Emergent BioSolutions Inc. (NYSE:EBS) announced today that the Singapore Health Sciences Authority (HSA) has approved Emergent's product license application for the marketing and sale of BioThrax® (Anthrax Vaccine Adsorbed) in Singapore. BioThrax is the only vaccine licensed by the U.S. Food and Drug Administration (FDA) to protect against anthrax infection. "Emergent is pleased with this development as it continues to grow its presence in the Pacific Rim," said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. "With HSA approval of BioThrax, we look forward to initiating discussions with the government of Singapore, as well as other allied governments that recognize HSA registered products such as Brunei, to help protect their constituents against the threat of anthrax as a biological weapon." HSA is the statutory board of the Singapore Ministry of Health that administers the country's regulatory framework for pharmaceuticals, complementary medicines, medical devices and other health products. Its vision is to be the leading innovative authority that protects and advances national health and safety in Singapore. About BioThrax BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 42 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 10 million doses have been administered to more than 2.5 million military personnel.

Doctors must not disregard confidentiality guidance when considering whether to report concerns about patients they suspect may be involved in terrorism.

The UK-wide medical defence organisation MDDUS is issuing the warning following the publication yesterday of a revised government counter-terrorism programme. The Prevent strategy asks doctors and other healthcare workers to help identify people who are "vulnerable to radicalisation" and to help them "access the relevant support". It states that people with mental health issues or learning disabilities "may be more easily drawn into terrorism."

Prevent compares efforts to stop someone from becoming involved in terrorism to safeguarding in other areas, including child abuse or domestic violence. Since January 2010, Prevent has piloted in nine Strategic Health Authority regions in England where frontline workers have been given training and guidance. A key section of the strategy for doctors states:

"The key challenge for the healthcare sector is to ensure that, where there are signs that someone has been or is being drawn into terrorism, the healthcare worker can interpret those signs correctly, is aware of the support which is available and is confident in referring the person for further support."

The strategy states that the Prevent pilot is "improving channels of communication between the health sector and the police, as well as other cross-agency links".

But MDDUS medical adviser Dr Anahita Kirkpatrick says doctors should not forget their duty of confidentiality. She says: "Any doctor considering disclosing confidential information about a patient who they suspect may be involved in terrorism or extremist activities should be very sure of their facts and be prepared to justify their actions if called to do so.

"It is important that doctors consult the GMC guidance on confidentiality. They must carefully consider the facts and consider discussing with a senior colleague and weigh the potential harms that are likely to arise from non-disclosure of information, against the possible harm, both to the patient and to the overall trust between doctors and patients, arising from the release of that information. Reasons for making a disclosure should be noted in the patient's record. The disclosure should be the minimum necessary confidential information."

GMC guidance makes it clear that confidential patient information can only be disclosed without consent in exceptional circumstances, "if failure to do so may expose others to a risk of death or serious harm".

Doctors are usually expected to inform patients if a disclosure has been made without their consent. But in cases of suspected terrorism a doctor may be justified in not doing so if it would put them or others at risk of serious harm, or would prejudice the purpose of the disclosure. Once the decision to disclose has been made, it should be carried out in a timely fashion to an appropriate person or authority.

The revised Prevent programme acknowledges the importance of maintaining patient trust. It says the Department of Health will need to ensure that the "crucial relationship of trust and confidence between patient and clinician" is balanced with the healthcare worker's duty to consider public safety. The strategy calls for clear guidelines to be drawn up for healthcare workers "to ensure that cases of radicalisation whether among staff or patients are given the attention and care they deserve."

Dr Kirkpatrick adds: "MDDUS urges all doctors to be aware of the implications of the government's revised Prevent programme. But bear in mind that doctors are not expected to go looking for evidence of terrorism plots. They would only be expected to act on information they come across as part of their normal interactions with patients.

"If there is any doubt about disclosing confidential information, they should seek clarification from their medical defence organisation."