02 September 2011

Trade Marks

IP Australia, the Australian counterpart of the USPTO, has released new figures on trade mark applications over the past decade.

Aggregate figures are -
FY - No.

2001/2 - 38,457
2002/3 - 42,058
2003/4 - 52,418
2004/5 - 57,211
2005/6 - 60,202
2006/7 - 65,899
2007/8 - 68,659
2008/9 - 61,002
2009/10 - 67,738
2010/11 - 69,003
NSW continues to dominate application activity, with a NSW versus Vic count over the same period as follows -
NSW - Vic

15,095 - 11,403
16,633 - 12,578
20,671 - 15,533
22,296 - 15,754
22,263 - 16,826
24,753 - 19,475
25,775 - 19,308
22,782 - 16,944
26,261 - 18,685
26,290 - 20,333
Applications in 2010/11 were as follows -
• Chemicals used in industry, science and photography, as well as in agriculture, horticulture and forestry; unprocessed artificial resins, unprocessed plastics; manures; fire extinguishing compositions; tempering and soldering preparations; chemical substances - 658
• Paints, varnishes, lacquers; preservatives against rust and against deterioration of wood; colorants; mordants; raw natural resins; metals in foil and powder form for painters, decorators, printers and artists - 241
• Bleaching preparations and other substances for laundry use; cleaning, polishing, scouring and abrasive preparations; soaps; perfumery, essential oils, cosmetics, hair lotions; dentifrices - 1621
• Industrial oils and greases; lubricants; dust absorbing, wetting and binding compositions; fuels (including motor spirit) and illuminants; candles and wicks for lighting - 251
• Pharmaceutical and veterinary preparations; sanitary preparations for medical purposes; dietetic substances adapted for medical use, food for babies; plasters, materials for dressings; material for stopping teeth, dental wax; disinfectants - 1449
• Common metals and their alloys; metal building materials; transportable buildings of metal; materials of metal for railway tracks; non-electric cables and wires of common metal; ironmongery, small items of metal hardware; pipes and tubes of metal; safes - 1266
• Machines and machine tools; motors and engines (except for land vehicles); machine coupling and transmission components (except for land vehicles); agricultural implements other than hand-operated; incubators for eggs - 991
• Hand tools and implements (hand-operated); cutlery; side arms; razors - 386
• Scientific, nautical, surveying, photographic, cinematographic, optical, weighing, measuring, signalling, checking (supervision), life-saving and teaching apparatus and instruments; apparatus and instruments for conducting, switching, transforming, ... - 4902
• Surgical, medical, dental and veterinary apparatus and instruments, artificial limbs, eyes and teeth; orthopedic articles; suture materials - 488
• Apparatus for lighting, heating, steam generating, cooking, refrigerating, drying, ventilating, water supply and sanitary purposes - 1319
• Vehicles; apparatus for locomotion by land, air or water - 1025
• Firearms; ammunition and projectiles; explosives; fireworks - 29
• Precious metals and their alloys and goods in precious metals or coated therewith, not included in other classes; jewellery, precious stones; horological and chronometric instruments - 646
• Musical instruments - 53
• Paper, cardboard and goods made from these materials, not included in other classes; printed matter; bookbinding material; photographs; stationery; adhesives for stationery or household purposes; artists materials; paint brushes; typewriters ... - 3659
• Rubber, gutta-percha, gum, asbestos, mica and goods made from these materials and not included in other classes; plastics in extruded form for use in manufacture; packing, stopping and insulating materials; flexible pipes, not of metal - 368
• Leather and imitations of leather, and goods made of these materials and not included in other classes; animal skins, hides; trunks and travelling bags; umbrellas, parasols and walking sticks; whips, harness and saddlery - 719
• Building materials (non-metallic); non-metallic rigid pipes for building; asphalt, pitch and bitumen; non-metallic transportable buildings; monuments, not of metal - 1037
• Furniture, mirrors, picture frames; goods (not included in other classes) of wood, cork, reed, cane, wicker, horn, bone, ivory, whalebone, shell, amber, mother-of-pearl, meerschaum and substitutes for all these materials, or of plastics - 1142
• Household or kitchen utensils and containers (not of precious metal or coated therewith); combs and sponges; brushes (except paint brushes); brush-making materials; articles for cleaning purposes; steelwool; unworked or semi-worked glass - 953
• Ropes, string, nets, tents, awnings, tarpaulins, sails, sacks and bags (not included in other classes); padding and stuffing materials (except of rubber or plastics); raw fibrous textile materials - 197
• Yarns and threads, for textile use - 45
• Textiles and textile goods, not included in other classes; bed and table covers - 621
• Clothing, footwear, headgear - 4116
• Lace and embroidery, ribbons and braid; buttons, hooks and eyes, pins and needles; artificial flowers - 181
• Carpets, rugs, mats and matting, linoleum and other materials for covering existing floors; wall hangings (non-textile) - 229
• Games and playthings; gymnastic and sporting articles not included in other classes; decorations for Christmas trees - 1687
• Meat, fish, poultry and game; meat extracts; preserved, dried and cooked fruits and vegetables; jellies, jams, compotes; eggs, milk and milk products; edible oils and fats - 1359
• Coffee, tea, cocoa, sugar, rice, tapioca, sago, artificial coffee; flour and preparations made from cereals, bread, pastry and confectionery, ices; honey, treacle; yeast, baking-powder; salt, mustard; vinegar, sauces (condiments); spices; ice - 1661
• Agricultural, horticultural and forestry products and grains not included in other classes; live animals; fresh fruits and vegetables; seeds, natural plants and flowers; foodstuffs for animals, malt - 773
• Beers; mineral and aerated waters and other non-alcoholic drinks; fruit drinks and fruit juices; syrups and other preparations for making beverages - 908
• Alcoholic beverages (except beers) - 1586
• Tobacco; smokers articles; matches - 72
• Advertising; business management; business administration; office functions - 8009
• Insurance; financial affairs; monetary affairs; real estate affairs - 143
• Building construction; repair; installation services - 2516
• Telecommunications - 1236
• Transport; packaging and storage of goods; travel arrangement - 1272
• Treatment of materials - 676
• Education; providing of training; entertainment; sporting and cultural activities - 6503
• Scientific and technological services and research and design relating thereto; industrial analysis and research services; design and development of computer hardware and software; legal services - 3615
• Services for providing food and drink; temporary accommodation - 1809
• Medical services; veterinary services; hygienic and beauty care for human beings or animals; agriculture, horticulture and forestry services - 2078
• Personal and social services rendered by others to meet the needs of individuals; security services for the protection of property and individuals - 1430

01 September 2011

Regulatory incapacity

The Australian National Audit Office (ANAO) has released a 198 page report on Therapeutic Goods Regulation: Complementary Medicines (ANAO Audit Report No.3 2011–121).

In essence the report [PDF] slams regulation by the Therapeutic Goods Administration (TGA), the Australian counterpart of the US FDA. It is eerily reminiscent of criticisms voiced over the past decade and in studies of 'light touch' pharmaceutical regulation such as the excellent Reputation & Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton University Press, 2010) by Daniel Carpenter.

The ANAO notes that -
Some two‐thirds of all Australians use complementary medicines — also known as ‘traditional’ or ‘alternative’ medicines— including vitamins, minerals, herbal, aromatherapy and homoeopathic products. Popular examples of complementary medicines in Australia include fish oil, St John’s Wort and glucosamine. These and many other complementary medicines are generally available for self‐medication by consumers. There are about 10 000 such medicines available on the Australian market. Consumption has continued to rise in recent years and, together with increasing exports of Australian‐manufactured complementary medicines, market growth has been estimated at between 3% and 12% a year. Sales of complementary medicines in Australia were estimated at $1.2 billion a year in 2010. Similar growth has been observed across other industrialised countries and the global market has been estimated at $US 83 billion annually.

Growth in the use of complementary medicines has been attributed to concerns about adverse effects from conventional drugs and the desire to pursue alternative treatments. These medicines are also widely considered to offer a gentler means of managing chronic conditions associated with greater life expectancy. However, there are potential risks as well as benefits in the use of all medicines, including complementary medicines, and this is recognised in Australia’s National Medicines Policy (NMP).

The community expects medicines on the Australian market to be safe, of good quality, effective and to be available promptly. The Commonwealth regulates complementary medicines, along with other therapeutic goods (medicines and medical devices) through the Therapeutic Goods Act 1989 (the Act). The object of the Act is to provide for a system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods. The Minister for Health & Ageing has responsibility for the Act and the
Therapeutic Goods Administration (TGA), part of the Department of Health & Ageing (DoHA), has the regulatory role.

The TGA has operated over the last two decades with an evolving regulatory framework. The Act has been amended frequently since it came into effect and the regulation of complementary medicines has changed, generally to provide easier market access for the low‐risk category of these products. An important development in this respect was the introduction, in 2001, of a system of self‐assessment for certifying that low‐risk complementary medicines satisfy the regulatory requirements that allow them onto the Australian market. Consistent with the view that such complementary medicines are low‐risk, this mechanism provides only limited assurance to the public about the characteristics of these medicines.

The TGA’s regulation of complementary medicines attracted attention in 2003 when it recalled more than 1600 products manufactured by Pan Pharmaceuticals, then Australia’s largest contract manufacturer of complementary medicines. The Government subsequently appointed the Expert Committee on Complementary Medicines in the Health System (the Expert Committee) to review the regulation of these medicines. The ANAO also undertook a performance audit of the TGA in 2004, focusing on the regulation of non-prescription medicines (which includes complementary medicines). The review and the audit report generated a number of recommendations for change, almost all of which were accepted.

A substantial change to the governance of therapeutic goods regulation was planned for mid-2006 with a project to introduce a joint regulatory agency for therapeutic products in both Australia and New Zealand. After extensive preparation, the project was suspended in mid‐2007 when the New Zealand Government announced it was not proceeding with the legislation. Regulation of complementary medicines was the stumbling block to implementing the joint scheme at this time. This initiative has recently been revived by the prime ministers of Australia and New Zealand.

The regulation of complementary medicines came to public attention in Australia when DoHA reported in late 2010 that, based on 2009–10 data, as many as 90 per cent of products reviewed were found to be non‐compliant with regulatory requirements, despite the system of self‐assessment by sponsors. Among the medicines the TGA reviewed, 31 were selected at random, for which the following compliance issues were recorded (with a number of products recording multiple breaches):
• 20 medicines had labelling issues such as non-compliance with labelling requirements and/or breaches which may mislead consumers.
• 12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
• 22 were found to have manufacturing and/or quality issues.
• 14 did not have adequate evidence to substantiate claims made about the medicines
A significant number of products subsequently required removal from the ARTG. This information was contained in DoHA’s incoming government brief, which was released to the public in late 2010. The information in the brief attracted significant interest and debate on the topic has persisted.
The ANAO concludes that -
The system for the regulation of complementary medicines in Australia was designed to have a ‘light touch’, due to the relatively low risk ascribed to the proper use of the majority of complementary medicines. The regulatory system has been further amended since its inception, twenty years ago, to ensure that market access for these products is not impeded unnecessarily. Because market access has been made easy, quick and low cost, an important safeguard to the integrity of the regulatory system is that easy entry be balanced by an effective post‐market monitoring of compliance with regulatory requirements that is commensurate with the relatively low risk profile of these products.

The results of TGA post-market monitoring in recent years have shown that non-compliance by sponsors of complementary medicines with regulatory requirements has been consistently high. In 2006, on the basis of a random sample, the TGA found a non‐compliance rate of 75%. DoHA has recently reported non‐compliance as high as 90% for the products reviewed. While the recent data is based on small sample sizes, making it difficult to gauge the magnitude of non‐compliance with any precision, TGA figures nevertheless show that a high level of non-compliance has endured for some years and that a substantial proportion of the cases of non‐compliance are categorised as ‘moderate’ or ‘significant’. The TGA has expressed concern that this situation presents potential risks to the public, the industry and confidence in the regulatory system. In this context, the available evidence indicates that the regulation of complementary medicines in Australia has been of limited effectiveness. The administration of the regulatory framework could be strengthened by the TGA making changes to improve the integrity of the self‐assessment process for pre‐market listing, using a risk‐based approach to better target its post‐market reviews, and improving the transparency of information available to consumers, health professionals and industry.

Listing new medicines was intended to be based largely on self-assessment by the sponsor of the medicine. However, risks arise in the operation of this self-assessment model because it permits inappropriate or misleading claims and indications to be made by sponsors through the deliberate or inadvertent entry of information in the ‘free‐text’ field of the TGA’s online Electronic Listing Facility (ELF). Given the importance of self‐assessment to listing new medicines, placing restrictions on the ability of sponsors to enter free text in ELF would mitigate the risks, while maintaining the promptness and ease of listing. The TGA is currently progressing work on a ‘coded indications’ project to this end and the ANAO has recommended that this project be finalised as soon as practicable.

At present, the TGA does not use in any systematic way the knowledge it gains from post‐market reviews of complementary medicines listed on the ARTG to identify and target consistent non‐compliance with the regulatory framework. There is a significant opportunity for the TGA to cost-effectively strengthen its post‐market review activities. Improved analysis of existing information could inform a more targeted and risk-based approach to monitoring non‐compliance. In particular, the ANAO recommends that the TGA use its random sampling review of listed medicines to develop risk profiles against the most significant characteristics of listed medicines and the less compliant sponsors and manufacturers. These profiles would inform the TGA’s targeted review strategy and enable it to direct efforts into improving compliance on a risk basis, whether through providing information or education to sponsors or, where necessary, through regulatory action. Against the background of 3000 sponsors and 10 000 listed medicines, a risk‐based approach to compliance monitoring has the benefit of directing limited resources to those products presenting the greatest risk of non‐compliance. The TGA could also benefit from developing a more active, but targeted, approach to monitoring compliance with advertising requirements, with options to be considered in the context of developing the risk profiles.

The Government’s recent review of the transparency of the regulatory framework was prompted by concern about the lack of information made available by the TGA about its regulatory processes and decisions. That review examined what information should be made more public and made recommendations about how that information could be better conveyed. The ANAO has concluded that transparency could be strengthened significantly by making information available in a timely manner to the Australian public for each listed complementary medicine, stating whether it has been subject to post‐market review, when, and the outcome of that review. The options for doing so include the provision of information on the TGA website, such as by adding fields to the publicly-viewable elements of the ARTG.

The most challenging aspect of regulating complementary medicines, which also affects the transparency of the system as a whole, is the public availability of evidence relating to their efficacy. It has been government policy since March 2005 that the TGA collect a summary of evidence from sponsors, an item which sponsors were required to hold when listing their medicine. The TGA developed an understanding that the requirement would be legislated in the context of the ANZTPA project but implementation faltered after the suspension of that project. In the course of the audit, the TGA advised that it had taken steps in May 2011 to restart implementation of this policy.

In summary, the regulatory framework for complementary medicines is important for consumers, health professionals and industry, and is now operating in the context of a growing domestic and international market with numerous sponsors and listed medicines. The effectiveness of the TGA’s administration of the framework would be improved by limiting the capacity which currently exists for sponsors to enter inappropriate claims as part of the pre‐market listing process, adopting a risk‐based approach to compliance monitoring and by implementing the existing government policy that the TGA collect a summary of evidence of efficacy for each listed complementary medicine. The public release of those summaries would have the further benefit of improving transparency by making relevant information available to consumers and health professionals about the effectiveness of complementary medicines. The ANAO has made five recommendations aimed at strengthening the integrity and transparency of the framework within existing policy settings, in large measure by refining the TGA’s existing systems and processes and better targeting the utilisation of resources.

31 August 2011

Jailhouse Frocks

One of the delights of teaching is being inspired to do additional research to encourage good students who asking smart questions of themselves and their peers. Tonight I've been avoiding a re-read of the judgment in Plaintiff M70/2011 v Minister for Immigration and Citizenship; Plaintiff M106 of 2011 v Minister for Immigration & Citizenship [2011] HCA 32 and instead looking at 'Jailhouse Frocks: Locating the Public Interest in Policing Counterfeit Luxury Fashion Goods' by David Wall and Joanna Large in 50(6) British Journal of Criminology (2010) 1094-1116.

The authors state that -
Motivated by enormous returns on investment from mark-ups that are potentially greater than drug trafficking and with low levels of perceived risk, the counterfeited goods industry has expanded considerably in recent years because of globalization and changes in consumer preferences. Commentators, including the US Bush Administration, have estimated that the market for counterfeit goods in the early twenty-first century constitutes between 5% and 7% of all world trade. The 2008 OECD report calculated that in 2005, the level of trade in counterfeit and pirated products was ‘up to’ $200 billion, with possibly ‘several several hundred billion dollars more’ if domestically produced and consumed counterfeit and pirated products and the significant volume of pirated digital products being distributed via the internet are also included in the estimation . Europe-wide, it reckoned that over 20% of the sales of clothing and shoes are counterfeit. Within the United Kingdom, the Rogers Review reported that criminal gain in 2006 from intellectual property crime (mainly counterfeits) was £1.3 billion, with £900 million flowing to organized crime.

Yet, comparatively little is known about counterfeiting, despite its apparent prevalence and the serious risks it poses for public safety and corporate stability, plus the alleged links to organized crime and the funding of terrorism. Even less is known about counterfeit luxury fashion goods, which, it will be argued, are significantly different in character from counterfeit safety-critical goods because of the different combinations of public and private interests that are involved. Such a distinction between the various interests will inform future anti-counterfeiting strategies and the maintenance of the United Kingdom's Intellectual Property (IP) Crime Strategy during a time when public sector spending is likely to decrease in real terms and demands for policing IP crime will increase. To emphasize this latter point, one of the three areas specifically recommended by the Labour Government's 2006 (Gowers) Review of Intellectual Property was to strengthen the enforcement of IP rights by clamping down on piracy and the trade in counterfeit goods. Informing the United Kingdom's IP strategy are statistics provided by the IP Crime Group's Annual IP Crime Report, which regularly shows a year-on-year increase in the level of IP Crime.

The topic of counterfeiting raises some interesting intellectual questions for criminologists, criminal justice policy makers and brand owners, not least because it differs from many of the regular types of offending that traditionally form the regular crime diet of the criminal justice system. It also differs because there is not a clear pattern of victimization and debates about counterfeiting oscillate between three victim groups. The first group are the consumers who may be exposed to health and safety risks from some counterfeit goods, but generally do not tend to see them as a problem because their primary focus is to spot a good bargain, which counterfeit goods represent to them. It is their insatiable desire for goods that display prestige brand marks that arguably inflates the unit value and creates the main market driver for counterfeiting. The second group regarded as victims are the owners of the goods or brands being counterfeited whose business is threatened. The third group are victims indirectly affected by adverse knock-on effects of the counterfeiting industry upon the environment or national taxation systems.

These contrasting positions not only shape criminal justice responses to counterfeiting, but they simultaneously blur its regulation and policing by creating confusion in the protection of private and public interests. Where, for example, do we draw the line between the responsibilities of consumers to act sensibly in their own interests; the responsibilities of IP owners to uphold their private corporate interests; and the responsibilities of governmental agencies (trading standards, the police and customs) to uphold the public interest? Core to these questions is whether or not the taxpayer should be funding anti-counterfeiting measures, or should the financial responsibility be thrown back to those whose goods are being counterfeited?

This article therefore explores where the public interest lies in the counterfeiting of luxury fashion goods. In so doing, it seeks to address a range of academic and practical questions relating to the regulation of intellectual property and contribute to the current debate about public spending on anti-counterfeit measures. It brings together a range of available literature and research mostly conducted for the fashion industry and further develops the UK findings of COUTURE, a two-year EU-funded project on the regulation of counterfeiting in the luxury fashion industry.

The first part sets out the range of issues found in contemporary debates over counterfeiting luxury goods before looking at the scale of counterfeiting. The second part considers what counterfeiting is and outlines the arguments that underpin policing interventions. The third part deconstructs the economics of branded luxury fashion goods in order to map out the criminology of desire for them and to consider how it shapes consumer behaviour. Such desire is the main incentive for counterfeiting and related criminal activity. The fourth part outlines the impact of counterfeiting luxury fashion goods upon the brand and society and explores links with organized crime. The fifth and final part considers the public and private interest implications of the above for policing counterfeiting.

Barbie's retroussé nose

From the 1709 Blog review of Infringement Nation: Copyright 2.0 and You (Oxford University Press 2011) by John Tehranian, promoted as "an engaging and accessible analysis of the history and evolution of copyright law and its profound impact on the lives of ordinary individuals in the twenty-first century" -
Books on copyright these days are very much like those doctor-and-nurse romances that used to be popular in the days when people didn't have to apologise for their poor taste in literature: they all have the same plot and the same ending. You know that, in approximate order, you are likely to encounter an explanation as to what copyright is, a nod to the fact that it was once regarded as serving a useful purpose, an account as to how it no longer addresses the day-to-day life of Joe Citizen even when he's not online or at the end of his hand-held device and how much more so when he is, a damning description of what some rogue personages - usually collective ones - do with the copyright when it's in their hands, concluding with the wise observation that something ought to be done about it. Some of these accounts are not great; others bounce along with the vigour of a John Grisham novel and also with the promise that, whatever twists the plot takes, the ending you hope for will generally be found in that place where endings are found. Given this author's experience, erudition and literary skills, this book is definitely at the upper end of this genre and will not disappoint. Indeed, it makes the reader wonder how we even put up with this tiresome inconvenience. This makes it all the more surprising to discover the existence of another book, from the stable of the same publisher, that shows just how effectively a combination of contract and, among other things, copyright law, can be wielded in order to preserve the old order which Professor Tehranian has so deftly painted.
Oxford indicates that -
organized around the trope of the individual in five different copyright-related contexts - as an infringer, transformer, pure user, creator and reformer - the book charts the changing contours of our copyright regime and assesses its vitality in the digital age. In the process, Tehranian questions some of our most basic assumptions about copyright law by highlighting the unseemly amount of infringement liability an average person rings up in a single day, the counterintuitive role of the fair use doctrine in radically expanding the copyright monopoly, the important expressive interests at play in even the unauthorized use of copyright works, the surprisingly low level of protection that American copyright law grants many creators, and the broader political import of copyright law on the exertion of social regulation and control.

Drawing upon both theory and the author's own experiences representing clients in various high-profile copyright infringement suits, Tehranian supports his arguments with a rich array of diverse examples crossing various subject matters - from the unusual origins of Nirvana's Smells Like Teen Spirit, the question of numeracy among Amazonian hunter-gatherers, the history of stand-offs at papal nunciatures, and the tradition of judicial plagiarism to contemplations on Slash's criminal record, Barbie's retroussé nose, the poisonous tomato, flag burning, music as a form of torture, the smell of rotting film, William Shakespeare as a man of the people, Charles Dickens as a lobbyist, Ashley Wilkes's sexual orientation, Captain Kirk's reincarnation, and Holden Caulfield's maturation. In the end, Infringement Nation makes a sophisticated yet lucid case for reform of existing doctrine and the development of a copyright 2.0.

Consent in EU data processing

The Article 29 Working Party has produced a 38 page Opinion (15/2011) [PDF] on the definition of 'consent' in relation to the European Data Protection Directive and e-Privacy Directive.

The Working Party is an independent European advisory body on data protection and privacy. It was established under Article 29 of Directive 95/46/EC. Its tasks are described in Article 30 of Directive 95/46/EC and Article 15 of Directive 2002/58/EC.

Last year the European Commission stated, in examining 'ways of clarifying and strengthening the rules on consent', that
When informed consent is required, the current rules provide that the individual's consent for processing his or her personal data should be a 'freely given specific and informed indication of his or her wishes by which the individual signifies his or her agreement to this data processing. However, these conditions are currently interpreted differently in Member States, ranging from a general requirement of written consent to the acceptance of implicit consent.

Moreover, in the online environment - given the opacity of privacy policies - it is often more difficult for individuals to be aware of their rights and give informed consent. This is even more complicated by the fact that, in some cases, it is not even clear what would constitute freely given, specific and informed consent to data processing, such as in the case of behavioural advertising, where internet browser settings are considered by some, but not by others, to deliver the user's consent.

Clarification concerning the conditions for the data subject's consent should therefore be provided, in order to always guarantee informed consent and ensure that the individual is fully aware that he or she is consenting, and to what data processing, in line with Article 8 of the EU Charter of Fundamental Rights. Clarity on key concepts can also favour the development of self-regulatory initiatives to develop practical solutions consistent with EU law.
The Opinion confirms that consent should be freely given, specific and informed, giving individuals enough detail to make a decision about how their personal data will be used. Where explicit consent is required to process sensitive personal data (such as health records) the Opinion indicates that an individual must expressly agree - whether orally or in writing - to the processing of the personal data. Consent on the basis of an individual's inaction is not sufficient. Individuals should also be able to withdraw their consent, preventing any further processing of their personal data.

The Working Party states that -
The Opinion provides a thorough analysis of the concept of consent as currently used in the Data Protection Directive and in the e-Privacy Directive. Drawing on the experience of the members of the Article 29 Working Party, the Opinion provides numerous examples of valid and invalid consent, focusing on its key elements such as the meaning of "indication", "freely given", "specific", "unambiguous", "explicit", "informed" etc.

The Opinion further clarifies some aspects related to the notion of consent. For example, the timing as to when consent must be obtained, how the right to object differs from consent, etc.

Consent is one of several legal grounds to process personal data. It has an important role, but this does not exclude the possibility, depending on the context, of other legal grounds perhaps being more appropriate from both the controller’s and from the data subject’s perspective. If it is correctly used, consent is a tool giving the data subject control over the processing of his data. If incorrectly used, the data subject’s control becomes illusory and consent constitutes an inappropriate basis for processing.

This Opinion is partly issued in response to a request from the Commission in the context of the ongoing review of the Data Protection Directive. It therefore contains recommendations for consideration in the review. Those recommendations include:
i) clarifying the meaning of “unambiguous” consent and explaining that only consent that is based on statements or actions to signify agreement constitutes valid consent;

ii) requiring data controllers to put in place mechanisms to demonstrate consent (within a general accountability obligation);

iii) adding an explicit requirement regarding the quality and accessibility of the information forming the basis for consent, and

iv) a number of suggestions regarding minors and others lacking legal capacity.
The Working Party comments -
Article 2 (h) of Directive 95/46/EC defines consent as "any freely given specific and informed indication of his wishes by which the data subject signifies his agreement to personal data relating to him being processed". Article 7 of the Directive, which sets forth the legal basis for processing personal data, sets out unambiguous consent as one of the legal grounds. Article 8 requires explicit consent as a legal ground to process sensitive data. Article 26.1 of Directive 95/46/EC and various provisions of the ePrivacy Directive require consent to carry out specific data processing activities within their scope of application. The points developed in this opinion aim at clarifying the various elements of this legal framework in an effort to make it easier to apply by stakeholders in general.

Elements/observations of general nature

• Consent is one of the six legal grounds to process personal data (one of five for sensitive data); it is an important ground as it gives some control to the data subject with regard to the processing of his data. The relevance of consent as an enabler of the individual’s autonomy and self-determination relies on its use in the right context and with the necessary elements.

• Generally speaking, the legal framework of Directive 95/46/EC applies whenever consent is sought, independently of whether this happens off-line or on-line. For example, the same rules apply when a bricks and mortar retailer seeks sign up for a loyalty card scheme via a paper form, as would be the case if it did this through its Internet site. In addition, the ePrivacy Directive specifies certain data processing operations which are subject to consent: they mostly relate to the processing of data in connection with the provision of publicly available electronic communication services. The requirements for consent to be valid within Directive 2002/58/EC are the same as under Directive 95/46/EC.

• Situations where data controllers use consent as a legal ground to process personal data should not be confused with situations where the controller bases the processing on other legal grounds which entail an individual right to object. For example, this may be the case when the processing relies on the 'legitimate interests' of the data controller ex Article 7(f) of Directive 95/46/EC, yet the individual has the right to object ex Article 14(a) of Directive 95/46/EC. Another example is when a data controller sends e-mail communications to existing clients in order to promote the data controller's own or similar products or services, however, individuals have a right to object under Article 13.2 of Directive 2002/58/EC. In both cases, the data subject has the right to object to the processing, this is not the same as consent.

• Reliance on consent to process personal data does not relieve the data controller from his obligation to meet the other requirements of the data protection legal framework, for example, to comply with the principle of proportionality under Article 6.1(c), security of the processing ex Article 17, etc.

• Valid consent presupposes individuals' capacity to consent. Rules regarding the capacity to consent are not harmonised and may therefore vary from Member State to Member State.

• Individuals who have consented should be able to withdraw their consent, preventing further processing of their data. This is confirmed also under the ePrivacy Directive for specific data processing operations based on consent, such as the processing of location data other than traffic data.

• Consent must be provided before the processing of personal data starts, but it can also be required in the course of a processing, where there is a new purpose. This is stressed in various provisions of Directive 2002/58/EC, either through the requirement "prior" (e.g. Article 6.3) or through the wording of the provisions (e.g. Article 5.3).

Specific elements of the legal framework related to consent

• For consent to be valid, it must be freely given. This means that there must be no risk of deception, intimidation or significant negative consequences for the data subject if he/she does not consent. Data processing operations in the employment environment where there is an element of subordination, as well as in the context of government services such as health may require careful assessment of whether individuals are free to consent.

• Consent must be specific. Blanket consent without determination of the exact purposes does not meet the threshold. Rather than inserting the information in the general conditions of the contract, this calls for the use of specific consent clauses, separated from the general terms and conditions.

• Consent must be informed. Articles 10 and 11 of the Directive lists the type of information that must necessarily be provided to individuals. In any event, the information provided must be sufficient to guarantee that individuals can make well informed decisions about the processing of their personal data. The need for consent to be "informed" translates into two additional requirements. First, the way in which the information is given must ensure the use of appropriate language so that data subjects understand what they are consenting to and for what purposes. This is contextual. The use of overly complicated legal or technical jargon would not meet the requirements of the law. Second, the information provided to users should be clear and sufficiently conspicuous so that users cannot overlook it. The information must be provided directly to individuals. It is not enough for it to be merely available somewhere.

• As to how consent must be provided, Article 8.2(a) requires explicit consent to process sensitive data, meaning an active response, oral or in writing, whereby the individual expresses his/her wish to have his/her data processed for certain purposes. Therefore, express consent cannot be obtained by the presence of a pre-ticked box. The data subject must take some positive action to signify consent and must be free not to consent.

• For data other than sensitive data, Article 7(a) requires consent to be unambiguous. "Unambiguous" calls for the use of mechanisms to obtain consent that leave no doubt as to the individual's intention to provide consent. In practical terms, this requirement enables data controllers to use different types of mechanisms to seek consent, ranging from statements to indicate agreement (express consent), to mechanisms that rely on actions that aim at indicating agreement.

• Consent based on an individual's inaction or silence would normally not constitute valid consent, especially in an on-line context. This is an issue that arises in particular with regard to the use of default settings which the data subject is required to modify in order to reject the processing. For example, this is the case with the use of pre-ticked boxes or Internet browser settings that are set by default to collect data.
It concludes that -
The Working Party considers that the current data protection framework contains a wellthought out set of rules that establish the conditions for consent to be valid in order to legitimise data processing operations. These apply in both the off- and on-line environments. More particularly:

The framework successfully achieves the balancing of a number of concerns. On the one hand, it ensures that only true, informed, consent is deemed as such. In this regard, Article 2(h) explicitly requiring consent to be freely given, specific and informed, is relevant and satisfactory. On the other hand, this requirement is not a straight jacket but it rather provides sufficient flexibility, avoiding technologically specific rules. This is illustrated in the same Article 2(h) where it defines consent as any indication of the individual’s wishes. This provides sufficient leeway in terms of the ways in which such an indication can be provided. Articles 7 and 8, requiring respectively unambiguous and explicit consent, capture well the need for a balance between the two concerns, giving flexibility and avoiding overly rigid structures while guaranteeing protection. The result is a framework which, if properly applied and implemented, is capable of keeping pace with the wide variety of data processing operations that often result from technological developments.

In practice however, establishing when consent is needed and more particularly the requirements for valid consent, including how to apply them concretely, is not always easy because of a lack of uniformity across Member States. Implementation at national level has resulted in different approaches. More specific shortcomings were identified during the discussions in the Article 29 Working Party that led to this Opinion, further described below.

Possible changes

• The notion of unambiguous consent is helpful for setting up a system that is not overly rigid but provides strong protection. While it has the potential to lead to a reasonable system, unfortunately, its meaning is often misunderstood or simply ignored. While the indications and examples developed above should contribute to enhancing the legal certainty and protection of individuals' rights when consent is used as a legal basis, the above situation seems to call for some amendments.

• More particularly, the Article 29 Working Party considers that the wording itself ("unambiguous") would benefit from further clarification as a part of the revision of the general data protection framework. Clarification should aim at emphasizing that unambiguous consent requires the use of mechanisms that leave no doubt of the data subject’s intention to consent. At the same time it should be made clear that the use of default options which the data subject is required to modify in order to reject the processing (consent based on silence) does not in itself constitute unambiguous consent. This is especially true in the on-line environment.

• In addition to the clarification described above, the Article 29 Working Party suggests the following:
i. First, include in the definition of consent of Article 2(h) the word “unambiguous” (or equivalent) in order to reinforce the notion that only consent that is based on statements or actions to signify agreement constitutes valid consent. In addition to adding clarity, this would align the concept of consent under Article 2(h) with the requirements for valid consent under Article 7. Moreover, the meaning of the word “unambiguous” could be further explained in a recital of the future legal framework.

ii. Second, in the context of a general accountability obligation, the controllers should be in a position to demonstrate that consent has been obtained. Indeed, if the burden of proof is reinforced so that data controllers are required to demonstrate that they have effectively obtained the consent of the data subject, they will be compelled to put in place standard practices and mechanisms to seek and prove unambiguous consent. The type of mechanisms will depend on the context and should take into account the facts and circumstances of the processing, more particularly its risks.
• The Article 29 Working Party is not convinced that the legal framework should require explicit consent as a general rule for all types of processing operations, including those currently covered by Article 7 of the Directive. It considers that unambiguous consent which encompasses explicit consent but also consent resulting from unambiguous actions should remain the required standard. This choice gives more flexibility to data controllers to collect consent and the overall procedure may be quicker and more user friendly.

• Several aspects of the legal framework that apply to consent are deduced from the wording, legal history or have been developed through case law and Article 29 Working Party Opinions. It would provide more legal certainty if such aspects were expressly built in the new data protection legislative framework. The following points could be taken into account:
i. The inclusion of an express clause setting up the right of individuals to withdraw their consent.

ii. The reinforcement of the notion that consent must be given before the processing starts, or before any further use of the data for purposes not covered by an initial consent, where there is no other legal ground for the processing.

iii. The inclusion of explicit requirements regarding the quality (obligation to provide information on data processing in a manner which is easy to understand, in clear and plain language) and accessibility of the information (obligation for the information to be conspicuous, prominent and directly accessible). This is vital for enabling individuals to make informed decisions.
• Finally, with regard to individuals lacking legal capacity, provisions ensuring enhanced protection could be foreseen, including:
i. Clarifications as to the circumstances in which consent is required from parents or representatives of an incapable individual, including the age threshold below which such consent would be mandatory.

ii. Laying down the obligation to use age verification mechanisms, which may vary depending on circumstances such as the age of children, the type of processing, whether particularly risky, and whether the information will be kept by the data controller or made available to third parties;

iii. A requirement for information to be adapted to children insofar as this would make it easier for children to understand what it means when data from them are collected, and thus deliver consent;

iv. Specific safeguards identifying data processing activities, such as behavioural advertising, where consent should not be a possible basis to legitimise the processing of personal data.

30 August 2011

Digital vigilantism

The New York Times reports that WikiLeaks, charmingly described as an "antisecrecy organization", is engaging in publication of unredacted US diplomatic cables as part of its release of around 134,000 leaked diplomatic cables in recent days. So much for respect for human dignity and care for individuals, presumably to be viewed as acceptable casualties in Julian Assange's crusade against the state.
A sampling of the documents showed that the newly published cables included the names of some people who had spoken confidentially to American diplomats and whose identities were marked in the cables with the warning “strictly protect.”

State Department officials and human rights activists have been concerned that such diplomatic sources, including activists, journalists and academics in authoritarian countries, could face reprisals, including dismissal from their jobs, prosecution or violence.

Since late 2010, The New York Times and several other news organizations have had access to more than 250,000 State Department cables originally obtained by WikiLeaks, citing them in news articles and publishing a relatively small number of cables deemed newsworthy. But The Times and other publications that had access to the documents removed the names of people judged vulnerable to retaliation.

WikiLeaks published some cables on its own Web site, but until the latest release, the group had also provided versions of the cables that had been edited to protect low-level diplomatic sources.

Government officials and journalists were poring over the newly released cables on Monday to assess whether people named in them might face repercussions. A quick sampling found at least one cable posted on Monday, from the American Embassy in Australia, had a name removed, but several others left in the identities of people whom diplomats had flagged for protection.

Among those named, despite diplomats’ warnings, were a United Nations official in West Africa and a foreign human rights activist working in Cambodia. They had spoken candidly to American Embassy officials on the understanding that they would not be publicly identified.
What's going on here? The Times continues that -
WikiLeaks said in a statement on Monday that the acceleration in disclosing the cables was “in accordance with WikiLeaks’s commitment to maximizing impact and making information available to all.” The statement suggested that it was intended to counter the “misperception” that the organization “has been less active in recent months.”

The statement said that “crowdsourcing” the documents by posting them will allow people of different backgrounds and nationalities to interpret the cables. It was unsigned, but WikiLeaks’s founder, Julian Assange, generally drafts or approves the group’s statements.
Let's not allow human rights to get in the way of Wikileaks' profile!
Last year, WikiLeaks was sharply criticized by human rights activists for disclosing the names of Afghan citizens who had provided information on the Taliban to the American military. It was far more cautious in subsequent releases, using software to strip proper names out of Iraq war documents and publishing versions of the cables after they had been edited by The New York Times and other publications. ...

the State Department has always acted on the assumption that all quarter-million cables might become public. A department task force worked with American embassies to review all the leaked cables, quietly warning people named in the cables that they might be in jeopardy. Some especially vulnerable people were given help to move, usually outside their home countries.

Steven Aftergood, an expert on government secrecy at the Federation of American Scientists, said he had reviewed several dozen cables from the new batch — all among those classified “secret” by the State Department — and found only one redaction. He said the volume of the new release made it unlikely that all the information that might endanger diplomatic sources had been removed.

“If these cables have not been carefully reviewed, it’s likely to be problematic for any number of people named in the cables,” Mr. Aftergood said.

29 August 2011

419 Scam

The Australian Institute of Criminology has released 'Risk factors for advance fee fraud victimisation' (Trends & issues in crime and criminal justice no.420) [PDF] by Stuart Ross & Russell Smith, examining "the characteristics of a sample of victims of advance fee frauds to determine how their behaviour and personal circumstances might have contributed to their willingness to respond to unsolicited invitations and to their subsequent loss of money or personal information". It's a welcome addition to the literature on the '419' or 'Nigerian' scam, the latest iteration of traditional frauds such as the 'Spanish Prisoner' scam popular in early modern Europe.

The authors comment that -
Advance fee scams come in many guises. Some regularly seen examples involve:
• offers to participate in business deals with wealthy individuals;
• assisting dignitaries by paying fees to move large sums of money out of a foreign country in order to receive a share of the proceeds;
• paying fees in order to receive lottery winnings, an inheritance or some other prize; or
• paying money to develop a personal relationship or marriage with someone met online.
In each case, the motivation behind the deception is to secure a payment from the victim which is paid in the expectation that a substantial benefit will follow. Of course, this fails to eventuate and the victim is left without the anticipated reward and without the funds paid in advance. Effective prevention of, and law enforcement responses to, such crimes are problematic. This form of fraud is often associated with offenders based in West Africa (and in particular Nigeria) but is now geographically widespread. The use of electronic communications makes it extremely difficult to prevent scammers from reaching potential victims, and the ability of the scammers to conduct their operations anonymously from cells in a variety of countries means that few offenders are arrested and prosecuted. ...

Rather than selecting potential victims on the basis of their observed wealth or ability to pay, such as occurs with corporate fraudsters or burglars, advance fee fraud offenders disseminate millions of invitations randomly in the expectation that a small number will respond and be available for victimisation, sometimes following a convoluted process of trust-building and deception. This process entails offenders understanding the psychology of their intended victims and adapting their strategies accordingly. Victims may continue the fraudulent relationship even after they have lost considerable sums and be unwilling to desist even in the face of clear and compelling evidence that the activity is fraudulent.

Not everyone is at risk of becoming a victim of fraud despite the wide net being cast. Rather, it is the behaviour of the consumer that is important in determining whether or not a person is taken in by a scam (Holtfreter, Reisig & Pratt 2008). Two theoretical approaches have been used to understand how people are victimised. One involves consideration of the behaviours that increase the risk of potential victimisation and the other examines the choices and decision-points of people who are exposed to fraudulent offers.
In response, the AIC, Victoria Police and University of Melbourne surveyed a sample of people who had sent money to Nigeria. That sample was identified by Victoria Police personnel using financial intelligence from the Australian Transaction Reports & Analysis Centre (AUSTRAC), covering Ipeople living in Victoria who had transferred money to Nigeria using an international funds transfer service during the 12 month period from 1 April 2007 to 31 March 2008. Yes, government does watch money flows

Victoria Police sent a questionnaire to 1,410 such people in September 2008, with follow-up letters a month later. 202 responses were received (ie a response rate of 14.3%). The surveys were anonymous,. Respondents were invited to participate in follow-up interviews by calling the AIC; three such interviews were conducted. (Disappointingly, "the findings were not included in the current report owing to limitations of space".)

Of the survey respondents, 54.5% were male, with the highest proportions aged 35–44 years (31%), having completed secondary schooling (32%) and having an income of under $20,000 (28%). Of the 202 responses to the survey, 120 (59%) were identified as victims of advance fee fraud. The remaining 41% were non-victims and were mainly people who said they had sent money to family or friends or had made donations to agencies in Nigeria. The authors comment that "this high rate of victimisation is itself an interesting finding and suggests that this approach could be used to identify individuals who should receive advice about the risks involved in transferring funds to high-risk destination countries in the future".

More than a quarter of victims had responded to invitations concerning online transactions, charitable donations and job-related scams, while the remainder were classified as having responded to ‘other’ types of advance fee invitations which included lottery scams. three-quarters of victims had sent money to offenders on more than one occasion and over 40 percent had sent money five or more times. Some respondents either could not remember or were not prepared to say how much they had sent. Of those who did nominate an amount sent, the totals ranged from $100 to $120,000, with a mean of around $12,000. Most of the money came from personal savings: 80 % of victims nominated this as the source of the money they sent but some people took out a personal loan (13%) or borrowed money from family or friends to send (10%). A small proportion of victims (5%) had mortgaged property in order to raise funds to send to the fraudsters.