08 May 2018

National Security, Risk and Migration Vetting

'Extreme Vetting of Immigrants: Estimating Terrorism Vetting Failures', a Cato study by David J. Bier, comments
President Donald Trump has promised to implement “extreme vetting” of immigrants and foreign travelers, asserting that wide-spread vetting failures had allowed many ter- rorists to enter the United States. This policy analysis provides the first estimate of the number of ter- rorism vetting failures, both before and after the vetting enhancements implemented in response to the September 11, 2001, attacks. Vetting failures are rare and have become much rarer since 9/11.
A terrorism vetting failure occurs when a foreigner is granted entry to the United States who had terrorist associations or sympathies and who later committed a terrorism offense including support for terrorist groups abroad. This analysis defines vetting failure broadly to include individuals who had privately held extremist views before entry. Moreover, unless evidence exists to the contrary, it assumes that anyone who entered the United States legally either as an adult or older teenager, and who was charged with a terrorism offense within a decade of entry, entered as a result of a vetting failure, even without any evidence that he or she was radicalized prior to entry.
By this definition, only 13 people — 2 percent of the 531 individuals convicted of terrorism offenses or killed while committing an offense since 9/11 — entered due to a vetting failure in the post-9/11 security system. There were 52 vetting failures in the 15 years leading up to 9/11, four times as many as in the 15 years since the attacks. From 2002 to 2016, the vetting system failed and permitted the entry of 1 radicalized terrorist for every 29 million visa or status approvals. This rate was 84 percent lower than during the 15-year period leading up to the 9/11 attacks. Only 1 of the 13 post-9/11 vetting failures resulted in a deadly attack in the United States. Thus, the rate for deadly terrorists was 1 for every 379 million visa or status approvals from 2002 through 2016.
During this same period, the chance of an American being killed in an attack committed by a terrorist who entered as a result of a vetting failure was 1 in 328 million per year. The risk from vetting failures was 99.5 percent lower during this period than during the 15-year period from 1987 to 2001. The evidence indicates that the U.S. vetting system is already “extreme” enough to handle the challenge of foreign terrorist infiltration.

Homeopathy in Australian Pharmacies

The national Government has released its response to last year's Final Report of the Review of Pharmacy Remuneration and Regulation.

The response is of particular interest for disengagement regarding the sale and promotion of homeopathic products, which - as noted in a range of authoritative studies highlighted in this blog (eg here and here) - have no therapeutic efficacy apart from the placebo effect. It is disquieting that pharmacists continue to sell 'medications' in which it is impossible to detect a pharmacologically active agent. That practice, and the Commonwealth's response (an embodiment of regulatory capture), tells us something useful about health policy and about regulation, which we can contextualise through reference to the failures of ASIC, TGA, APRA and the OAIC evident in current reporting of for example the Hayne Royal Commission.

The response states
The Government responds to the Report in accordance with meeting its obligations under the Sixth Community Pharmacy Agreement (6CPA). The independent Review upholds a commitment made between the Australian Government and the Pharmacy Guild of Australia (the Guild), during negotiations of the 6CPA in 2015, to conduct a comprehensive review of pharmacy remuneration and regulation.
The Terms of Reference for the Review provided that it would make recommendations on the future remuneration, regulation including pharmacy location rules and other arrangements that apply to pharmacy and wholesalers for the dispensing of medicines and other services, including preparation of infusions or injections for chemotherapy, provided under the Pharmaceutical Benefits Scheme (PBS), to ensure consumers have reliable and affordable access to medicines.
In November 2015, the then Minister for Health, the Hon Sussan Ley MP, appointed Professor Stephen King to chair a panel of three eminent independent reviewers to undertake the Review. Other members appointed to the Review Panel were Ms Jo Watson and Mr Bill Scott. The Government acknowledges the comprehensive consultation, analysis and strategic thinking undertaken by the Review Panel in delivering the Report.
The Government notes that the Report has been informed by an extensive public consultation process and gratefully acknowledges the input of all individuals and organisations who contributed their knowledge, expertise and vision to the Review.
The Report notes that Australia’s pharmacy sector is evolving and adapting to change – it is in the midst of transition from a product supply focus to one which is more patient-centred and adaptive to an outcomes-based approach to the optimal use of medicines – and that this trend is also occurring internationally.
The Government notes that a number of recommendations of the Review complement work that has already been undertaken, or is in progress by Government and/or other organisations, agencies or jurisdictions to progress issues that support community pharmacy with this transition. Other recommendations of the Review will require further investigation by Government. The Government recognises the pivotal role of the community pharmacy sector in delivering medicines to Australian patients. The Government is committed to working closely with community pharmacies and other stakeholders to address the significant pressures being placed on the health system, including a growing burden of chronic disease, an ageing population, and growing demand for high-cost, high-tech services and breakthrough medicines.
xxx The 6CPA between the Government and the Guild provides approximately $18.9 billion to more than 5,700 community pharmacies for dispensing PBS medicines, providing pharmacy programs and services and for the Community Service Obligation (CSO) arrangements with pharmaceutical wholesalers.
The 6CPA, which operates until 30 June 2020, supports Australia’s National Medicines Policy and the sustainability of the PBS, contributes to the Government’s investment in new medicine listings (since coming into Government in September 2013, the Coalition has added around $8.2 billion worth of medicines to the PBS) and provides greater certainty of Government revenue to community pharmacies, in an environment of ongoing medicine price reductions associated with price disclosure.
In May 2017, the Government entered into a compact with the Guild to strengthen the PBS. As part of the 2017-18 Budget measure Improving Access to Medicines – support for community pharmacies, the Government is providing $825 million over three years from 2017–18 to support and improve Australians’ access to medicines.
This funding includes an additional $210 million over three years to community pharmacies and $15 million to pharmaceutical wholesalers in response to lower than forecast prescription volumes and in recognition of the impact of the package of price reduction policies outlined in the Budget measure. As part of the 2017-18 Budget measure, the Government is also providing $600 million in funding to community pharmacy for new and expanded community pharmacy programs delivered under the 6CPA. This funding will enable pharmacies to offer new or expanded services to consumers, including home visits by pharmacists, helping patients with their medication, and supporting Health Care Homes (HCH) with medicine management. The Government undertakes to work collaboratively with the Guild and other key stakeholders to maintain the community pharmacy model and to secure a viable community pharmacy sector that continues to meet the needs of consumers into the future.
The recommendations in the report cover
 2-1: PBS Pricing Variations. 
2-2: The $1 Discount. 
2-3: PBS Safety Net 
2-4: Pharmacy Atlas 
2-5: Consumer Medicines Information. 
2-6: Electronic Prescriptions . 
2-7: Electronic Medications Record 
2-8: Electronic Prescriptions — Consumer Choice 
3-1: Access to Medicines Programs for Indigenous Australians 
3-2: Pharmacy Ownership and Operation by an Aboriginal Health Service 
3-3: Patient Labelling of Medicines under Bulk Supply Arrangements 
3-4: Machine Dispensing 
4-1: Community Pharmacy — Minimum Services 
4-2: Complementary Medicines in Community Pharmacy 
4-3: Placement of Scheduled Medicines within a Community Pharmacy 
4-4: Sale of Homeopathic Products in PBS Approved Pharmacies 
5-1: Community Pharmacy Accounting Information (King  and Watson) and Alternative Recommendation 5-1 (Scott) 
5-2: Remuneration to be based on the Cost of Dispensing Services Associated with a Best Practice Pharmacy Model (King and Watson)  and Alternative Recommendation (Scott) 
5-3: Remuneration for Dispensing – Methodology (King and Watson) and Alternative Recommendation  (Scott) 
5-4: Remuneration Limits 
5-5: Remuneration for Other Services 
6-1: Reforms to Pharmacy Location Rules 
6-2: Pharmacy Location Rules — Concentration of Ownership 
6-3: Transparency in Government Programs . 
6-4: Rural Pharmacy Maintenance Allowance 
6-5: Harmonising Pharmacy Legislation 
6-6: Evaluation Mechanisms 
7-1: Community Service Obligation 
7-2: A Comprehensive Supply Chain Analysis 
7-3: Supporting Access to High-Cost Medicines 
7-4: Supporting Access to Highly Specialised Medicines 
7-5: Tightening the Listing of Generic Medicine 
8-1: Scope of Community Pharmacy Agreements — Dispensing 
8-2: Scope of Community Pharmacy Agreements — Wholesaling 
8-3: Scope of Community Pharmacy Agreements — Programs and Services 
8-4: Community Pharmacy Agreement Participants. 
9-1: Community Pharmacy Programs — Key Principles . 
9-2: Dose Administration Aids — Standards . 
9-3: Home Medicines Review — Removal of Caps 
9-4: Pharmacy Support for Residential Aged Care Facilities 
9-5: Support for Expanded Pharmacy Services Identified by Pharmacy Trial Program 
10-1: Chemotherapy Compounding — Uniform Minimum Standards 
10-2: Chemotherapy Compounding — Payments. 
10-3: Chemotherapy Compounding — Practice Models 
11-1: Managing Patient Medicine Risks on Discharge from Hospitals
In relation to Recommendation 4-4: 'Sale of Homeopathic Products in PBS Approved Pharmacies' the report noted
 Homeopathy and homeopathic products should not be sold in PBS-approved pharmacies. This requirement should be referenced and enforced through relevant policies, standards and guidelines issued by professional pharmacy bodies. 
The Government response is
The Government notes this recommendation. 
The Government notes the importance of the provision of information to consumers for all medicines and health related products available through community pharmacy. 
Professional standards have been designed for use by individual pharmacists to assess their own professional practice. They are intended to serve as guidance for desired standards of practice. However, it is the sole responsibility of the individual pharmacist to determine, in all circumstances, whether a higher standard is required. It is equally their  responsibility to meet that standard and ensure that consumers are provided with the best available information about the current evidence for, or lack-of efficacy in, offered treatments and therapies. 
As in relation to Recommendation 4-2, the Government has accepted the recommendations of the independent RMMDR reforming the regulation of complementary medicines in Australia.
The report's recommendation regarding 4-2 was
Community pharmacists are encouraged to:
a. display complementary medicines for sale in a separate area where customers can easily access a pharmacist for appropriate advice on their selection and use; and 
b. provide appropriate information to consumers on the extent of, or limitations to, the evidence of efficacy of complementary medicines. This could be achieved through the provision of appropriate signage within the pharmacy (in the area in which these products are sold), directing consumers to ‘ask the pharmacist for advice’ if required.
The Government has endorsed a regime where pharmacies - increasingly owned by chains - are free to sell what would be acerbically characterised as snake oil on the basis that a pharmacist is on the premises and thus available to answer any question about whether the pills, potion or salve will work.


The US National Academies study Decrypting the Encryption Debate: A Framework for Decision Makers states
Encryption protects information stored on smartphones, laptops, and other devices—in some cases by default. Encrypted communications are provided by widely used computing devices and services — such as smart-phones, laptops, and messaging applications — that are used by hundreds of millions of users. Individuals, organizations, and governments rely on encryption to counter threats from a wide range of actors, including unsophisticated and sophisticated criminals, foreign intelligence agencies, and repressive governments. Encryption on its own does not solve the challenge of providing effective security for data and systems, but it is an important tool.
At the same time, encryption is relied on by criminals to avoid investigation and prosecution, including criminals who may unknowingly benefit from default settings as well as those who deliberately use encryption. Thus, encryption complicates law enforcement and intelligence investigations. When communications are encrypted “end to end,” intercepted messages cannot be understood. When a smartphone is locked and encrypted, the contents cannot be read if the phone is seized by investigators.
Yet even while the use of encryption is increasing, so is the amount of unencrypted stored data and communications and metadata. This is a result of the growth in the use of smartphones, social networks, text messaging, and other computing and electronic communications over the past decade. The result of the rise in both the amount of data and the use of encryption is that as the amount of data increases rapidly, there is both more data than ever of relevance to investigations and more data than ever that is inaccessible to investigators. With increasing use of encryption, often by default, law enforce- ment and some intelligence officials have increasingly called for a reliable and sufficiently rapid and scalable way to access plaintext—decrypted data and messages—so that they can protect the public and fulfill their public safety and national security missions. In particular, law enforce- ment officials point to
(1) the widespread and increasing use of encryp- tion by default in widely used products and services, 
(2) the myriad national security threats posed by terrorist groups and foreign rivals, (3) the increasing importance of digital evidence as human activity and crime have become increasingly digital, and 
(4) the limited effectiveness of alternative sources of digital evidence.
Critics have objected on a number of legal and practical grounds, arguing that regulations to ensure government access to plaintext likely would
(1) be ineffective, 
(2) pose unacceptable risks to cybersecurity, 
(3) pose unacceptable risks to privacy and civil liberties, 
(4) disadvantage U.S. providers of products and services, and 
(5) hamper innovation in encryption technologies.
In addition, critics argue that mandating means for ensuring government access to plaintext may be less necessary in light of the wider availability of data — and especially metadata —generally, and the alternative means currently available for government officials to obtain access to encrypted data.
There are a wide variety of legal and technical options available to governments that seek access to plaintext for law enforcement and intelligence investigations. These include the following:
• Take no legislative action to regulate the use of encryption, 
• Provide law enforcement with additional resources to access plaintext, 
• Enact legislation that requires that device vendors or service providers provide government access to plaintext without specifying the technical means of doing so, and 
• Enact legislation requiring a particular technical approach.
These are discussed in detail in Chapter 5.
Some computer scientists have reacted with concern to renewed proposals to regulate the use of encryption, citing the security risks. Several attempts have also been made in recent years to develop technical mecha- nisms to provide the government with exceptional access to encrypted data on locked devices and to encrypted communications that would minimize these risks. Three were presented to the Committee on Law Enforcement and Intelligence Access to Plaintext Information during its work (Box 5.1). The committee was not charged with reviewing specific proposals, but it did use these specific proposals to help develop and test its framework for evaluating suggested approaches.
The committee offers a framework (in the form of a set of questions) to ask about any path forward on encryption policy. The objective of this framework is not only to help policymakers determine whether a particular approach is optimal or desirable, but also to help ensure that any approach that policymakers might pursue is implemented in a way that maximizes its effectiveness while minimizing harmful side effects. The questions are as follows:
1. To what extent will the proposed approach be effective in permit- ting law enforcement and/or the intelligence community to access plain-text at or near the scale, timeliness, and reliability that proponents seek? 
2. To what extent will the proposed approach affect the security of the type of data or device to which access would be required, as well as cybersecurity more broadly? 
3. To what extent will the proposed approach affect the privacy, civil liberties, and human rights of targeted individuals and others? 
4. To what extent will the proposed approach affect commerce, economic competitiveness, and innovation? 
5. To what extent will financial costs be imposed by the proposed approach, and who will bear them? 
6. To what extent is the proposed approach consistent with existing law and other government priorities? 
7. To what extent will the international context affect the pro- posed approach, and what will be the impact of the proposed approach internationally? 
8. To what extent will the proposed approach be subject to effective ongoing evaluation and oversight?
In addressing these questions, policymakers will have to contend with incomplete data about the impact of encryption on investigations as well as incomplete data about the deliberate use of encryption by criminals. It is also difficult to quantify key factors such as the additional security risks of adding exceptional access to encryption systems. There are also a number of cases where one can only speculate about future behaviors that have bearing on the implications of government regulation of encryption. These include the fraction of criminals that would use noncompliant, unbreakable encryption if the government were to require vendors to provide exceptional access and the fraction of foreign customers that would eschew U.S. products if exceptional access were required.
Policymakers will also have to contend with the trade-offs associated with encryption and government access that underlie these questions. One of the fundamental trade-offs is that adding an exceptional access capability to encryption schemes necessarily weakens their security to some degree, while the absence of an exceptional access mechanism necessarily hampers government investigations to some degree. How much security is reduced and whether the resulting level of security remains acceptable depend on the specific technical and operational details of the exceptional access mechanism and on the requirements and perspectives of users. The impact on society when an investigation is hindered or thwarted will depend on the scope and scale of the associated crime or national security threat.
There are no easy answers to and many uncertainties in responding to these questions. However, developing and debating answers to these questions will help illuminate the underlying issues and trade-offs and help inform the debate over government access to plaintext.