Allens Biotech News is a fortnightly news service to keep you on top of developments in this fast-moving industry.
- Inappropriate disclosure of health information and access to medical records
- Company News
- BioTip: Secret use pitfalls
- Events
Inappropriate disclosure of health information and access to medical records
In brief: Lawyer Jacqueline Goodall reports on the outcome of three recent decisions by the federal Privacy Commissioner on the protection of health information under privacy law.
- L v Contractor to Australian Government Agency
- H v Health Service Provider
- K v Health Service Provider
- Conclusion
L v Contractor to Australian Government Agency
In L v Contractor to Australian Government Agency1, L made a complaint to the federal Privacy Commissioner (the Commissioner) alleging that a health-care provider, contracted to provide health services to L's employer, had improperly disclosed correspondence between L and the health-care provider to L's employer. The Commissioner investigated the matter under section 40(1) of the Privacy Act 1988 (Cth).
Disclosure of personal information to third parties is prohibited under the Privacy Act, unless certain circumstances exist, such as a person has consented to the disclosure or the disclosure is required or authorised by law.
The health-care provider admitted that it had contravened the Privacy Act and there were no lawful grounds for L's personal information to be disclosed to L's employer.
L accepted the health-care provider's offer to provide a written apology, to make a payment of compensation to L's chosen charity, to review its confidentiality policy and make the policy available to all staff. The Commissioner, satisfied that the complaint had been adequately addressed by the health-care provider, closed the complaint.
H v Health Service Provider
In H v Health Service Provider the Commissioner2, a medical centre disclosed the results of H's medical test to a third party. H initially pursued the matter with the medical centre, but not satisfied with its response, which was to reprimand the employee responsible for the disclosure, made a complaint to the Commissioner. The Commissioner investigated the matter under s40(1) of the Privacy Act.
As with the previous case, the starting position is that use or disclosure of personal information other than for the primary purpose of its collection is prohibited under the Privacy Act, unless certain circumstances exist. For example, disclosure is permitted if for a directly related secondary purpose within the individual's reasonable expectation. Further, an organisation must take reasonable steps to protect the personal information it holds from misuse and loss, and from unauthorised access, modification or disclosure.
The Commissioner found that the medical centre had used H's personal information, which had been collected for the purpose of providing a particular form of heath care, for a different, unrelated purpose that was in no way within H's reasonable expectations. Thus, it was found that the medical centre had disclosed H's personal information in contravention of the Privacy Act.
However, the Commissioner concluded the measures taken by the medical centre, including staff training, physical integrity, security, records-handling policy and staff-confidentiality agreements, could be reasonably expected to protect personal information it held. The staff member had departed from standard records-handling procedures. As regards the processes it had to protect personal information it held, the Commission found that the medical centre had complied with its obligations under the Privacy Act.
An offer of compensation without admission of liability was made by the medical centre and accepted by H. Satisfied that the medical centre had adequately dealt with the complaint, the Commissioner closed the matter.
K v Health Service Provider
In K v Health Service Provider3, a patient, K, sought a copy of two documents from the patient's medical records held by a medical centre.
The medical centre refused to provide K the documents for the following reasons:
- providing a copy of the first document would pose a risk to K's health;
- providing a copy of the second document, a letter from a family member to the medical centre, would have an unreasonable impact on the privacy of another person.
K complained to the Commissioner about the refusal to provide copies of the documents. The Commissioner investigated the matter under s40(1) of the Privacy Act.
Individuals have a right to access their own health information, unless
certain exceptions apply. For example, a person may be denied access to protect
the health or safety of the person or the privacy or another person.
The Commissioner engaged an independent medical consultant to judge whether the
first document posed a serious risk to K's health. The consultant found, and the
Commissioner agreed, that the first document posed no such threat. The medical
centre provided K with a copy of the document.
In determining whether access to the letter from the family member could be withheld, the Commissioner took into account that the family member had specifically requested that the information not be released and had not been informed of the possibility that the information may be released to K at a later time, and the fact that the information was not of a commonplace nature so its disclosure would have serious consequences for the family member and their relatives.
The Commissioner found that the medical centre was lawfully able to deny K access to the letter.
Conclusion
Privacy law provides individuals a general right to gain access to their own health information and protects them from unauthorised disclosure by organisations holding that information. However, there are limits on those rights and protections.
As was the case in L v Contractor to Australian Government Agency, a health-care provider cannot disclose a patient's health information to a person's employer, even when the health-care provider has been engaged to provide health services to the person by the employer. However, such disclosure would be permitted with the patient's consent.
As was the case in H v Health Service Provider, the use or disclosure of personal information other than for the primary purpose of its collection is prohibited. However, such disclosure may be lawful if it was for a directly related secondary purpose within the individual's reasonable expectation.
As was the case in K v Health Service Provider, individuals have a right to access their own health information, unless the information would impact on the privacy of another person.
Footnotes
Company news
In brief: Regular news from the biotech industry.
- Acrux announces marketing partner for Estradiol
- BioPharmica to spin-off brain anaesthesia arm
- GSK and Baxter to donate H5N1 vaccine to WHO
- Novogen and Chattm settle Isoflavone patent infringement case
- Schering Plough successful in class action
- Roche agrees to buy DNA microarray company NimbleGen for US$272.5 million
- Roche buy licensing rights to arthritis drug for up to US $370 million
- Sanofi Aventis and Bristol-Myers Squibb succeed in Plavix litigation
Acrux announces marketing partner for Estradiol
21 June – Australian biotech Acrux has announced a licensing agreement with the Australian subsidiary of Aspen Pharmacare to market the Estradiol MDTS spray for the treatment of menopause symptoms. This will be Acrux's first product in Australia and will use Acrux's unique hand-held spray technology for delivering drugs through the skin. Acrux expects to submit a marketing application to the Therapeutic Goods Administration in the third quarter of 2007, with the product expected to be available to Australian women in 2009. In the US, the Food and Drug Administration is currently reviewing the US branding of Estradiol, EvaMist, and, following FDA approval, KV Pharmaceutical will market EvaMist in the US.
[Source: Company announcement]
BioPharmica to spin-off brain anaesthesia arm
14 June – Perth-based biotech BioPharmica announced plans to spin off Cortical Dynamics, its anaesthesia technology arm. Under the spin-off plans, BioPharmica shareholders will receive a free share in Cortical Dynamics for every listed BioPharmica share held on 15 July. Cortical Dynamics is working in conjunction with Swinburne University of Technology in the development and commercialisation of an anaesthesia response monitoring system, which is designed to detect and record electrical activity of the human brain in order to keep patients optimally anaesthetised during surgery. The Brain Anaesthesia Response system will indicate how deeply anaesthetised a patient is. It is predicted that the depth of anaesthesia market will be worth A$1 billion by 2008.
[Source: Company announcement]
GSK and Baxter to donate H5N1 vaccine to WHO
13 June – In a response to a World Health Organisation (WHO) influenza pandemic stockpile initiative, GlaxoSmithKline (GSK) and Baxter have announced significant donations of influenza vaccine. GSK announced that it will donate 50 million doses of H5N1 adjuvanted pre-pandemic influenza vaccine, enough to inoculate 25 million people in the world's poorest countries. Baxter, in a statement, said they intend to support 'this program through the WHO by providing a multiyear donation of its candidate pandemic influenza vaccine. Donations to the program will help increase access to needed vaccines in the world's poorest countries in the event of a pandemic.' In May 2007, WHO announced that it would set up the international H5N1 vaccine stockpile. Additional measures being taken by WHO to prepare for a potential pandemic include rapid containment plans to stop a pandemic using both public health measures and anti-virals, and assistance to countries to increase vaccine production capacity.
[Source: Company and WHO announcement]
Novogen and Chattm settle Isoflavone patent infringement case
26 June – Australian biotech Novogen has announced a settlement on confidential terms of the legal action it had taken against Chattem Inc. The lawsuit had alleged that menopause products sold by Chattem infringed Novogen's US patents for health supplements containing isoflavones. Novogen has patented isoflavone technology for the treatment and prevention of degenerative diseases and disorders. In previous cases, Novogen has also enforced its isoflavone patent portfolio, reaching settlements against companies such as GNC, NBTY Inc, Natural Alternatives International, Swiss Herbal and WN Pharmaceuticals. Novogen's leading dietary supplement for the relief of menopausal symptoms is Promesil.
[Source: Company announcement]
Schering Plough successful in class action
21 June – Schering-Plough announced that the US District Court for the District of Massachusetts dismissed all claims relating to Schering- Plough's branded pharmaceutical products in a class action lawsuit involving the setting of wholesale prices for prescription products. Schering were also pleased that the court found no liability against its generic subsidiary, Warrick pharmaceuticals, for the period 1991 to 1997 and 2000 to 2003. The court did find limited liability against Warrick with respect to albuterol sulfate solution in 1998 and 1999, however the plaintiff's claim for damages for this formulation totalled less than US$100,000. Schering-Plough chairman and CEO Fred Hassan said, 'We are gratified that the hard work of our new management team has resulted in Schering-Plough putting another issue from the past substantially behind us.'
[Source: Company announcement]
Roche agrees to buy DNA microarray company NimbleGen for US$272.5 million
19 June – Swiss drugmaker Roche has agreed to acquire privately held NimbleGen Systems for US$272.5 million to boost its presence in the dynamic genomics research market. NimbleGen Systems is active in high-density DNA microarrays, widely used as a research tool to gain understanding of genetic causes of disease and predisposition factors, and to identify potential drug targets. The head of Roche's diagnostic unit, Severin Schwan, said that 'this acquisition represents a further milestone in our strategy to strengthen our position as a major player and complete solution provider in the genomics research market'. The transaction is expected to be completed in the third quarter of 2007, subject to approval by NimbleGen's shareholders and regulatory clearance. NimbleGen will become a fully integrated part of Roche Applied Science and Roche plans to maintain the current NimbleGen facilities in the US, Iceland and Germany. Roche said the global market for microarray systems was worth approximately US$600 million and grew by 10 per cent in 2006.
[Source: Company announcement]
Roche buy licensing rights to arthritis drug for up to US $370 million
25 June – Roche and Toyama Chemical Co announced that they have entered into a licensing agreement for the worldwide research, development and commercialisation of Toyama Chemical's oral rheumatoid arthritis agent T-5224. T-5224 inhibits a specific inflammatory process and has the potential to block signs and symptoms of rheumatoid arthritis, as well as the destruction of joints and bones. Toyama has granted Roche exclusive rights to research, develop, and sell T-5224 worldwide, excluding Japan. Toyama will receive upfront payments and milestone payments totalling up to US$370 million.
[Source: Company announcement]
Sanofi Aventis and Bristol-Myers Squibb succeed in Plavix litigation
19 June – The US District Court for the Southern District of New York has upheld the validity of Sanofi-Aventis' US patent covering clopidogrel bisulphate, the active ingredient in the blood-clot medication Plavix, jointly marketed by Sanofi-Aventis and Bristol-Myers Squibb. Plavix ranks second among the best-selling drugs in the world. The court also held that the Canadian generic drugmaker Apotex's generic clopidogrel bisulphate infringes the patent and has prohibited Apotex from marketing the product in the US until the patent expires. According to the decision, the patent is due to expire in 2011. Apotex has announced that it will appeal the decision.
[Source: Company announcement]
BioTip: Secret use pitfalls
It is reasonably well understood that the public disclosure of an invention before the filing of a patent application – including disclosure made by the inventor or applicant – has the potential to prevent valid patent protection. However, a lesser-known pitfall involves the secret commercial use of an invention prior to the filing of a patent application, which can prevent valid patent protection and can occur even if the invention has never been publicly disclosed. It is often possible to enter into commercial agreements or negotiations on the basis of what an invention can do or achieve without actually disclosing the invention itself. If such dealings are conducted prior to the filing of a patent application for the invention, then this action can be deemed a secret commercial use of the invention and thereby serve to preclude valid patent protection. It is, therefore, imperative to seek professional advice before entering into any commercial discussions relating to an invention or a prospective invention.
Events
Information on the latest conferences
See conferences in: July | August | September | November
BioMelbourne Network BioBreakfast
How biotechs can build value by accessing public research infrastructure
Tuesday, 10 July
The Supper
Room, Level 3, The Melbourne Town Hall, Melbourne
Contact: Nicole on 03 9650 8800 or
npitcher@biomelbourne.org
NEW – International Conference on
Bioinformatics
Monday, 27 August – Friday, 30 August
Hong Kong
http://incob.apbionet.org/incob07/
NEW – BIO Korea 2007
Wednesday, 12 September – Friday, 14 September
COEX, Seoul
http://www.biokorea.org/
Pharma Partnering Event – One-To-One License Meetings
Monday, 12
November – Tuesday, 13 November 2007
Hilton Hotel, Barcelona, Spain
http://www.pharmavenue.com/
Asian Patent Attorneys Association Annual Meeting
Saturday, 17
November – Tuesday, 20 November, 2007
Adelaide Convention Centre, South
Australia
http://www.apaa2007.com/
As active members of APAA, we look forward to attending what promises to be a very enjoyable and rewarding conference and, of course, to meeting many of our clients and contacts there. If you are planning to attend this meeting, please do take the opportunity to come and visit us in our Sydney or Melbourne office while you are in Australia. Let us know by getting in touch with Dr Trevor Davies (contact details set out below).
For further information, please contact:
- Michael DowlingConsultant,
Melbourne
Ph: +61 3 9613 8743
Michael.Dowling@aar.com.au - Dr Trevor DaviesPartner, Allens Arthur Robinson Patent & Trade Marks Attorneys,
Sydney
Ph: +61 2 9230 4007
Trevor.Davies@aar.com.au
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