The Government needs to do more to support life sciences in the UK and create an environment where the industry can flourish, a new survey has found.

RSA’s The UK Life Sciences Leaders’ Survey 2011 revealed worries over the NHS reforms, medicine pricing and reimbursement, employment issues and the cost of research amongst its leaders.

Nick Stephens, CEO of RSA, says the Government “urgently needs to do more to ensure that education, regulation, access to medicines and the NHS research base align to support the industry’s continued contribution to the UK economy”.

The report is the second annual survey of industry bosses. Last year the general feeling was of optimism with leaders believing the recently elected coalition Government would improve the business environment.

But twelve months later the mood has changed with results finding leaders claim the UK is not competing effectively globally, creating opportunities for early phase/smaller companies or making the most of its unique selling points: the NHS and skills in innovation and discovery.

Leaders also raised concerns about the increasing cost of working in the UK, the implication of R&D as a result of the NHS reforms, the regulatory burden on operations and the process from development to market. They also advised that fiscal and tax incentives should be given to SMEs to help their growth and the UK compete globally.

Worries were also raised about the introduction of value-based pricing. However, in contrast, health technology assessments were broadly welcomed as a means of enhancing value and meeting therapeutic requirements, the report found.

During the tough economic environment, the survey found that leaders would focus on innovation, creating flexible organisations and processes, and refocusing research and development to weather the current storm.

In a perfect world, leaders revealed they would investing in R&D and make the healthcare sector, regulatory and commercial environment work closer together to achieve better outcomes for patients and the pharmaceutical industry.

Stephen Whitehead, CEO, ABPI, says the survey shows more support is needed for biopharmaceutical companies in the ever-changing NHS. “There is much that the Government has done to support the industry, particularly through the Growth Review and the Office for Life Sciences,” he said. “But we need to build on this as part of a continuing relationship with NHS and Government to explore how unnecessary bureaucracy can be eliminated from the healthcare system so that new treatments can reach patients as quickly as possible.”

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

The idea that ‘any qualified provider’ can deliver NHS services may be contentious, but it has roots in existing policy. Thoreya Swage examines the opportunities for industry in the changing health provider landscape.

Successive governments have tried in recent years to shake up the healthcare system in the UK, with England probably being subject to the greatest number of changes. A key element of these shake-ups has been various attempts to expand the healthcare market in order to include the private or independent sector.

This widening of the doorway started in earnest with the deployment of the waiting list initiative in the 1990s, using the spare capacity of independent hospitals to reduce the queues for elective procedures that had built up in the NHS.

The baton was then taken up by the independent sector treatment programme under the last administration: the range of work done by private providers expanded to diagnostic procedures and screening programmes, as well as the construction of bespoke independent hospitals to take on hip, knee and cataract operations from the NHS.

It was at this stage that the concept of patients choosing which healthcare institution to go to for treatment or diagnostic procedures started to take off, with some of those options being in the independent sector. The idea of an ‘any willing provider’ began to take shape, with NHS care being delivered by any appropriate healthcare body as long as it had reached identified quality and safety standards.

However, before the recent change of government this initiative began to cool under external political pressure and at one time even seemed likely to fade away.

What AQP means

Despite opposition, the coalition Government has renewed the ‘any willing provider’ policy, calling it this time ‘any qualified provider’. In July of this year the Department of Health in England issued ‘operational guidance’ to the NHS providing further details to PCT clusters and the emerging Clinical Commissioning Groups (CCGs) – the renamed, modified GP consortia.

This policy has come under the guise of improving the quality of care by widening patient choice for specific services.

The intention is to permit the patient to choose from a list of qualified providers when they require a referral for a specific community or mental health service. To meet the ‘any qualified provider’ (AQP) requirement, a healthcare organisation needs to fulfil the quality, price and contractual obligations for NHS services. This process, as we have seen, is already in place for elective care.

The guidance states that the implementation of AQP will be conducted in phases from April next year. However, some work needs to be done before that. PCT clusters and their associated CCGs need to have decided which community or mental health services they wish to identify for the implementation of AQP locally by October, so that their patients can begin to have access to that care between April and September next year. Three or more services from the following list, drawn up by the DH in conjunction with patient groups, should be identified:

• musculo-skeletal services (neck and back pain)
• audiology services in the community (adults)
• continence care (adults and children)
• diagnostic services (e.g. imaging and heart and lung investigations)
• wheelchair services (children)
• podiatry services
• wound healing and management of leg ulcers
• primary care psychological therapies (adults).

The guidance also says that PCT clusters and CCGs can choose alternative services for AQP in different priority areas if these are supported by local patients – for example, as identified through the shadow health and wellbeing boards (the new joint health and social care joint commissioning boards) – and effective gains in quality and access can be made by doing so.

Getting involved

How can independent provider organisations participate in this process? The principles of the AQP approach are as follows:

• Organisations can qualify and register to provide NHS services as long as they meet NHS assurance requirements.
• Referral pathways and protocols set by CCGs must be accepted by the providers wishing to be on the AQP list.
• Patients are offered a choice of services from the list of qualified providers.
• There will be a fixed price based on a national or local tariff, to ensure that the provider is chosen by quality.

A national qualification process for all AQP providers is currently being developed by the DH in order to minimise bureaucracy and reduce transaction costs. The proposed principles for qualification are that providers:

• must be registered with the Care Quality Commission to demonstrate that they meet the essential standards for quality and safety (or equivalent assurance requirements if providing services not covered by CQC registration)
• are licensed by Monitor (from 2013) so that they are authorised to deliver NHS care
• can meet the terms and conditions of the NHS Standard Contract, including having regard for the NHS Constitution, appropriate guidance and legal obligations
• deliver care at NHS prices
• can meet the service specifications developed by commissioners and comply with referral protocols
• agree with the commissioners on any supporting schedules to the NHS Standard Contract, e.g. on activity levels.

More details of the qualification process will be published this autumn.

The providers that have successfully achieved the national qualification process will be listed in a directory available to GPs later this year.

By November 2011, lead PCT clusters will have produced detailed implementation packs for each service on the AQP list that will include service specifications, contract currencies, tariffs and information models.

It is anticipated that AQP for the services identified above will begin to be implemented from April 2012, with all CCGs having this in place for their patients by September 2012.

What happens next?

AQP will continue to expand: for 2013/14 a further list of services has been identified by the DH for discussion with commissioners, patient groups and providers. The list is not finalised, but will probably include:

• maternity care, e.g. antenatal education and support for breastfeeding
• speech and language therapy
• supporting patients to self-manage long-term conditions
• chemotherapy in the community setting and at home
• primary care psychological therapies for children and adolescents
• wheelchair services (adults).

Opportunities for medtech

The most obvious opportunity for medtech in relation to AQP is in the sphere of direct access diagnostic services, where many investigations such as non-obstetric ultrasound, echocardiography, cardiac physiology, MRI, X-ray, endoscopy and phlebotomy can be provided in the community setting, as indeed some already are (e.g. via Inhealth). These direct referrals can enable GPs to obtain rapid investigations and help to manage their patients in primary care, without having to refer to a hospital consultant.

Another key area is adult hearing services, including audiology and hearing aid fitting. Telehealth and telecare also have a part to play in supporting some of these services by monitoring people with long-term conditions at home. The services identified for the initial phase of AQP have traditionally had poor information systems. Better data collection on activity and health outcomes will be vital for the success of the providers delivering services under this initiative.

The key challenge for medtech companies is to get onto the recognised list of AQP that the DH is drawing up, or to work with partners who will be applying to go onto the list. Rather than regarding independent providers simply as customers, medtech suppliers can work with them to achieve AQP success.

Potential providers need to get up to speed on a number of areas, such as ensuring that they are registered with the CQC, have a good understanding of the standard NHS contract, offer services in keeping with the CCGs’ requirements and can manage within NHS financial envelopes.

The aim should be to identify the lead commissioner(s) within the local PCT cluster and associated CCGs and find out which community services they are planning to include on their local AQP. Alternatively, contacting the local shadow health and wellbeing board (if it is sufficiently developed) may indicate other priority areas for AQP. This is an opportunity for marketing medtech services that can be shown to improve patient care and are aligned with the local health economy’s priorities.

Medtech providers should also be clear about whether they can meet (or help their partner organisations meet) the qualification requirements for AQP. They should look closely at the details of these when they are published by the DH later this year.

Companies should also start doing their homework now on pricing and the care outcomes that can be achieved through their services, bearing in mind that the NHS commissioners will be looking at how the five high-level domains of the NHS Outcomes Framework will be achieved.

Another key milestone to look out for is the implementation packs due in November on service specifications, contract currencies, tariffs and information models. These will require close examination by potential providers seeking to ensure that they are fully prepared for AQP.

Although this initiative seems small in scale it looks set to grow in the future, and further opportunities will present themselves for 2013 and beyond as AQP continues to expand. For more information, visit the Department of Health website.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.