The Mid Staffordshire NHS Foundation Trust has been placed under administration by Monitor, the NHS economic regulator.

A report for Monitor said the Trust was “unsustainable” and recommended closing down its maternity, A&E and intensive care units.

The first Foundation Trust to go into administration, Mid Staffs will be run for the next 145 days by two analysts from Ernst & Young before it is reconfigured.

The report stated that the services it recommended for closure could be provided at hospitals in North Staffordshire, Wolverhampton and Walsall.

While Monitor said the Francis report was not the reason for its decision, it warned that Mid Staffs was “neither clinically nor financially sustainable”.

Mid Staffs received a £20m bailout in 2012, pending the Francis report’s publication. The report, which listed the Trust’s failures during four years in which over 400 patients died through neglect, did not inspire confidence in its future.

The administrators will seek to work with local commissioners and other healthcare organisations to produce a long-term plan for service delivery. Current services will continue during the 145-day administration period.

A local campaign group, Support Stafford, has called the plans for shutting down acute services in Stafford “unacceptable”.

Jeremy Lefroy, Conservative MP for Stafford, commented: “There is a vital need to retain acute services in Stafford and Cannock because the capacity elsewhere is simply not there.

“They also need to consider the huge disadvantage to local people who would have to travel much longer distances for their treatment, but also for hospital visitors who would have to do the same.”

The payment by results (PbR) system for healthcare reimbursement is unfit for meeting the changing needs of society, according to the King’s Fund.

The think tank identified the current tariff as a barrier to the shift of healthcare from hospitals to the community.

A range of payment systems would be needed, the report argued, to encourage local innovation and to balance the priorities of quality, cost and supply.

The report explored the payment systems used in the NHS and other health economies, and examines whether PbR is able to support such long-term objectives as disease prevention and the care of long-term conditions.

Payment by results incentivises hospitals to continue treatment, thereby blocking a shift to preventative and community-based care, the report said.

It concluded that different services require different payment systems: PbR is most appropriate to elective care, but less suited to other services.

In addition, the King’s Fund said, payment systems need to be flexible to assist adaptation at a local level and trade-offs between priorities.

The NHS needs a new reimbursement framework that allows different payment systems for different types of service, the report argued.

Monitor, the foundation trust regulator, commented that it could “recognise many of the areas for improvement identified in the report” and would give it “careful consideration” when developing its pricing strategy.

Health Minister Lord Howe said: “We are working to make sure a payment system supports care being delivered closer to patients’ homes.”

He added: “We are working to expand our best practice tariff programme which supports patient-focused care, encourages innovation and makes better use of resources.”

The Care Quality Commission has experienced “serious difficulties” in its first 18 months, according to a National Audit Office report.

The NAO said the regulator had “struggled” to fulfil its role due to NHS instability, making only half of the hospital inspections it had planned.

However the CQC was “now taking action to improve its performance”, the report concluded.

The new inspection body replaced the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission in October 2010.

The NAO noted that the abrupt shift had caused “disruption for providers and confusion for the public”.

By April 2011 the CQC had carried out only 53% of its planned inspections of hospitals and care homes, and had not met its schedule for registering care providers.

The organisation suffered from lack of staff, the review said: after a year, 14% of its positions – including 100 inspector posts – were unfilled due to Government restrictions on recruitment.

Its failure to identify patient mistreatment and neglect at a residential care home near Bristol was also criticised.

Both the DH and the CQC itself were to blame for the regulator’s failings, the NAO concluded.

Amyas Morse, head of the NAO, commented: “The CQC has had an uphill struggle to carry out its work effectively and has experienced serious difficulties. It is welcome that it is now taking action to improve its performance.

He added: “The commission and the Department of Health should make clear what successful regulation of this critical sector would look like.”

The DH is currently reviewing the CQC; its findings will be published later this year. Margaret Hodge, Chair of the House of Commons Public Accounts Committee, called the NAO’s report “deeply worrying”.

In the UK joint working is being encouraged to develop innovative services and propagate best practice. But in France, new legislation is placing significant barriers between pharma and its clients. Jérôme Guermonprez explains the implications for market access strategies in the country.

Across Europe pharmaceutical companies have been looking to underpin market access strategies with strong links to healthcare professionals. And while most pharmaceutical companies admit there are significant national differences that demand specific market access strategies, there has been a push, where possible, to leverage expertise, messaging and strategy to drive economies of scale.

Many organisations are now actively embarking upon innovative, cooperative working with regional decision-making bodies – such as the Clinical Commissioning Groups (CCG) in the UK; whilst doctors and pharmacists are increasingly involved in research projects, from clinical research to patient care, patient outcomes and procedures. Indeed, the UK’s amended Health and Social Care Bill strongly encourages pharmaceutical research, innovation and the use of scientific evidence in decision-making.

In France, the forthcoming radical overhaul of the drug regulatory system will significantly change relations between pharmaceutical companies, healthcare professionals, patient associations and physician associations. The “Reforme du Medicament” legislation aims to crack down on health practitioner conflicts of interest, restructure the country’s drug regulator and tighten the process for licensing drugs and for monitoring their effects once in use.

The proposed bill creates compliance requirements that far outstrip the UK anti-bribery laws and includes a number of significant changes which will directly affect the way pharmaceutical companies interact with opinion leaders across the French health service.

To minimise the risk of conflict of interest, the new legislation mirrors the US Sunshine Act by requiring pharmaceutical companies to disclose all financial relationships with healthcare professionals, patient associations and scientific experts.

With an emphasis on patient safety, the bill also requires far more detailed information and discussions about indications – from the provision of a helpline number on every drug packet to enable patients to report problems, to the creation of a government watch list of drugs under review.

It also demands pharmaceutical companies no longer undertake direct physician training but instead provide the funding for training to the government, which will then oversee independent training programmes.

 

Restricted access

Critically, from a market access perspective, the bill will prohibit individual medical representative visits to physicians within a hospital; visits must be collective to avoid any one-to-one relationships and ensure discussions are open and transparent.

The impact of this legislation – which is currently being discussed and should be passed by the French government by the end of 2011 – will be significant for pharmaceutical market access policies and demand companies gain new insight into key opinion leaders (KOL).

Under this new model, the industry will have to be incredibly careful about the type of relationships that are put in place with stakeholders; indeed, at least one pharmaceutical company has already announced it will no longer pay physicians directly in the future or invest directly in physician grants to avoid any regulatory compliance issues.

Furthermore, with many physicians likely to back away from any interaction with the pharmaceutical industry, at least in the short term, patient and physician associations will have a far greater role to play. Pharmaceutical companies will have to rapidly assess the way these associations and individual physicians respond to the new legislation and amend market access strategies accordingly.

 

Regional structure

This new challenge comes at a time when pharmaceutical companies are still adjusting to the major overhaul of the French healthcare system – which has seen the creation of 26 Regional Health Authorities (RHA).

While drug reimbursement is still set nationally as in the UK, since 2009, each region has found the responsibility to adapt national objectives to local or regional health and demographic problematic. Over the past year, each region has had to sign multiple year contracts between the  state and the region to deploy the health strategy.

As in the UK, over the past two years, pharmaceutical companies have realigned resources to create a regional approach based on a key account management (KAM) model. The regional structure has significantly broadened the number of stakeholders involved in decision-making, both financial and medical.

Furthermore, each RHA has a different demographic breakdown and health issues, creating very diverse goals for each region. This change has required a far greater insight into decision-makers and regional objectives; it has also demanded pharmaceutical companies use the KAM approach and strong CRM tools to drive synergies between teams at local, regional and national level.

Pharmaceutical companies in both France and the UK are now actively seeking in-depth insight into the KOLs within new regional structures. Information from the structure of the new organisations, including the multiple drug, technical and price commissions, to identifying specific members, roles and drivers is proving key to create the right regional messaging.

And with this regional, KAM-based model still in its infancy in France, pharmaceutical companies face a tough challenge to ensure the implications of the new medical reform legislation are incorporated.

Messaging, for example, must now be amended to include product safety, as well as quality and efficacy; while companies must ensure information is up to date to ensure changes in physician attitude to the pharmaceutical industry as a result of the new regulations are flagged to remove the chance of inappropriate or unwanted contact. CRM tools will also be essential to coordinate group visits to physicians to avoid any chance of the forbidden one-to-one interaction.

As in the US following the introduction of the Physician Payment Sunshine Act in 2009, pharmaceutical companies will also need help to meet their obligations to declare all activity with physicians.

 

What next?

It is tough to predict how the health service in France will respond to the new legislation over the next 12 months. For pharmaceutical companies there is no doubt that direct physician contact will decline and organisations will have to refocus efforts towards the increasingly influential patient associations and physician associations.

But for those organisations operating across Europe, the changes must demand very different approaches towards health service co-operation. As the UK market looks to drive service innovation and close ties with practitioners at every level, counterparts in France are being compelled to be transparent and improve patient safety. The concept of the global, or even pan–European, market access strategy looks ever less practical.

Jérôme Guermonprez is the Vice President and General Manager, France, Cegedim Relationship Management.