A Medical Device Daily

Ann Keen, the UK’s newly-named minister for patient empowerment, has called on the National Health Service (NHS) and local governments to give more people a greater say over local health and social care services.

Launching two new resources to help both the NHS and local authorities prepare for replacement of the current system of patient forums with Local Involvement Networks (LINks) next year, Keen said, “Services get better when they listen to the people that use them and respond to what they want. We know that the vast majority of people think that having a say in local health and social services is important, but we need more people to take an active role. For this to happen, getting involved must be simple and convenient.”

She added: “We will be engaging widely with local communities as part of the NHS Next Stage Review, and LINks are an important part in making sure that local people continue to play a central role in the design of local services.”

The first resource, “Planning your Local Involvement Network,” is a document that incorporates the findings from nine LINks “early adopter” sites. It sets out how local communities can prepare for LINks, such as the list of actions that local councils need to take, details of who needs to be involved in their establishment, and the resources required.

The second publication, “Contracting a host organization for your Local Involvement Network,” gives local authorities the information they need to procure a host organization that will establish and support a LINk. It includes information about the services a host will be required to provide and a guide to the process for establishing a network.

The nine LINks Early Adopter Projects are supported by the Commission for Patient and Public Involvement in Health and the Healthcare Commission.

Keen said that, although existing patient forums have helped to improve health and social care services in some areas, the new independent LINks “will simplify and strengthen the current system because they will have the power to hold NHS and social care commissioners to account. They will also be able to refer issues to local authority overview and scrutiny committees who can investigate and take action, such as summoning NHS managers for questioning, if required.”

She said LINks “have the potential to benefit everyone who uses health and social care services — whether by making it easy for people to share their views on services, or by giving them the opportunity to represent their communities. It will also be easier for councils and the NHS to engage with the often complex networks of patient activists, voluntary and community groups by helping local organizations to speak with one voice and have a real influence over key decisions.”

Keen said that local governments “must get planning underway now to avoid losing existing local expertise and to help the new LINks realize their full potential. I also urge the voluntary sector to get involved by sharing their experience.”

The Local Government and Public Involvement in Health Bill currently going through Britain’s Parliament includes proposals to streamline and modernize the current system by replacing just under 400 patient forums with 150 LINks, which are expected to become operational as of April 2008.

Baxter in flu vaccine agreement with UK

Baxter International (Deerfield, Illinois) said its European subsidiary in the UK has entered into an advanced supply agreement with the UK Department of Health that contains an option to purchase pandemic influenza vaccine in the event the World Health Organization (WHO; Geneva, Switzerland) declares a pandemic.

Baxter will manufacture its pandemic vaccine in a serum-free, vero cell-based system, at one of the largest cell culture vaccine facilities in the world.

The company said the use of vero cell culture, rather than conventional egg-based technology, offers several advantages. Its vero cell culture process can be initiated more rapidly due to the use of a “native” virus that does not need to be modified to allow growth in eggs, thus accelerating vaccine availability.

According to Baxter, vaccines produced using this process can be released within about 12 weeks, “significantly earlier than with traditional egg-based systems.” It said that all influenza strains with pandemic potential tested for growth in vero cells have produced replicable high yields, providing the company with the flexibility to quickly respond to emerging variant pandemic virus strains.

“We are [pleased] to provide the necessary technology, manufacturing capability and other resources to assist the Department of Health in its efforts to protect the UK population from the threat of a flu pandemic,” said Kim Bush, president of Baxter’s vaccines business.

Baxter said it is conducting clinical testing of the adjuvant-free candidate H5N1 (avian) influenza vaccine. A Phase I/II study in Europe indicated that study subjects administered the H5N1 vaccine developed “excellent antibody responses” at doses as low as 3.75microg and “substantial levels of cross-immunity” against widely divergent H5N1 strains.

The company said the study indicated that the tolerability profile of its H5N1 candidate “appeared to be similar to that of seasonal flu vaccines.” Baxter recently completed enrollment in a 550-subject Phase III trial of the H5N1 candidate vaccine for mock-up licensure in Europe, with data from that study expected to be available in late 2007.

Baxter said it is planning to initiate an additional large Phase III clinical study by that time that is intended to satisfy all European requirements for pre-pandemic licensure.