Meals

An interesting study of correlation rather than causation is provided by 'Pharmaceutical Industry–Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries' from Colette DeJong, Thomas Aguilar, Chien-Wen Tseng, Grace A. Lin, W. John Boscardin and R. Adams Dudley in (2016) JAMA Intern Medicine.

The authors comment 

 Importance

The association between industry payments to physicians and prescribing rates of the brand-name medications that are being promoted is controversial. In the United States, industry payment data and Medicare prescribing records recently became publicly available.

Objective

To study the association between physicians’ receipt of industry-sponsored meals, which account for roughly 80% of the total number of industry payments, and rates of prescribing the promoted drug to Medicare beneficiaries.

Design, Setting, and Participants

Cross-sectional analysis of industry payment data from the federal Open Payments Program for August 1 through December 31, 2013, and prescribing data for individual physicians from Medicare Part D, for all of 2013.

Participants were physicians who wrote Medicare prescriptions in any of 4 drug classes: statins, cardioselective β-blockers, angiotensin-converting enzyme inhibitors and angiotensin-receptor blockers (ACE inhibitors and ARBs), and selective serotonin and serotonin-norepinephrine reuptake inhibitors (SSRIs and SNRIs). We identified physicians who received industry-sponsored meals promoting the most-prescribed brand-name drug in each class (rosuvastatin, nebivolol, olmesartan, and desvenlafaxine, respectively).

Data analysis was performed from August 20, 2015, to December 15, 2015.

Exposures

Receipt of an industry-sponsored meal promoting the drug of interest.

Main Outcomes and Measures

Prescribing rates of promoted drugs compared with alternatives in the same class, after adjustment for physician prescribing volume, demographic characteristics, specialty, and practice setting.

Results

A total of 279 669 physicians received 63 524 payments associated with the 4 target drugs. Ninety-five percent of payments were meals, with a mean value of less than $20. Rosuvastatin represented 8.8% (SD, 9.9%) of statin prescriptions; nebivolol represented 3.3% (7.4%) of cardioselective β-blocker prescriptions; olmesartan represented 1.6% (3.9%) of ACE inhibitor and ARB prescriptions; and desvenlafaxine represented 0.6% (2.6%) of SSRI and SNRI prescriptions. Physicians who received a single meal promoting the drug of interest had higher rates of prescribing rosuvastatin over other statins (odds ratio [OR], 1.18; 95% CI, 1.17-1.18), nebivolol over other β-blockers (OR, 1.70; 95% CI, 1.69-1.72), olmesartan over other ACE inhibitors and ARBs (OR, 1.52; 95% CI, 1.51-1.53), and desvenlafaxine over other SSRIs and SNRIs (OR, 2.18; 95% CI, 2.13-2.23). Receipt of additional meals and receipt of meals costing more than $20 were associated with higher relative prescribing rates.

Conclusions and Relevance

Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.

FBI Biometrics

The US Government Accounting Office (GAO) has released a 68 page critique of FBI biometrics practice - FACE Recognition Technology:FBI Should Better Ensure Privacy and Accuracy.

The report examines:

1) the FBI's face recognition capabilities; and the extents to which

2) the FBI's use of face recognition adhered to privacy laws and policies and

3) the FBI assessed the accuracy of these capabilities. 

To address these questions, GAO reviewed federal privacy laws, FBI policies, operating manuals, and other documentation on its face recognition capability. GAO interviewed officials from the FBI and other federal and two state agencies that coordinate with the FBI on face recognition.

The report comments

The Department of Justice's (DOJ) Federal Bureau of Investigation (FBI) operates the Next Generation Identification-Interstate Photo System (NGI-IPS)— a face recognition service that allows law enforcement agencies to search a database of over 30 million photos to support criminal investigations. NGI-IPS users include the FBI and selected state and local law enforcement agencies, which can submit search requests to help identify an unknown person using, for example, a photo from a surveillance camera. When a state or local agency submits such a photo, NGI-IPS uses an automated process to return a list of 2 to 50 possible candidate photos from the database, depending on the user's specification. As of December 2015, the FBI has agreements with 7 states to search NGI-IPS, and is working with more states to grant access. In addition to the NGI-IPS, the FBI has an internal unit called Facial Analysis, Comparison and Evaluation (FACE) Services that provides face recognition capabilities, among other things, to support active FBI investigations. FACE Services not only has access to NGI-IPS, but can search or request to search databases owned by the Departments of State and Defense and 16 states, which use their own face recognition systems. Biometric analysts manually review photos before returning at most the top 1 or 2 photos as investigative leads to FBI agents.

DOJ developed a privacy impact assessment (PIA) of NGI-IPS in 2008, as required under the E-Government Act whenever agencies develop technologies that collect personal information. However, the FBI did not update the NGI-IPS PIA in a timely manner when the system underwent significant changes or publish a PIA for FACE Services before that unit began supporting FBI agents. DOJ ultimately approved PIAs for NGI-IPS and FACE Services in September and May 2015, respectively. The timely publishing of PIAs would provide the public with greater assurance that the FBI is evaluating risks to privacy when implementing systems. Similarly, NGI-IPS has been in place since 2011, but DOJ did not publish a System of Records Notice (SORN) that addresses the FBI's use of face recognition capabilities, as required by law, until May 5, 2016, after completion of GAO's review. The timely publishing of a SORN would improve the public's understanding of how NGI uses and protects personal information.

Prior to deploying NGI-IPS, the FBI conducted limited testing to evaluate whether face recognition searches returned matches to persons in the database (the detection rate) within a candidate list of 50, but has not assessed how often errors occur. FBI officials stated that they do not know, and have not tested, the detection rate for candidate list sizes smaller than 50, which users sometimes request from the FBI. By conducting tests to verify that NGI-IPS is accurate for all allowable candidate list sizes, the FBI would have more reasonable assurance that NGI-IPS provides leads that help enhance, rather than hinder, criminal investigations. Additionally, the FBI has not taken steps to determine whether the face recognition systems used by external partners, such as states and federal agencies, are sufficiently accurate for use by FACE Services to support FBI investigations. By taking such steps, the FBI could better ensure the data received from external partners is sufficiently accurate and do not unnecessarily include photos of innocent people as investigative leads.

The GAO comments that 

According to the FBI, [automated face recognition] technology can help law enforcement agencies identify criminals in their investigations. GAO was asked to review the FBI's use of face recognition technology. ... GAO is making six recommendations, including, that the Attorney General determine why PIAs and a SORN were not published as required and implement corrective actions, and for the FBI director to conduct tests to verify that NGI-IPS is accurate and take steps to determine whether systems used by external partners are sufficiently accurate for FBI's use. DOJ agreed with one, partially agreed with two, and disagreed with three of the six recommendations. In response, GAO clarified one recommendation, updated another recommendation, and continues to believe that all six recommendations remain valid as discussed further in this report.

It recommends

To improve transparency and better ensure that face recognition capabilities are being used in accordance with privacy protection laws and policy requirements, we recommend that the Attorney General:

• Assess the PIA development process to determine why PIAs were not published prior to using or updating face recognition capabilities, and implement corrective actions to ensure the timely development, updating, and publishing of PIAs before using or making changes to a system.

• Assess the SORN development process to determine why a SORN was not published that addressed the collection and maintenance of photos accessed and used through NGI for the FBI’s face recognition capabilities prior to using NGI-IPS, and implement corrective actions to ensure SORNs are published before systems become operational.

To better ensure that face recognition capabilities are being used in accordance with privacy protection laws and policy requirements, we recommend that the Director of the Federal Bureau of Investigation conduct audits to determine the extent to which users of NGI-IPS and biometric images specialists in FACE Services are conducting face image searches in accordance with CJIS policy requirements.

To better ensure that face recognition systems are sufficiently accurate, we recommend that the Director of the Federal Bureau of Investigation take the following three actions:

• Conduct tests of NGI-IPS to verify that the system is sufficiently accurate for all allowable candidate list sizes, and ensure that the detection and false positive rate used in the tests are identified.

• Conduct an operational review of NGI-IPS at least annually that includes an assessment of the accuracy of face recognition searches to determine if it is meeting federal, state, and local law enforcement needs and take actions, as necessary, to improve the system.

• Take steps to determine whether each external face recognition system used by FACE Services is sufficiently accurate for the FBI’s use and whether results from those systems should be used to support FBI investigations

Assaults

'The Legal Assault on Australian Democracy' by George Williams in (2016) 16(2) QUT Law Review comments 

Recent years have seen fierce public debate on whether Australia’s parliaments are passing laws that undermine fundamental democratic values, such as freedom of speech and freedom of association. Such debate has tended to focus on a few contentious laws, including s 18C of the Racial Discrimination Act 1975 (Cth), s 35P of the Australian Security Intelligence Organisation Act 1979 (Cth) and Queensland’s anti-bikie legislation. This article conducts a survey of the federal, state and territory statute books in order to determine whether such examples are isolated, or indicative of a broader trend. It identifies 350 instances of laws that arguably encroach upon rights and freedoms essential to the maintenance of a healthy democracy. Most of these laws have entered onto the statute book since September 2001. The article finds that the terrorist attacks of that month marked a watershed moment in the making of Australian laws, and that since that time parliamentarians have been less willing to exercise self-restraint by not passing laws that undermine Australia’s democratic system.

Neuroscience Commons

'The Greatest Generational Impact: The Open Neuroscience Movement as an Emerging Knowledge Commons' by Maja Larson and Margaret Chon in Brett Frischmann, Michael Madison and Katherine Strandburg (eds), Medical Commons (Cambridge University Press, 2017) describes

what some in the neuroscience research community are calling the “open neuroscience movement.” By focusing on the enabling conditions for cooperation, this case study of neuroscience data sharing may be particularly useful in illuminating the dynamics of commons formation in research environments dominated by an ethos of competitive, individual lab-based achievement. It also can shed light on the emergence of these types of governance arrangements where non-profit organizations are among the principal actors. Forthcoming in a collection of commons case studies analyzed under the Institutional Analysis and Development (IAD) framework, it is situated within the intersecting scholarly literatures on knowledge infrastructure and knowledge commons, both of which are related to open innovation research.

Patents

'The Surprising Resilience of the Patent System' (Stanford Public Law Working Paper No. 2784456) by Mark A. Lemley comments

 The patent system seems in the midst of truly dramatic change. The last twenty years have seen the rise of a new business model – the patent troll – that grew to become a majority of all patent lawsuits. They have seen a significant expansion in the number of patents granted and a fundamental change in the industries in which those patents are filed. They have seen the passage of the most important legislative reform in the last sixty years, a law that reoriented legal challenges to patents away from courts and toward the Patent and Trademark Office (PTO). And they have seen remarkable changes in nearly every important legal doctrine, from patent eligibility to obviousness to infringement to remedies. 

These changes have prompted alarm in a number of quarters. From the 1990s to the 2000s, as the number of patents and patent troll suits skyrocketed, technology companies and academics worried about the “crisis” in the patent system – a crisis of overprotection that might interfere with rather than promote innovation. By 2015, as patent reform took effect and the Supreme Court undid many of the Federal Circuit’s expansions of patent rights, it was patent owners who were speaking of a crisis in the patent system – a crisis of underprotection that might leave innovators without adequate protection. Depending on one’s perspective, then, the sky seems to have been falling on the patent system for some time. 

Despite the undeniable significance of these changes in both directions, something curious has happened to the fundamental characteristics of the patent ecosystem during this period: very little. Whether we look at the number of patent applications filed, the number of patents issued, the number of lawsuits filed, the patentee win rate in those lawsuits, or the market for patent licenses, the data show very little evidence that patent owners and challengers are behaving differently because of changes in the law. The patent system, then, seems surprisingly resilient to changes in the law. This is a puzzle. In this article, I document this phenomenon and give some thought to why the fundamental characteristics of the patent system seem resistant to even major changes in patent law and procedure. The results pose some profound questions not only for efforts at patent reform but for the role of the patent system in society as a whole.

ALRC Elder Abuse Inquiry

Questions from the ARLC issues paper regarding its inquiry into elder abuse -

What is elder abuse? 

Q 1 To what extent should the following elements, or any others, be taken into account in describing or defining elder abuse: harm or distress; intention; payment for services? 

Q 2 What are the key elements of best practice legal responses to elder abuse? 

Q 3 The ALRC is interested in hearing examples of elder abuse to provide illustrative case studies, including those concerning: Aboriginal and Torres Strait Islander people; people from culturally and linguistically diverse communities; lesbian, gay, bisexual, transgender or intersex people; people with disability; or people from rural, regional and remote communities. 

Q 4 The ALRC is interested in identifying evidence about elder abuse in Australia. What further research is needed and where are the gaps in the evidence? 

Social security 

Q 5 How does Centrelink identify and respond to people experiencing or at risk of experiencing elder abuse? What changes should be made to improve processes for identifying and responding to elder abuse? 

Q 6 What changes should be made to laws and legal frameworks relating to social security correspondence or payment nominees to improve safeguards against elder abuse? 

Q 7 What changes should be made to the laws and legal frameworks relating to social security payments for carers to improve safeguards against elder abuse? 

Q 8 What role is there for income management in providing protections or safeguards against elder abuse? 

Q 9 What changes should be made to residence requirements or waiting periods for qualification for social security payments, or the assurance of support scheme, for people experiencing elder abuse? 

Q 10 What other risks arise in social security laws and legal frameworks with regard to elder abuse? What other opportunities exist for providing protections and safeguards against abuse? 

Aged care 

Q 11 What evidence exists of elder abuse committed in aged care, including in residential, home and flexible care settings? 

Q 12 What further role should aged care assessment programs play in identifying and responding to people at risk of elder abuse? 

Q 13 What changes should be made to aged care laws and legal frameworks to improve safeguards against elder abuse arising from decisions made on behalf of a care recipient?   

Q 14 What concerns arise in relation to the risk of elder abuse with consumer directed aged care models? How should safeguards against elder abuse be improved? 

Q 15 What changes to the requirements concerning quality of care in aged care should be made to improve safeguards against elder abuse? 

Q 16 In what ways should the use of restrictive practices in aged care be regulated to improve safeguards against elder abuse? 

Q 17 What changes to the requirements for reporting assaults in aged care settings should be made to improve responses to elder abuse? 

Q 18 What changes to aged care complaints mechanisms should be made to improve responses to elder abuse? 

Q 19 What changes to the aged care sanctions regime should be made to improve responses to elder abuse? 

Q 20 What changes to the role of aged care advocacy services and the community visitors scheme should be made to improve the identification of and responses to elder abuse? 

Q 21 What other changes should be made to aged care laws and legal frameworks to identify, provide safeguards against and respond to elder abuse? 

The National Disability Insurance Scheme 

Q 22 What evidence exists of elder abuse being experienced by participants in the National Disability Insurance Scheme? 

Q 23 Are the safeguards and protections provided under the National Disability Insurance Scheme a useful model to protect against elder abuse? 

Superannuation 

Q 24 What evidence is there of older people being coerced, defrauded, or abused in relation to their superannuation funds, including their self-managed superannuation funds? How might this type of abuse be prevented and redressed? 

Financial institutions 

Q 25 What evidence is there of elder abuse in banking or financial systems? 

Q 26 What changes should be made to the laws and legal frameworks relating to financial institutions to identify, improve safeguards against and respond to elder abuse? For example, should reporting requirements be imposed? 

Family agreements 

Q 27 What evidence is there that older people face difficulty in protecting their interests when family agreements break down? 

Q 28 What changes should be made to laws or legal frameworks to better safeguard the interests of older people when family agreements break down? 

Appointed decision-makers 

Q 29 What evidence is there of elder abuse committed by people acting as appointed decision-makers under instruments such as powers of attorney? How might this type of abuse be prevented and redressed? 

Q 30 Should powers of attorney and other decision-making instruments be required to be registered to improve safeguards against elder abuse? If so, who should host and manage the register? 

Q 31 Should the statutory duties of attorneys and other appointed decision-makers be expanded to give them a greater role in protecting older people from abuse by others? 

Q 32 What evidence is there of elder abuse by guardians and administrators? How might this type of abuse be prevented and redressed? 

Public advocates 

Q 33 What role should public advocates play in investigating and responding to elder abuse? 

Q 34 Should adult protection legislation be introduced to assist in identifying and responding to elder abuse? 

Health services 

Q 35 How can the role that health professionals play in identifying and responding to elder abuse be improved? 

36 How should professional codes be improved to clarify the role of health professionals in identifying and responding to elder abuse? 

Q 37 Are health-justice partnerships a useful model for identifying and responding to elder abuse? What other health service models should be developed to identify and respond to elder abuse? 

Q 38 What changes should be made to laws and legal frameworks, such as privacy laws, to enable hospitals to better identify and respond to elder abuse? 

Forums for redress 

Q 39 Should civil and administrative tribunals have greater jurisdiction to hear and determine matters related to elder abuse? 

Q 40 How can the physical design and procedural requirements of courts and tribunals be improved to provide better access to forums to respond to elder abuse? 

Q 41 What alternative dispute resolution mechanisms are available to respond to elder abuse? How should they be improved? Is there a need for additional services, and where should they be located? 

Criminal law 

Q 42 In what ways should criminal laws be improved to respond to elder abuse? For example, should there be offences specifically concerning elder abuse? 

Q 43 Do state and territory criminal laws regarding neglect offer an appropriate response to elder abuse? How might this response be improved? 

Q 44 Are protection orders being used to protect people from elder abuse? What changes should be made to make them a better safeguard against elder abuse? 

Q 45 Who should be required to report suspected elder abuse, in what circumstances, and to whom? 

Q 46 How should the police and prosecution responses to reports of elder abuse be improved? What are best practice police and prosecution responses to elder abuse? 

Q 47 How should victims’ services and court processes be improved to support victims of elder abuse? 

Q 48 How should sentencing laws and practices relating to elder abuse be improved? 

49 What role might restorative justice processes play in responding to elder abuse? 

Q 50 What role might civil penalties play in responding to elder abuse?

EU Trade Secrets Directive

Specific features of the EU Trade Secrets Directive (backgrounded here) are -

Ch I - Subject matter and scope 

Article 1 - Subject matter and scope 

1. This Directive lays down rules on the protection against the unlawful acquisition, use and disclosure of trade secrets. Member States may, in compliance with the provisions of the TFEU, provide for more far-reaching protection against the unlawful acquisition, use or disclosure of trade secrets than that required by this Directive, provided that compliance with Articles 3, 5, 6, Article 7(1), Article 8, the second subparagraph of Article 9(1), Article 9(3) and (4), Article 10(2), Articles 11, 13 and Article 15(3) is ensured. 

2. This Directive shall not affect: (a) the exercise of the right to freedom of expression and information as set out in the Charter, including respect for the freedom and pluralism of the media; (b) the application of Union or national rules requiring trade secret holders to disclose, for reasons of public interest, information, including trade secrets, to the public or to administrative or judicial authorities for the performance of the duties of those authorities; (c) the application of Union or national rules requiring or allowing Union institutions and bodies or national public authorities to disclose information submitted by businesses which those institutions, bodies or authorities hold pursuant to, and in compliance with, the obligations and prerogatives set out in Union or national law; (d) the autonomy of social partners and their right to enter into collective agreements, in accordance with Union law and national laws and practices. 

3. Nothing in this Directive shall be understood to offer any ground for restricting the mobility of employees. In particular, in relation to the exercise of such mobility, this Directive shall not offer any ground for: (a) limiting employees' use of information that does not constitute a trade secret as defined in point (1) of Article 2; (b) limiting employees' use of experience and skills honestly acquired in the normal course of their employment; (c) imposing any additional restrictions on employees in their employment contracts other than restrictions imposed in accordance with Union or national law. 

Article 2 - Definitions 

For the purposes of this Directive, the following definitions apply: (1) ‘trade secret’ means information which meets all of the following requirements: (a) it is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question; (b) it has commercial value because it is secret; (c) it has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret; (2) ‘trade secret holder’ means any natural or legal person lawfully controlling a trade secret; (3) ‘infringer’ means any natural or legal person who has unlawfully acquired, used or disclosed a trade secret; (4) ‘infringing goods’ means goods, the design, characteristics, functioning, production process or marketing of which significantly benefits from trade secrets unlawfully acquired, used or disclosed. 

Ch II Acquisition, use and disclosure of trade secrets 

Article 3 Lawful acquisition, use and disclosure of trade secrets 

1. The acquisition of a trade secret shall be considered lawful when the trade secret is obtained by any of the following means: (a) independent discovery or creation; (b) observation, study, disassembly or testing of a product or object that has been made available to the public or that is lawfully in the possession of the acquirer of the information who is free from any legally valid duty to limit the acquisition of the trade secret; (c) exercise of the right of workers or workers' representatives to information and consultation in accordance with Union law and national laws and practices; (d) any other practice which, under the circumstances, is in conformity with honest commercial practices. 

2. The acquisition, use or disclosure of a trade secret shall be considered lawful to the extent that such acquisition, use or disclosure is required or allowed by Union or national law. 

Article 4 - Unlawful acquisition, use and disclosure of trade secrets 

1. Member States shall ensure that trade secret holders are entitled to apply for the measures, procedures and remedies provided for in this Directive in order to prevent, or obtain redress for, the unlawful acquisition, use or disclosure of their trade secret. 

2. The acquisition of a trade secret without the consent of the trade secret holder shall be considered unlawful, whenever carried out by: (a) unauthorised access to, appropriation of, or copying of any documents, objects, materials, substances or electronic files, lawfully under the control of the trade secret holder, containing the trade secret or from which the trade secret can be deduced; (b) any other conduct which, under the circumstances, is considered contrary to honest commercial practices. 

3. The use or disclosure of a trade secret shall be considered unlawful whenever carried out, without the consent of the trade secret holder, by a person who is found to meet any of the following conditions: (a) having acquired the trade secret unlawfully; (b) being in breach of a confidentiality agreement or any other duty not to disclose the trade secret; (c) being in breach of a contractual or any other duty to limit the use of the trade secret. 

4. The acquisition, use or disclosure of a trade secret shall also be considered unlawful whenever a person, at the time of the acquisition, use or disclosure, knew or ought, under the circumstances, to have known that the trade secret had been obtained directly or indirectly from another person who was using or disclosing the trade secret unlawfully within the meaning of paragraph 3. 

5. The production, offering or placing on the market of infringing goods, or the importation, export or storage of infringing goods for those purposes, shall also be considered an unlawful use of a trade secret where the person carrying out such activities knew, or ought, under the circumstances, to have known that the trade secret was used unlawfully within the meaning of paragraph 3. 

Article 5 - Exceptions 

Member States shall ensure that an application for the measures, procedures and remedies provided for in this Directive is dismissed where the alleged acquisition, use or disclosure of the trade secret was carried out in any of the following cases: (a) for exercising the right to freedom of expression and information as set out in the Charter, including respect for the freedom and pluralism of the media; (b) for revealing misconduct, wrongdoing or illegal activity, provided that the respondent acted for the purpose of protecting the general public interest; (c) disclosure by workers to their representatives as part of the legitimate exercise by those representatives of their functions in accordance with Union or national law, provided that such disclosure was necessary for that exercise; (d) for the purpose of protecting a legitimate interest recognised by Union or national law. 

Ch III - Measures, procedures and remedies 

Section 1 - General provisions 

Article 6 - General obligation 

1. Member States shall provide for the measures, procedures and remedies necessary to ensure the availability of civil redress against the unlawful acquisition, use and disclosure of trade secrets. 

2. The measures, procedures and remedies referred to in paragraph 1 shall: (a) be fair and equitable; (b) not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays; and (c) be effective and dissuasive. 

Article 7 - Proportionality and abuse of process 

1. The measures, procedures and remedies provided for in this Directive shall be applied in a manner that: (a) is proportionate; (b) avoids the creation of barriers to legitimate trade in the internal market; and (c) provides for safeguards against their abuse. 

2. Member States shall ensure that competent judicial authorities may, upon the request of the respondent, apply appropriate measures as provided for in national law, where an application concerning the unlawful acquisition, use or disclosure of a trade secret is manifestly unfounded and the applicant is found to have initiated the legal proceedings abusively or in bad faith. Such measures may, as appropriate, include awarding damages to the respondent, imposing sanctions on the applicant or ordering the dissemination of information concerning a decision as referred to in Article 15. Member States may provide that measures as referred to in the first subparagraph are dealt with in separate legal proceedings. 

Article 8 - Limitation period 

1. Member States shall, in accordance with this Article, lay down rules on the limitation periods applicable to substantive claims and actions for the application of the measures, procedures and remedies provided for in this Directive. The rules referred to in the first subparagraph shall determine when the limitation period begins to run, the duration of the limitation period and the circumstances under which the limitation period is interrupted or suspended. 

2. The duration of the limitation period shall not exceed 6 years. 

Article 9 - Preservation of confidentiality of trade secrets in the course of legal proceedings 

1. Member States shall ensure that the parties, their lawyers or other representatives, court officials, witnesses, experts and any other person participating in legal proceedings relating to the unlawful acquisition, use or disclosure of a trade secret, or who has access to documents which form part of those legal proceedings, are not permitted to use or disclose any trade secret or alleged trade secret which the competent judicial authorities have, in response to a duly reasoned application by an interested party, identified as confidential and of which they have become aware as a result of such participation or access. In that regard, Member States may also allow competent judicial authorities to act on their own initiative. The obligation referred to in the first subparagraph shall remain in force after the legal proceedings have ended. However, such obligation shall cease to exist in any of the following circumstances: (a) where the alleged trade secret is found, by a final decision, not to meet the requirements set out in point (1) of Article 2; or (b) where over time, the information in question becomes generally known among or readily accessible to persons within the circles that normally deal with that kind of information. 

2. Member States shall also ensure that the competent judicial authorities may, on a duly reasoned application by a party, take specific measures necessary to preserve the confidentiality of any trade secret or alleged trade secret used or referred to in the course of legal proceedings relating to the unlawful acquisition, use or disclosure of a trade secret. Member States may also allow competent judicial authorities to take such measures on their own initiative. The measures referred to in the first subparagraph shall at least include the possibility: (a) of restricting access to any document containing trade secrets or alleged trade secrets submitted by the parties or third parties, in whole or in part, to a limited number of persons; (b) of restricting access to hearings, when trade secrets or alleged trade secrets may be disclosed, and the corresponding record or transcript of those hearings to a limited number of persons; (c) of making available to any person other than those comprised in the limited number of persons referred to in points (a) and (b) a non-confidential version of any judicial decision, in which the passages containing trade secrets have been removed or redacted. The number of persons referred to in points (a) and (b) of the second subparagraph shall be no greater than necessary in order to ensure compliance with the right of the parties to the legal proceedings to an effective remedy and to a fair trial, and shall include, at least, one natural person from each party and the respective lawyers or other representatives of those parties to the legal proceedings. 

3. When deciding on the measures referred to in paragraph 2 and assessing their proportionality, the competent judicial authorities shall take into account the need to ensure the right to an effective remedy and to a fair trial, the legitimate interests of the parties and, where appropriate, of third parties, and any potential harm for either of the parties, and, where appropriate, for third parties, resulting from the granting or rejection of such measures. 

4. Any processing of personal data pursuant to paragraphs 1, 2 or 3 shall be carried out in accordance with Directive 95/46/EC. 

Section 2 - Provisional and precautionary measures 

Article 10 - Provisional and precautionary measures 

1. Member States shall ensure that the competent judicial authorities may, at the request of the trade secret holder, order any of the following provisional and precautionary measures against the alleged infringer: (a) the cessation of or, as the case may be, the prohibition of the use or disclosure of the trade secret on a provisional basis; (b) the prohibition of the production, offering, placing on the market or use of infringing goods, or the importation, export or storage of infringing goods for those purposes; (c) the seizure or delivery up of the suspected infringing goods, including imported goods, so as to prevent their entry into, or circulation on, the market. 

2. Member States shall ensure that the judicial authorities may, as an alternative to the measures referred to in paragraph 1, make the continuation of the alleged unlawful use of a trade secret subject to the lodging of guarantees intended to ensure the compensation of the trade secret holder. Disclosure of a trade secret in return for the lodging of guarantees shall not be allowed. 

Article 11 - Conditions of application and safeguards 

1. Member States shall ensure that the competent judicial authorities have, in respect of the measures referred to in Article 10, the authority to require the applicant to provide evidence that may reasonably be considered available in order to satisfy themselves with a sufficient degree of certainty that: (a) a trade secret exists; (b) the applicant is the trade secret holder; and (c) the trade secret has been acquired unlawfully, is being unlawfully used or disclosed, or unlawful acquisition, use or disclosure of the trade secret is imminent. 

2. Member States shall ensure that in deciding on the granting or rejection of the application and assessing its proportionality, the competent judicial authorities shall be required to take into account the specific circumstances of the case, including, where appropriate: (a) the value and other specific features of the trade secret; (b) the measures taken to protect the trade secret; (c) the conduct of the respondent in acquiring, using or disclosing the trade secret; (d) the impact of the unlawful use or disclosure of the trade secret; (e) the legitimate interests of the parties and the impact which the granting or rejection of the measures could have on the parties; (f) the legitimate interests of third parties; (g) the public interest; and (h) the safeguard of fundamental rights. 

3. Member States shall ensure that the measures referred to in Article 10 are revoked or otherwise cease to have effect, upon the request of the respondent, if: (a) the applicant does not institute legal proceedings leading to a decision on the merits of the case before the competent judicial authority, within a reasonable period determined by the judicial authority ordering the measures where the law of a Member State so permits or, in the absence of such determination, within a period not exceeding 20 working days or 31 calendar days, whichever is the longer; or (b) the information in question no longer meets the requirements of point (1) of Article 2, for reasons that cannot be attributed to the respondent. 

4. Member States shall ensure that the competent judicial authorities may make the measures referred to in Article 10 subject to the lodging by the applicant of adequate security or an equivalent assurance intended to ensure compensation for any prejudice suffered by the respondent and, where appropriate, by any other person affected by the measures. 

5. Where the measures referred to in Article 10 are revoked on the basis of point (a) of paragraph 3 of this Article, where they lapse due to any act or omission by the applicant, or where it is subsequently found that there has been no unlawful acquisition, use or disclosure of the trade secret or threat of such conduct, the competent judicial authorities shall have the authority to order the applicant, upon the request of the respondent or of an injured third party, to provide the respondent, or the injured third party, appropriate compensation for any injury caused by those measures. Member States may provide that the request for compensation referred to in the first subparagraph is dealt with in separate legal proceedings. 

Section 3 - Measures resulting from a decision on the merits of the case 

Article 12 - Injunctions and corrective measures 

1. Member States shall ensure that, where a judicial decision taken on the merits of the case finds that there has been unlawful acquisition, use or disclosure of a trade secret, the competent judicial authorities may, at the request of the applicant, order one or more of the following measures against the infringer: (a) the cessation of or, as the case may be, the prohibition of the use or disclosure of the trade secret; (b) the prohibition of the production, offering, placing on the market or use of infringing goods, or the importation, export or storage of infringing goods for those purposes; (c) the adoption of the appropriate corrective measures with regard to the infringing goods; (d) the destruction of all or part of any document, object, material, substance or electronic file containing or embodying the trade secret or, where appropriate, the delivery up to the applicant of all or part of those documents, objects, materials, substances or electronic files. 

2. The corrective measures referred to in point (c) of paragraph 1 shall include: (a) recall of the infringing goods from the market; (b) depriving the infringing goods of their infringing quality; (c) destruction of the infringing goods or, where appropriate, their withdrawal from the market, provided that the withdrawal does not undermine the protection of the trade secret in question. 

3. Member States may provide that, when ordering the withdrawal of the infringing goods from the market, their competent judicial authorities may order, at the request of the trade secret holder, that the goods be delivered up to the holder or to charitable organisations. 

4. The competent judicial authorities shall order that the measures referred to in points (c) and (d) of paragraph 1 be carried out at the expense of the infringer, unless there are particular reasons for not doing so. Those measures shall be without prejudice to any damages that may be due to the trade secret holder by reason of the unlawful acquisition, use or disclosure of the trade secret. 

Article 13 - Conditions of application, safeguards and alternative measures 

1. Member States shall ensure that, in considering an application for the adoption of the injunctions and corrective measures provided for in Article 12 and assessing their proportionality, the competent judicial authorities shall be required to take into account the specific circumstances of the case, including, where appropriate: (a) the value or other specific features of the trade secret; (b) the measures taken to protect the trade secret; (c) the conduct of the infringer in acquiring, using or disclosing the trade secret; (d) the impact of the unlawful use or disclosure of the trade secret; (e) the legitimate interests of the parties and the impact which the granting or rejection of the measures could have on the parties; (f) the legitimate interests of third parties; (g) the public interest; and (h) the safeguard of fundamental rights. Where the competent judicial authorities limit the duration of the measures referred to in points (a) and (b) of Article 12(1), such duration shall be sufficient to eliminate any commercial or economic advantage that the infringer could have derived from the unlawful acquisition, use or disclosure of the trade secret. 

2. Member States shall ensure that the measures referred to in points (a) and (b) of Article 12(1) are revoked or otherwise cease to have effect, upon the request of the respondent, if the information in question no longer meets the requirements of point (1) of Article 2 for reasons that cannot be attributed directly or indirectly to the respondent. 

3. Member States shall provide that, at the request of the person liable to be subject to the measures provided for in Article 12, the competent judicial authority may order pecuniary compensation to be paid to the injured party instead of applying those measures if all the following conditions are met: (a) the person concerned at the time of use or disclosure neither knew nor ought, under the circumstances, to have known that the trade secret was obtained from another person who was using or disclosing the trade secret unlawfully; (b) execution of the measures in question would cause that person disproportionate harm; and (c) pecuniary compensation to the injured party appears reasonably satisfactory. Where pecuniary compensation is ordered instead of the measures referred to in points (a) and (b) of Article 12(1), it shall not exceed the amount of royalties or fees which would have been due, had that person requested authorisation to use the trade secret in question, for the period of time for which use of the trade secret could have been prohibited. 

Article 14 - Damages 

1. Member States shall ensure that the competent judicial authorities, upon the request of the injured party, order an infringer who knew or ought to have known that he, she or it was engaging in unlawful acquisition, use or disclosure of a trade secret, to pay the trade secret holder damages appropriate to the actual prejudice suffered as a result of the unlawful acquisition, use or disclosure of the trade secret. Member States may limit the liability for damages of employees towards their employers for the unlawful acquisition, use or disclosure of a trade secret of the employer where they act without intent. 

2. When setting the damages referred to in paragraph 1, the competent judicial authorities shall take into account all appropriate factors, such as the negative economic consequences, including lost profits, which the injured party has suffered, any unfair profits made by the infringer and, in appropriate cases, elements other than economic factors, such as the moral prejudice caused to the trade secret holder by the unlawful acquisition, use or disclosure of the trade secret. Alternatively, the competent judicial authorities may, in appropriate cases, set the damages as a lump sum on the basis of elements such as, at a minimum, the amount of royalties or fees which would have been due had the infringer requested authorisation to use the trade secret in question. 

Article 15 - Publication of judicial decisions 

1. Member States shall ensure that, in legal proceedings instituted for the unlawful acquisition, use or disclosure of a trade secret, the competent judicial authorities may order, at the request of the applicant and at the expense of the infringer, appropriate measures for the dissemination of the information concerning the decision, including publishing it in full or in part. 

2. Any measure referred to in paragraph 1 of this Article shall preserve the confidentiality of trade secrets as provided for in Article 9. 3. In deciding whether to order a measure referred to in paragraph 1 and when assessing its proportionality, the competent judicial authorities shall take into account, where appropriate, the value of the trade secret, the conduct of the infringer in acquiring, using or disclosing the trade secret, the impact of the unlawful use or disclosure of the trade secret, and the likelihood of further unlawful use or disclosure of the trade secret by the infringer. The competent judicial authorities shall also take into account whether the information on the infringer would be such as to allow a natural person to be identified and, if so, whether publication of that information would be justified, in particular in the light of the possible harm that such measure may cause to the privacy and reputation of the infringer. 

Ch IV - Sanctions, reporting and final provisions 

Article 16 - Sanctions for non-compliance with this Directive 

Member States shall ensure that the competent judicial authorities may impose sanctions on any person who fails or refuses to comply with any measure adopted pursuant to Articles 9, 10 and 12. The sanctions provided for shall include the possibility of imposing recurring penalty payments in the event of non-compliance with a measure adopted pursuant to Articles 10 and 12. The sanctions provided for shall be effective, proportionate and dissuasive. 

Article 17 - Exchange of information and correspondents 

For the purpose of promoting cooperation, including the exchange of information, among Member States and between Member States and the Commission, each Member State shall designate one or more national correspondents for any question relating to the implementation of the measures provided for by this Directive. It shall communicate the details of the national correspondent or correspondents to the other Member States and the Commission. 

Article 18 - Reports 

1. By 9 June 2021, the European Union Intellectual Property Office, in the context of the activities of the European Observatory on Infringements of Intellectual Property Rights, shall prepare an initial report on the litigation trends regarding the unlawful acquisition, use or disclosure of trade secrets pursuant to the application of this Directive. 

2. By 9 June 2022, the Commission shall draw up an intermediate report on the application of this Directive, and shall submit it to the European Parliament and to the Council. That report shall take due account of the report referred to in paragraph 1. The intermediate report shall examine, in particular, the possible effects of the application of this Directive on research and innovation, the mobility of employees and on the exercise of the right to freedom of expression and information. 

3. By 9 June 2026, the Commission shall carry out an evaluation of the impact of this Directive and submit a report to the European Parliament and to the Council. 

Article 19 - Transposition 

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 9 June 2018. They shall immediately communicate the text of those measures to the Commission. When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive. 

Article 20 - Entry into force 

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.