industry were announced on 5th December 2011.
			3. No major changes should be made to patent/drug exclusivity or medical approval systems (page 5).	None have been proposed by Government during the process of formulating policy over the NHS.
			4. For the NHS to generate more revenue from the provision of non-medical and add-on services (pages10-11).	The required legal authority is provided under the headings 13R and 14S by sections 19 and 22 of the Bill introduced in late December 2010.
			5. Drug pricing systems that involve agreeing prices of individual drugs before launch should be avoided so as not to delay the availability of valuable new medicines to patients (page 6).	This problem can potentially be overcome by the Government’s proposal put forward in December 2010 to allow launch at a contingent price that will be adjusted later.
			6. NICE’s role in drug rationing should end.	Lansley decided in November 2010 to end NICE’s role in drug rationing. More comment from Barbara here . However, Lansley later partly back-tracked but NICE's terms of reference and powers are being adapted.
NATIONAL HEALTH SERVICE COMMENTS re. Liberating the NHS: Commissioning for Patients. Click here .	Submission to Department of Health in response to White Paper	October 2010	GP consortia should have the services (not necessarily full- time) of a financial expert and a compliance officer, who would check that all rules and procedures were being followed (page 5).	The Bill published in December 2010 requires the appointment (not necessarily full-time) of an "accountable officer", who will essentially cover regulatory aspects of both roles.
Liberating the NHS: Transparency in outcomes- a framework for the NHS Click here .	Submission to Department of Health in response to White Paper	October2010	1. Promising research in industry should be rewarded, whether or not it turns out to be successful (pages 2, 3, & 5).	The Treasury's proposals over R&D tax credits partly meet this objective but much more needs to be done if the UK is to regain its former attractions as one of the best bases for R&D. Richard Sykes has highlighted some of the issues.
			2. Drug prices should be negotiated over a company’s total product portfolio rather than over individual products.	Richard Sykes has highlighted the attractions of the old PPRS drug pricing system. The challenging apects of measuring the value of drugs are recognised even by NICE.
Which Drugs are the Most Innovative? Click here .	Guest blog written by Barbara for 2020health think tank	November 2010	The most support is needed for companies going through a barren period in R&D.	The subsequent cutbacks by Pfizer and others highlight the importance of this point.

Campaigns begun in 2011

Examples of policies put forward by Barbara and subsequent action by others (e.g. Government, opinion leaders) appear below. No claim is made that she influenced Government policy or opinion leaders or that she was the first person to put any idea forward.
Publication		Nature of Publication	Date /Reference	Policy Proposed by Barbara	Subsequent Action by Others e.g. Government or Opinion Leaders
NHS Reforms: Health and Social Care Bill 2011 Click here .		Guest blog written by Barbara for 2020health think tank	January 2011	1. The top priority of Andrew Lansley should be to make every effort to get doctors firmly back on side.	The blog by Barbara was published on 20th January 2011. Eight days later (28th) DAVID CAMERON wrote to doctors.
				2. The wording in the Bill of the statutory duty to pursue equality should be changed.	Proposals to amend the wording were considered in Committee. However, my concern was eventually overcome by extending the duty in respect of research to commissioning consortia.
				3. More than two doctors should be required to run a GP Consortium.	The inclusion of hospital doctors and nurses along with other safeguards covers this point. Click here .
How to encourage pharmaceutical R&D . Click here .		Guest blog written by Barbara for 2020health think tank	February 2011	1. The skills needed for successful drug R&D should be covered more explicitly at university.	The importance of the right focus in developing graduates has been highlighted by Richard Sykes and has been touched upon by the Department for Business, Innovation and Skills .
				2. Government should lobby internationally where the UK alone has insuff	Other countries (e.g. Germany ) are increasingly facing similar problems to the UK. Global innovation for the benefit of mankind could be best achieved by working together.
				3. Cross party support should be encouraged in view of long time-scales in R&D.	Richard Sykes has stressed how the support of successive Governments for the old drug pricing scheme (PPRS) used to benefit the drug industry. Stability is important.
Response to HM Treasury Informal Consultation on the Patent Box. Click here	Submission to HM Treasury in response to consultation document		February 2011	1. To regard profit streams from different uses of a drug separately even if they derive from the same patent.	This proposal is no longer required because of the way in which profits attributable to IP are now proposed to be calculated., as published on 6th December 2011.
				2. Eligibility for the Patent Box should require a high proportion of relevant R&D other than clinical trials to take place in the UK	This anti-avoidance measure is no longer needed because of the changed way in which the benefit from the patent box will be calculated as per the Government's announcement on 6th December 2011.
Response to HM Treasury Informal Consultation on R&D Tax Credits Click here		Submission to HM Treasury in response to consultation document	February 2011	The legi slation and regulations should make clear how they are to be interpreted in different industries.	The Government said in June 2011 that draft guidance will be issued to clarify the meaning of "production" in a number of different situations.
Dept. of Health Consultation on Drug Pricing: “A new value-based approach to the pricing of branded medicines”. Click here .		Guest blog written by Barbara for 2020research think tank	March 2011	1. Satisfying unmet healthcare needs is the goal of commercial, pharmaceutical R&D. Innovation is always a part of R&D but is not an end in itself.	The Department of Health response to the first drug pricing consultation that closed in March has clearly indicated that the Government has recognised the importance of understanding this issue.
				2. More attention needs to be paid to pricing policies over the whole commercial lives of drugs rather than just on launch.	Detailed Government proposals on this point have not yet been made.
				3. The risks involved in implementing the new pricing system could be reduced by keeping more of the positive features of the old system (PPRS)	Richard Sykes has emphasised the benefits of the old system.
Value-based approach to the pricing of branded medicines: a consultation . Click here .	Submission to Department of Health in response to Consultation		March 2011	The Government must recognise that EU law removes a lot of pricing freedom from the UK authorities by permitting parallel imports and exports.	Government does not appear to have fully addressed this issue yet.
The Future of Pharmaceutical R&D Click here .	Guest blog written by Barbara for 2020health think tank		April 2011	Drug companies should be able to raise R&D productivity by improving the management of R&D.	The failure of the R&D model that has been adopted by many large pharmaceutical companies has been widely recognised in recent months. David Cameron highlighted the matter in his speech of 5th December 2011.
The UK Needs More Biotechnology Companies Click here .	Guest blog written by Barbara for 2020health think tank .		May 2011	Scientists should be encouraged to acquire business skills relevant to biotechnology.	The way in which small biotechnology companies in the USA rather than big pharmaceutical giants have often been driving innovation is being increasingly accepted. The importance of small companies was stressed in David Cameron's speech of 5th December 2011.
NHS Reforms – What the UK Government Policy changes Really Mean Click here .	Guest blog written by Barbara for 2020health think tank		June 2011	Competition must not be stifled but should be carefully organised so as to promote the best healthcare at the lowest cost.	Debate on this subject has been intense over the past two months. Unfortunately some commentators seem to have difficulty in being objective because of ideological misconceptions. The thrust of the Government's reforms has remained intact.
The UK Government's Latest Thinking on the Value-Based Pricing of Medicines Click here	Guest blog written by Barbara for 2020health think tank		July 2011	The Government has learned a lot but further careful thought is needed in the light of the UK's limited flexibility in fixing drug prices and the current pressures on the drug industry. Drug pricing anomalies must also be avoided.	The full proposals remain under consideration.

Response to HM Treasury Further Consultation on the Patent Box Click here .	Submission to HM Treasury in response to consultation document		September 2011	1. To allow companies to continue to benefit from the Patent Box even after ceasing to be involved in decision-taking over the relevant patent, providing that the company is actively working on other potentially patentable research.	The recommended change was accepted on 6th December 2011.
				2. The proposals for splitting the profits between patents and other forms of IP should be changed. The value of IP is not closely linked to the cost of creating it	The recommended change was accepted on 6th December 2011.

What should we expect from medical and pharmaceutical R&D in the future?

Click here .

Guest blog written by Barbara for 2020health think tank

September 2011

The choice of research projects is an area that governments should generally leave to professionals and not seek to influence.

My advice has been given recently.

The highest standards of medical care urgently require doctors to remain up to date through Continuing Professional Development.

Click here .

Guest blog written by Barbara for 2020health think tank

October 2011

The General Medical Council should place great emphasis on making sure that doctors remain up to date with new drugs and diagnostic tests.

My advice has been given recently.

Parallel importing and exporting of pharmaceuticals severely limits the options in designing an effective UK drug pricing scheme.

Click here .

Guest blog written by Barbara for 2020health think tank

November 2011

A pure value-based pricing system that excludes the transfer of revenue between products, outlaws patient access schemes and disallows the negotiation of direct arrangements with pharmaceutical companies is not the way forward.

My advice has been given recently.

Campaigns begun in 2012

Publication	Nature of Publication	Date/ Reference	Policy Proposed by Barbara	Subsequent Action by Others e.g. Government or Opinion Leaders
Misleading, Biased Reporting on the Health and Social Care Bill in the Media. Click here.	Guest blog written by Barbara for 2020health think tank	January 2012	Journalists should take special care to ensure that their reporting on the Health and Social Care Bill is fair and accurate.	My advice has been given recently.
The Health and Social Care Bill: Final Stages in Parliament Click here.	Guest blog written by Barbara for 2020health think tank	February 2012	When the Bill becomes law, the NHS will suffer if medical professionals and others fail to co-operate.	My advice has been given recently.
Pharmaceutical R & D – the value of radical innovation versus incremental progress Click here.	Guest blog written by Barbara for 2020health think tank	March 2012	R&D should be directed towards trying to improve the treatment of patients as much as possible irrespective of the degree of innovation involved.	My advice has been given recently.
The NHS needs outstanding management as well as a legal framework, for example, to unlock the potential of the property portfolio. Click here.	Guest blog written by Barbara for 2020health think tank	April 2012	The vast potential of the NHS property portfolio is great enough to justify having some of the very best managers or advisers on the case.	My advice has been given recently.
A wrong decision on UK drug pricing could seriously undermine all the good work that HM Treasury and the Department for Business, Innovation and Skills have done to encourage the UK pharmaceutical industry. Click here.	Guest blog written by Barbara for 2020health think tank	May 2012	The Treasury, the Department for Business, Innovation & Skills and the Department of Health should work closely together. They should be asked to advise ministers on whether value-based drug pricing is an unacceptable risk.	My advice has been given very recently.

THIS PAGE WAS LAST UPDATED ON 21^ST MAY 2012.

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