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The representatives of state authorities (in particular Maksym Nefyodov, Deputy Minister of Economic Development and Trade, and Olexander Starodubtsev, Head of the Department of the Ministry of Economic Development and Trade), real business representatives – pharmaceutical companies, distributors and pharmacy chains, international organizations and professional associations brought together in order to complexly and comprehensively discuss the given issues. Dmytro Aleshko, being a leading expert in the area of state (public) procurements, participated in the profile discussion panel, which opened the conference. The abovementioned Resolution proposes to simplify the state registration procedure for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU.
Novelties in materials expertise for the abovementioned category of medicines and requirements to such materials deserve a special attention.
It is worth to mention that despite the fact that the Resolution has not come into effect yet, the text of this legal regulation published on the CMU web-site should be considered as final.
Upon the consideration of the provided materials the Antimonopoly Committee has come to the conclusion that given marketing agreement does not contain any signs of the abuse of monopoly and anticompetitive concerted actions conducted by GlaxoSmithKline Ukraine. Moreover, the project team put major efforts into the materials preparation aimed at the justification of Competition Law non-infringement by the drafted marketing agreement concluded with the pharmacies and pharmacy chains. The document proposes to extend the list of medicinal products liable for simplified state registration, in particular to simplify the procedure for those medicinal products that have already been registered by the competent authorities of the USA, Switzerland, Japan, Australia, Canada or the European Union. The Parliament Health Care Committee did not support this Draft Law and submitted it for further improvement. The Regulation proposes to establish the selection procedures (development of the first draft Essential Medicines List by the Expert Committee) and yearly revision of the National Essential Medicines List. Further, upon the approval of the first Draft National Essential Medicines List the Expert Committee shall revise the existing taking into account the abovementioned factors and sources. The Draft Regulation also established the schedule of revision of the National Essential Medicines List.
Please note that the Order of the Ministry of Health of Ukraine as of February 11, 2016, a„– 84 approved the Regulation on the National Essential Medicines List and the Regulation on the Expert Committee on the selection and usage of essential medicinal products.
For 28 years, The Legal 500 has been analyzing the capabilities of law firms across the world, with a comprehensive research programme revised and updated every year to bring the most up-to-date vision of the global legal market. The Concept suggests the implementation of activities aimed at solving the issues of timely patients support with qualitative, safe and efficient medicinal products, immunobiological products and medical evices, and activities aimed at the prevention of corruption and limited competition that lead to medicinal products and medical devices procurement at an over-inflated price. The document authors note that the Concept designates the directions, mechanisms and terms for public procurements system transformation in healthcare sector of Ukraine through the development of modern convenient system aimed at the establishment of competitive environment and further development of fair competition in this sector. The Concept shall be implemented with the assistance of international organizations and donors in three stages during 2016—2018. Stage 1 (2016) – establishment of institutional and legal basis for the reformation of public procurements in healthcare sector. CPO shall fulfill the procurements at local and foreign levels, and if required shall maintain the procurement from international suppliers — import of medicinal products, immunobiological products and medical devices, involve other organizations into customs clearance, storage and distribution, conduct other business activities based on long-term plan principles. The procedure for insulin products reimbursement foresees that the pharmacy warehouse should file monthly report on the medicinal products sold. Moreover, the document amends the CMU Resolution as of March 5, 2014, a„– 73 "On the Implementation of Pilot Project on State Regulation of Insulin Products Prices" regarding the definition of the unified mechanism of the state regulation of insulin products prices. These medical devices are allowed for market distribution before their expiry date and not later than 5 years from the date of their sales start without the compliance assessment and national quality standard mark. Based on the abovementioned, the compliance assessment procedures shall become obligatory starting from July 1, 2017 for registered medical devices with the unlimited state registration certificate or with the certificate expiring after this date.
Another significant change introduces the opportunities to conduct the compliance assessment procedures during the period of validity of medical devices registration certificate. Moreover, certain changes have been introduced into the registration of the officials responsible for putting medical devices into operation.
In case such entity is not a resident of Ukraine, the authorized representative should be assigned with the responsibility to introduce such medical devices into Ukrainian market. State Administration of Ukraine on Medicinal Products should maintain a Register of entities responsible for the introduction of medical devices into the market. The legal support of the development and adoption of the abovementioned Order of Cabinet of Ministers, as well as the above-mentioned order of the Ministry of Health of Ukraine was provided by the Legal Alliance Company in cooperation with the SIAPS project.
The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards  in terms of health and level of funding for health care. The Expert Committee will consist of 12-18 people, it will be composed of specialists with higher medical, pharmaceutical and economic education. Once an expert committee under the Ministry of Health of Ukraine is established, work concerning the selection of drugs to be included in the National List will be conducted by them. Interested individuals and legal entities can apply with a package of necessary documents  for inclusion of drugs in the National List of Medicines. Notice of tax assessment is developed for each separate tax due together with the penalties, as well as for each penalty and poena for the violation of other legislation being under supervision of regulatory authorities. Notice of tax assessment is considered to be submitted to the taxpayer – legal entity if such assessment notice is delivered by hand to the official employee of such taxpayer against acknowledgement or forwarded in a letter with notification of the delivery.
Notice of tax assessment is considered to be submitted to the taxpayer – individual if such assessment notice is delivered by hand to such individual or his authorized representative or forwarded in a letter with notification of the delivery to the address of residence or of the latest known location of such individual. The new Law provides for the implementation of public procurement with the use of two competitive regulatory procedures: open tendering and competitive dialogue, as well as a non-competitive procedure - negotiating the purchase procedure.
An important innovation of the Law is the introduction of electronic procurement (e-auction), the electronic review system, as well as the implementation of the exchange of information, documents, to provide clarifications in the e-procurement system.
Moreover, for the conduct of unauthorized concentration, which did not lead to monopolization and significant impediment of competition on Ukrainian market , the AMCU recommends to calculate the basic penalty in accordance with the total revenue (income) received from the sales of products (goods, services) at all commodity markets of Ukraine. The AMCU made the greatest specification regarding the calculation of the basic penalties in the cases of the infringements of informational character. Moreover, the AMCU believes that if the incorrect information has been provided several times during the consideration of the case regarding the violation of informational character, the total penalty charges shall amount to the penalty for one relevant violation. It is worth to mention that the AMCU established the reduced penalty, which may be imposed on the respondent during the investigation of the case of informational character and on the applicant in the case regarding the concentration and the concurrent actions if they provided incomplete case information.
Correction of previously determined penalty taking into consideration the aggravating and mitigating circumstances. Declarations with violation of the deadlines for submission for the reporting period in case the application is submitted within its contents.
The registers are published at the official State Fiscal Service’s web-site on a daily basis. In case the Main Directorates of the State Fiscal Service in regions, or in the city of Kyiv send to the appellant the decision on final or partial denial of the appeal, the appellant has a right to file the subsequent appeal within 10 calendar days upon the receipt of such decision. The document in its new edition, updated and improved in line with the requirements of the Law of Ukraine "On Prevention of Corruption", was recently approved by the  Management Board of AIPM Ukraine.
The project was conducted by Oleksii Bezhevets, partner with Legal Alliance Company and senior associate Lidiya Sangarovskaya-Gurlach. The most important among the suggested amendments is the one concerning the Procedure of monitoring of adverse reactions to medicinal products permitted for medical use as approved by decree a„– 898 of the Ministry of Health of Ukraine, dating December 27, 2006 (hereinafter - the current procedure), in the new edition, changing its name to "The Procedure for the Conduct of Pharmacovigilance" (hereinafter - the new procedure). Thus, the new procedure determines that the applicant may have more than one system of pharmacovigilance, for example, specific systems for different types of medicines (vaccines, OTC drugs, etc.). With regards to the authorized person, the new order establishes that in the case of the applicant, who is located in Ukraine, the authorized person must be part of the applicant's personnel. The new procedure defines the document with a detailed description of the pharmacovigilance system as a Pharmacovigilance System Master File (PSMF). An important achievement of the new procedure is to establish the requirements for the system of risk management in pharmacovigilance. In contrast to the existing rules, the new procedure provides for the obligation of creating a risk management plan. In concern with medicinal products that do not require the creation of risk management plans, the applicant must support the specification file of important identified risks and important potential risks with the aim of preparing regular reports.
In terms of other amendments foreseen by the new procedure, emphasis should be given to the advanced categorical apparatus and a new player in the field of pharmacovigilance - rapid response groups of relevant departments of Health, which are responsible for investigating all serious adverse events after immunization and some others.
Therefore, the adoption of the new order will contribute to the harmonization of national legislation with the European legislation.in the field of pharmacovigilance. It is to be recalled that  in their time some of the provisions were "the bone of contention" between the regulator and the subjects of the pharmaceutical market. Therefore a situation may arise where the abovementioned provisions will be in force before the relevant decision of the Cabinet of Ministers' of Ukraine albeit with the edition of order a„– 143. The abovementioned draft legislation proposes the disclosure of information contained in the materials of the pre clinical studies and the clinical trials that are attached to the application for the registration of the medicinal product.
In the opinion of the legislation draft's initiators, the closed nature of such data results in the circulation of drugs, whose effectiveness and safety have not been proved.
The Project aims to supporting of Ukrainian government in issue of improvement of effectiveness and transparence in public purchasing system for medicinal products, in particular, by complying of National list of main medicinal products and medical devices with international standards. This year the event attended 130 representatives of the pharmaceutical sector, specialized media, non-governmental organizations, professional associations, and state regulatory authorities. In the beginning of the session Dmytro Aleshko presented a report on the regulation of the medicinal products and medical devices market. Taking into consideration the composition of the event members many of whom represented the medical devices market, the regulation of the medical devices circulation in 2016 was discussed during a separate interactive session involving Pavel Harchyk, President of the Association of market operators of medical devices, Natalia Serhienko, Health Care Committee Executive Director, European Business Association, and Darya Bondarenko, CEO of Association of market operators of medical devices.
The next session of the conference touched the most current issues of the organization of corporative ethics and anticorruption compliance system in the pharmaceutical business. Following the traditions of the summery conferences the session on taxation of pharmbusiness was held. The highly topical conference programme did not let the participants to relax and loose focus, just as the regulatory and law-enforcement authorities does not let the sector representatives to relax in the course of the year. Hygiene requirements  exclusively concern dietary suppements and do not apply to medicinal products, functional foods and special dietary foods.
Hygienic requirements set requirements for the content of dietary supplements, in particular, the latter indicate that for the production of dietary supplements  vitamins and minerals listed in Annex 1 of the hygiene requirements may be used, in the form specified in Annex 2 to the hygienic requirements. Therefore  amendments are provided to the Law of Ukraine "On Insurance" , namely by defining sponsor liability insurance a mandatory type of insurance .
The document designates the mechanism for taxpayers’ appeals against tax assessment notices or any other decisions made by the regulatory authorities in the course of administrative procedure. This Procedure shall not be applied to the appeals against the regulatory authorities’ decisions, actions or inactions of their officers or other employees if the special law establishes other procedures for appeals. Complaints about the decisions of state tax inspection offices are filed to regulatory authorities in Kyiv and regions, to inter-regional territorial agencies. Complaints about the decisions of regulatory authorities of Kyiv and regions, of inter-regional territorial agencies, and of customs offices are submitted to the State Fiscal Service of Ukraine. The decisions of State Fiscal Service of Ukraine made upon the consideration of taxpayers’ complaints are final and without any further administrative appeal, however may be appealed to court. The complaint should be submitted in writing to the higher regulatory authority within 10 calendar days following the taxpayer’s receipt of the respective decision made by the regulatory authority. The complaints for the regulatory authorities’ decisions and actions should be cited and submitted separately. The taxpayers may attach to their complaints all calculations and evidence, which they deem appropriate.
Certified copies of quality certificates (certificates of analysis, test reports, etc.) issued by the manufacturer for the series of medicinal products to be imported. The Ministry of Health shall within five working days from documents delivery shall issue for the importer a certificate of import confirmation or send a written refusal notice indicating the reasons for refusal. The Ministry of Health shall issue within five working days from documents delivery the certificate of confirmation for the medicines payment under the agreements or send a written refusal notice indicating the reasons for refusal.
The supplier shall submit the confirmation certificate to the revenues and duties authority, where it is registered as a tax payer, not later than 10 working days after the deadline for submission of VAT declaration for the relevant reporting (tax) period.
The intended use of the medicinal products and medical devices exempt from VAT shall be fulfilled in accordance with corresponding legislation. Nevertheless, the tax payers are still obliged to pay advanced corporate profit tax payments for the first three quarters of 2016.
The failure to make this payment shall result in imposing on such tax payer the penalty in the amount provided in Article 123 of the Tax Code of Ukraine.
Galexia directors Chris Connolly and Peter van Dijk are the authors of a chapter in the new book Enforcing Privacy - Regulatory, Legal and Technical Approaches (published by Springer, April 2016). Chris Connolly and Peter van Dijk contributed the chapter on Enforcement and Reform of the EU-US Safe Harbor Agreement. Galexia advises on options for the cross border transfer of personal data in compliance with global, regional and national data protection requirements.
Our latest research report has been released - The 2016 BSA Global Cloud Computing Scorecard (a joint research effort with Galexia) ranks the cloud computing readiness of 24 countries that account for 80 percent of the world s IT markets.
Our latest research report has been released - The 2016 BSA Global Cloud Computing Scorecard (a joint research effort with Galexia) ranks the cloud computing readiness of 24 countries that account for 80 percent of the world’s IT markets.
The 2016 BSA Global Cloud Computing Scorecard ranks the cloud computing readiness of 24 countries that account for 80 percent of the world’s IT markets. In terms of overall ranking, the biggest improvers were South Africa (moving up six places) and Canada (moving up five places). The BSA Global Cloud Scorecard analyzes the legal and regulatory framework and broadband infrastructure of 24 countries that together make up 80 percent of the global ICT market. The study includes a detailed country-by-country analysis of legislation, regulations, case law, government policy and standards. The study includes detailed country-by-country analysis of legislation, regulations, case law, government policy and standards. Galexia director Chris Connolly will be assisting in the presentation of a two day expert meeting on Data Protection and Privacy: Implications for Trade and Development on 19-20 April in Geneva. A highlight of the E-Commerce Week is the Ad Hoc Expert Meeting on Data Protection and Privacy: Implications for Trade and Development (19-20 April).
This ad hoc expert meeting will contribute to ensure global communication on the subject to understand emerging topics in data protection and privacy, new challenges and opportunities, as it relates to unlocking the potential for cross-border trade.
The Ad Hoc expert meeting will commence with the presentation of the UNCTAD Study on Data Protection and International Data Flows. Galexia has published an article on the proposed EU-US Privacy Shield, which is set to replace the former Safe Harbor as the key mechanism for the transfer of personal data from the European Union to the United States. The draft Privacy Shield adequacy decision by the European Commission is yet to be formalised - the commission must first seek the opinion of the influential Article 29 Working party.
The former Safe Harbor framework was the subject of extensive research and analysis by Galexia, including a major report in 2008 followed by ongoing monitoring and the submission of evidence and reports to the EU and US authorities. The European Union Network and Information Security Directive (the NIS Directive) has moved a step closer to implementation after the EU's Internal Market Committee voted to support the Directive on 16 January 2016.
The European Union Network and Information Security Directive (the NIS Directive) has moved a step closer to implementation after the EU's Internal Market Committee voted to support the Directive on 16 January 2016. Galexia has been at the forefront of studying the potential impact of the NIS Directive, both in Europe and beyond. The subsequent Asia Pacific CyberSecurity Maturity Dashboard (including 10 country reports and case studies considers the maturity of APAC countries through the lens of the NIS directive.
Galexia Director Chris Connolly will deliver a special presentation at the Privacy Laws and Business Conference at Cambridge University on July 7.
The presentation will mark the fifteenth anniversary of the launch of the EU-US Safe Harbor, and is titled: 'The Safe Harbor at Fifteen' - A brief history of enforcement and reform.
The presentation will be followed by a panel discussion including Commissioner Julie Brill (US Federal Trade Commission) and Bruno Gencarelli (Head of Data Protection at the European Commission Directorate General for Justice).
The report assesses each country against criteria deemed essential for effective cybersecurity protection. The full country reports are available for download and give an overview of the cybersecurity landscape, highlighting key cybersecurity legislation and policy, as well as the main entities currently operating within each jurisdiction. It is with great sadness that we report the loss of Galexia Associate and close friend Claro Parlade, who has died in the Philippines after a period of illness. Claro was a well known IT lawyer in the Philippines who played a key role in the development of cyberlaws in the Asia Pacific region. In June 2015 Galexia completed a Privacy Review of the National Diabetes Services Scheme (NDSS) for Diabetes Australia. The Report evaluates national laws, rules and policies in all 28 EU Member States against 25 criteria deemed essential for effective cybersecurity protections. The full Member State reports give an overview of the cybersecurity landscape, based on the set of criteria outlined below, highlighting key cybersecurity legislation and policy, as well as the main entities currently operating within each jurisdiction. This work complements Galexia’s other research reports for BSA, including the soon to be Global Cloud Readiness Scorecard published in 2012, 2013 and in April 2015. Galexia Director Chris Connolly will present a paper on Global Issues in Cybersecurity and Privacy in Geneva on 25 March 2015. The Expert Meeting on Cyberlaws and Regulations for Enhancing E-Commerce has been organised by the United Nations Conference on Trade and Development (UNCTAD). The session will explore recent developments related to e-commerce in respect of data breaches and fraud.


Galexia has a long history of working with UNCTAD (and ASEAN and other regional groupings) on international cyberlaw issues.
In August 2014 Galexia began work on an important research project for BSA - The Software Alliance. The study will include a detailed country-by-country analysis of legislation, regulations, case law, government policy and standards. Galexia conducted a Privacy Impact Assessment (PIA) for the Victorian Department of State Development, Business Innovation (DSDBI) on the proposed migration of the Resource Rights Allocation and Management (RRAM) Project to a commercial cloud provider.
Galexia conducted a Privacy Impact Assessment (PIA) for the Victorian Department of State Development, Business & Innovation (DSDBI) on the proposed migration of the Resource Rights Allocation and Management (RRAM) Project to a commercial cloud provider.
Galexia has particular experience in advising Government agencies in their successful migration to cloud and externally hosted services.
In July 2014 Galexia began work on an important research project for BSA - The Software Alliance. The countries included in the study are Australia, China, India, Indonesia, Japan, Korea, Malaysia, Singapore, Thailand and Vietnam. This work complements our earlier research reports for BSA, including the Global Cloud Readiness Scorecard published in 2012 and 2013.
The new report will include a detailed country-by-country analysis of legislation, regulations, government policy, standards and infrastructure related to Cybersecurity.
Galexia has been appointed to the Department of Communications Technology Advice Panel to provide specialised services to the Department. In June 2014 Galexia began work on an important research project for BSA - The Software Alliance.
Galexia Director Chris Connolly presented a paper on The Future of the EU-US Safe Harbor at a major privacy research conference in Brussels on 1 June 2014. The presentation focused on enforcement issues, and follows previous Galexia research on compliance issues in the EU-US Safe Harbor. Galexia completed a Privacy Impact Assessment (PIA) for the Victorian Department of State Development, Business Innovation (DSDBI) on the migration of Business Victoria Online (BVO) services to a commercial cloud services provider.
Galexia completed a Privacy Impact Assessment (PIA) for the Victorian Department of State Development, Business & Innovation (DSDBI) on the migration of Business Victoria Online (BVO) services to a commercial cloud services provider. Galexia provided a range of cloud and privacy advice and developed a re-usable template and checklist driven approach for future PIAs. In early 2014 Galexia completed a Privacy Impact Assessment (PIA) for proposed changes to the customer due diligence requirements of Australia s Anti-Money Laundering and Counter-Terrorism Financing Framework (the CDD project). In early 2014 Galexia completed a Privacy Impact Assessment (PIA) for proposed changes to the customer due diligence requirements of Australia’s Anti-Money Laundering and Counter-Terrorism Financing Framework (the CDD project). The PIA was one of the first PIAs conducted in accordance with the new Australian Privacy Principles (APPs) that came into force in March 2014.
Galexia was able to advise AUSTRAC on how to incorporate important changes to customer due diligence requirements that form part of international commitments to tackle money laundering, while complying with Australia's revised privacy legislation. Galexia Director Chris Connolly appeared at the House of Lords EU Sub-Committee on Home Affairs, Health and Education in London on 12 March 2014. The Committee was investigating the potential reform of the EU US Safe Harbor Framework which allows some EU personal data to be transferred to the United States. On 7 May 2014 the Committee issued a final report, calling for improvements to the Safe Harbor. Galexia Director Chris Connolly appeared at the Commonwealth Cybersecurity Forum in London on 5 March 2014.
Galexia has played a key role in assessing national, regional and global approaches to cloud computing privacy and security policies. In October 2013 Galexia and Doll Martin Associates strengthened their existing partnership and announced a closer strategic alliance. In October 2013 Galexia and Doll Martin Associates strengthened their existing partnership and announced a closer strategic alliance. The Committee on Civil Liberties, Justice and Home Affairs (the LIBE Committee) is holding an inquiry on electronic mass surveillance of EU citizens, and Chris will appear before the Committee in Strasbourg on Monday October 7.
Galexia and the United Nations Conference on Trade and Development (UNCTAD) have released a major report, entitled Review of E-commerce Legislation Harmonization in the Association of Southeast Asian Nations (2013). Galexia and the United Nations Conference on Trade and Development (UNCTAD) have released a major report, entitled Review of E-commerce Legislation Harmonization in the Association of Southeast Asian Nations (2013). This 2013 review documents the significant advances made by ASEAN countries in the area of e-commerce laws. Galexia’s extensive and detailed work with ASEAN has assisted ASEAN be the first region in the developing world to adopt a harmonized legal framework for e-commerce and it is the most advanced developing region in terms of implementing harmonized e-commerce laws.
The review includes detailed regional and national analysis of e-commerce laws, privacy, cybercrime and cloud computing. Galexia provided the Australian Energy Market Operator (AEMO) with options for implementing Single Sign-On (SSO) to external Software-as-a-Service (SaaS) applications. Galexia was engaged to undertake an independent review on the operations and effectiveness of the Queensland Personal Identification Information in Property Data (PIIPD) Code. Galexia has played an ongoing role in the development, implementation and review of a code-of-conduct for QVAS (Queensland Valuation and Sales System).
This code-of-conduct is an excellent example of successful privacy self-regulation in the information broking sector. The 2013 Global Cloud Computing Scorecard the first-ever report to track year-over-year change in the international policy landscape for cloud computing shows that cloud readiness is improving, if unevenly.
These findings come against the backdrop of the massive and well-documented movement to cloud services by consumers, businesses, and governments. Countries around the world are improving the legal environment for cloud computing — though at an uneven pace that risks undermining the full economic potential of cloud technologies.
The new 2013 BSA Cloud Scorecard builds on an inaugural edition of the report released last year. The study finds that policy improvements in many of the world’s biggest IT markets have stalled. The study evaluates countries in seven policy areas critical to the market for cloud computing services — data privacy, cybersecurity, cybercrime, intellectual property, technology interoperability and legal harmonization, free trade, and ICT infrastructure. Malaysia crossed the divide between mature and developing economies by bolstering cybercrime and IP laws and opening itself for increased digital trade. Canada, Russia, and India all moved up the rankings by implementing international IP agreements.
Indonesia and Vietnam are among the countries tying up foreign cloud providers in red tape, imposing data-location requirements, or restricting the flow of data across borders. The 2nd Cloud Readiness Index (CRI) developed by the Asia Cloud Computing Association evaluates key attributes in order to identify the state of readiness for cloud computing in 14 markets across the Asia region. The Index is designed to look at the state of readiness for cloud computing in markets across the Asia Pacific region - especially how we see regulation and policy work by governments - to help advance cloud computing in Asia.
The Index incorporates information from several sources, including the Global Cloud Computing Scorecard (2012) completed by Galexia for the Business Software Alliance (BSA) in February 2012. On 22 February 2012, the Business Software Alliance (BSA) launched the BSA Global Cloud Computing Readiness Scorecard (2012) developed by Galexia.
The first-of-its-kind Scorecard analyses and ranks the legal and regulatory framework and broadband infrastructure of 24 countries based on seven policy categories that measure the countries’ preparedness to support the growth of cloud computing. The Scorecard also includes a detailed country-by-country analysis of legislation, regulations, case law, government policy and standards.
On 14 February 2012 Galexia presented the new Global Cloud Readiness Scorecard at the Cloud Connect conference in Santa Clara USA. In September 2011 the Australian Securities and Investments Commission (ASIC) issued a completely revised and updated Code of Conduct for Electronic Transactions.
In September 2011 the Australian Securities and Investments Commission (ASIC) issued a completely revised and updated Code of Conduct for Electronic Transactions. Galexia Director Chris Connolly was a member of the expert working group revising the Code - a process that took two years to complete and involved three rounds of public consultation. Galexia assisted CHOICE with its submission regarding the 2007 review of the Electronic Funds Transfer (EFT) Code of Conduct, as conducted by the Australian Securities and Investment Commission (ASIC). The paper recommends the introduction of private sector privacy legislation based on a mix of EU and APEC best practice. Singapore joins a growing list of countries with proposed and draft privacy legislation in the region.
The Cloud Readiness Index developed by the Asia Cloud Computing Association evaluates key attributes in order to identify the state of readiness for cloud computing in 14 markets across the Asia region.
The index incorporates information from several sources, including the Asia Pacific Digital Economy and Cloud Computing Scorecard completed by Galexia for the Business Software Alliance (BSA) in March 2011. Galexia director Chris Connolly is the joint author of two articles on privacy and health data.
Regulation and Perception Concerning the Use of Health Data for Research in Australia, Christine M O'Keefe and Chris Connolly was published in the Electronic Journal of Health Informatics, Vol 6, No 2 (2011): Special Issue on Smart Healthcare Systems. The primary objective of this review is to provide an overview of the issues involved in balancing privacy and access in the context of health research. The topic of our review is of current interest in the context of the Australian Government National Collaborative Research Infrastructure Strategy (NCRIS) investment in the Population Health Research Network (PHRN), which aims to provide improved accessibility to health-related data for the research sector.
Although there is little evidence of privacy complaints or breaches in health research, it seems clear that privacy regulation and privacy perception are both key factors in the health research context, acting as potential restraints on some types of research that could deliver considerable public benefit. Recent Australian Law Reform Commission recommendations leave room for technical solutions to play an increased role in allowing personal information to be de-identified for research purposes. An Overview of International CyberSecurity Awareness Raising and Educational Initiatives - a report for the Australian Communications and Media Authority (ACMA) by Galexia in partnership with the Cyberspace Law and Policy Centre, was launched in CyberSecurity Awareness week - 30 May 2011. The study included research and advice on 68 Cybersecurity initiatives (both government and private sector) in 11 jurisdictions. Galexia Director Peter van Dijk and Galexia s Singapore based Associate Yee Fen Lim presented the Asia Pacific Digital Economy and Cloud Computing Scorecard at an industry workshop in Hong Kong in April 2011.
Galexia Director Peter van Dijk and Galexia’s Singapore based Associate Yee Fen Lim presented the Asia Pacific Digital Economy and Cloud Computing Scorecard at an industry workshop in Hong Kong in April 2011. The Scorecard is a comparative analysis of major cyberlaw issues and digital infrastructure in 14 Asia-pacific countries. The workshop was attended by industry associations and business leaders from countries in the region, with strong representation from both developed and emerging economies.
Galexia has completed a comprehensive review of digital economy laws and infrastructure in 14 Asia Pacific countries - the Asia Pacific Digital Economy and Cloud Computing Scorecard.
The 14 countries in the study are: Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand and Vietnam. The Joint Standing Committee on Treaties has recommended that Australia accede to two important cyberlaw Conventions.
The United Nations Convention on the Use of Electronic Communications in International Contracts (the Convention) is the first United Nations Convention to address legal issues arising from the digital economy. The Convention contains a comprehensive framework for establishing contracts using electronic communications. The Committee noted that in practice, businesses with disputes relating to electronic contracts have not sought to use legal means to resolve their disputes. The Committee recommended that Australia take binding treaty action to join the United Nations Convention on the Use of Electronic Communications in International Contracts. Over 30 European member states and one non-member, the United States, are party to the Convention. The Treaties Committee drew considerable attention the role of the Convention in boosting international co-operation to deal with increasingly sophisticated and diverse forms of computer-related criminal activity. Establishment of a 24 hour, 7 days per week point of contact to receive requests and provide assistance for searching and accessing computer data.
Naturally, these aspects of the Convention have raised some community concerns about privacy and security.
The Attorney-General’s Department submitted to the Treaties Committee that the capacity to access and preserve data is fundamental to the new mutual assistance arrangements. The Committee recommended that Australia should accede to the Council of Europe Convention on Cybercrime and update local laws as appropriate. Galexia provided detailed advice to the Victorian Department of Innovation, Industry and Regional Development (DIIRD) on cloud computing. In 2009 Galexia prepared an assessment for the Victorian Department of Innovation, Industry and Regional Development (DIIRD) on issues associated with cloud computing and issues concerning potential outsourcing and off-shoring of data. The research for the report was a joint effort between Galexia and the Cyberspace Law and Policy Centre.
Galexia Director, Chris Connolly, presented at the Privacy Laws Business 23rd Annual International Conference in Cambridge, UK, from 5-7 July 2010.
Galexia Director, Chris Connolly, presented at the Privacy Laws & Business 23rd Annual International Conference in Cambridge, UK, from 5-7 July 2010.
Galexia has previously conducted research into trustmark schemes and the Safe Harbor privacy framework. Malaysia’s lower house (Dewan Rakyat) has passed the Personal Data Protection Act 2009. Galexia and Qubit Consulting have implemented a major new identity management solution for the University of Western Sydney.
Galexia and Qubit Consulting have conducted a major upgrade of identity systems for the University of Sydney. On behalf of ACCAN, Galexia prepared a submission to the Expert Panel On Franchising And Unconscionable Conduct, established by the Government following a parliamentary inquiry into provisions of the Trade Practices Act 1974 that prohibit unconscionable conduct.
The submission proposes to reform Australia’s consumer laws by inserting a new fairness test into Section 52 of the Trade Practices Act (and all legislation that mirrors that test).
Galexia Director, Chris Connolly spoke at Privacy in the Asia-Pacific: 2010 Update A comprehensive survey of privacy and data protection in the region on 2 March 2010.
Thus, the term for materials expertise conducted by the State Expert Center has been reduced to 20 business days. The Resolution proposes the Ministry of Health to establish the expertise procedures for the abovementioned products, but with an approval of the Ministry of Economic Development.
This Draft Law also proposes to establish the simplified registration procedures for all medicinal products that have already been registered in the USA, Switzerland, Japan, Australia, Canada, and the EU. In particular, the team made a comprehensive research on medicinal product markets, which may be affected by the concluded marketing agreement, conducted social and marketing studies, analyzed the experience of GlaxoSmithKline group of companies regarding the relevant agreements in other countries, developed internal standard operating procedures for the Client with regard to pharmacies and pharmacy chains cooperation. We would also like to express our gratitude to the project team members representing GlaxoSmithKline Ukraine for the fruitful collaboration. The Draft Law was initiated by the Cabinet of Ministers of Ukraine and presented the same say at the Government session. This Regulation belongs to the package of documents drafted in order to implement the new model of Essential Medicines List.
The difference lies in the fact that all individuals intending to include a particular medicinal product into the List shall have an opportunity to submit a corresponding application including the documents confirming the comparative efficiency, safety and cost-effectiveness of the product.
The Regulation Annexes formalize the application execution Instruction for amending the National Essential Medicines List.
The adoption of the Draft Resolution shall promote the establishment of professional centralized procurement organizations (hereinafter - CPO) in Ukraine, which requires some time and incremental actions. CPOs shall be established under the Health Ministry decision and shall operate under its supervision.
During this period all medical devices shall be introduces to the market and put into operation on the basis of acting certificate of state registration. Registered medical devices with the certificate expiring after July 1, 2017, should undergo the compliance assessment procedures after the expiration of such certificate in order to stay on the market. The structure and contents of national lists will be based on the latest edition of the Basic List of Essential Medicines recommended by WHO. An important step forward is the need to study whether or not such persons present a conflict of interest, as well as the possibility of participation of foreign specialists with the necessary knowledge and experience in the selection process in the national list,"- said Dmytro Aleshko, who heads the team of experts developing a normative - regulatory package  on this matter. Such persons shall not present a real conflict of interest, in particular,  they should not be in an employment or any other contractual relationships with producers and holders of certificates of registration of drugs or associated persons. At the same time, the Law provides a number of cases to which the provisions of the latter do not apply.
In addition, the AMCU has specified the meaning of such aggravating circumstances as the obstruction of case investigation. This method is recommended in case the respondent did not provide any information on the total revenue at the market where the concentration took place and at adjacent markets. Thus, previously the basic penalty equaled up to 5% of the revenue from the sales of the products (goods, works, services) of economic entity in the last reporting year prior to the year the penalty was charged, and if there was no revenue or the respondent did not provide any information on the total revenue – the penalty equaled to 10 000 of non-taxable incomes of the residents.
The written appeal should contain all data outlined in the Procedure, it should be signed by the appellant-physical entity or by the authorized person, for other appellants – the appeal should be signed by the director or a legally authorized representative and sealed (if available).


Thus, the new procedure provides a number of new features, the most interesting of which relate to the applicant.
At the same time, each applicant's pharmacovigilance system can have only one authorized person responsible for the pharmacovigilance (hereinafter – authorized person).
Should the applicant not be located in Ukraine, then a contact person for pharmacovigilance in Ukraine, who is a subordinate of the applicant's authorized person, must be assigned on the territory of Ukraine. In comparison with the current procedure, the new procedure establishes simultaneously a clear framework for such PSMFs with the requirements for information that must be contained in it.
It should be noted that the current procedure contains a provision, according to which the applicant creates a pharmacovigilance risk management plan, i.e.
The draft resolution prepared by the Ministry of Health of Ukraine , does not contain any significant differences , except for some editorial amendments. The matter concerns a three-way contract, the requirement for the conclusion of which seems by importers to not be feasible. Therefore the draft legislation at hand is aimed at initiating access to such information, which will enable all interested citizens, their associations and professionals to decide on the selection  for the appointment and the medical use of the medicinal products on the basis of objective data concerning the level of proof on their safety and effectiveness. Being an annual event for the pharmaceutical sector representatives, the Conference focuses on the regulatory aspects of the pharmbusiness and other legal tendencies of the pharmaceutical market.
Krzysztof Siedlecki, European Business Association President, Astellas Pharma Europe BV Country Manager Ukraine, Dr. The discussion was held around the current status, potential problems and roadmaps in this sphere. The session was opened by Legal Alliance Partner Oleksii Bezhevets, who informed the participants on the main changes in anticorruption requirements. Legal Alliance Associate Partner Andrii Gorbatenko, who leads the antimonopoly and competition law practice, acted as a moderator of this session.
Nevertheless, all the attendees remained satisfied with a quantity and quality of the information received at the event and expressed a desire to meet in such a format at least twice a year. Quality criteria for nutrients used for the production of dietary supplements must comply with the requirements of Ukrainian legislation and in their absence - standards established by the Codex Alimentarius Commission. The opportunity to track  dietary supplements and any substance intended to be administered in dietary supplements should be ensured at all stages of production and circulation. According to the proposed changes , the relevant contract may be concluded not only by the sponsor of the clinical trial , but also by their  authorized representative.
In addition the mentioned procedures shall not be applied to the appeals against decisions made in the course of administrative violations proceedings.
This is the first major book to focus on the enforcement of privacy, and contains chapters from many leading privacy experts, including key regulators, academics, consultants and politicians. The enforcement of these arrangements is a key issue in data protection, and this book provides a unique insight into the diversity of legal and technical enforcement options that are in use today.
But the stratification between high-, middle- and lower-achieving country groups has widened, with the middle-ranking countries stagnating even as the high achievers continue to refine their policy environments..
These services in return open the door to unprecedented connectivity, productivity and competitiveness. For example, few countries are promoting policies of free trade or harmonization of cloud computing policies.
The analysis is grouped under seven policy categories that are central to the growth and operation of cloud computing. The assessments include an evaluation of enforcement and implementation of existing laws in each country, as well as an assessment of compliance with relevant treaties and global agreements where applicable. The week includes sessions on cybercrime readiness, consumer protection online, ICT policy reviews and the proposed Action Plan for Aid for eTrade. Recent and expected regulatory changes in the field of data protection and privacy as well as diverging approaches in different parts of the world, call for renewed discussion on possible ways forward. Industry players and consumers, as well as governments and international organizations will present their perspectives and outline the latest developments, current practices and relevant frameworks.
Representatives from public and private stakeholders will then take the floor to discuss thematic topics and present their experiences. However, it is almost certain that the Privacy Shield will be implemented in some form in the near future. This was the final major hurdle in the passage of the Directive, and the Directive is expected to be endorsed by parliament in the near future.
One of our key reports on CyberSecurity is the 2015 EU CyberSecurity Maturity Dashboard (including 28 Country reports and case studies). Claro collaborated with Galexia on several regional projects, and was based in the Galexia offices in Sydney for a short period while he worked on the development of the Philippines privacy legislation, (the Data Privacy Act 2012). He was a global expert, having lived, worked and studied in the Philippines, Australia, Canada, the US and Singapore. Claro’s gentle combination of wit, insight, friendship, intellect and cyber-law expertise will be missed by all of us. It is intended to provide EU Member States with an opportunity to evaluate their countries’ policies against key metrics and maps a way forward by outlining the key building blocks for a strong cybersecurity legal framework. It will discuss ways to ensure confidence and trust in the use of the Internet through the enactment of legal and regulatory frameworks for protecting personal data, privacy and combatting cybercrime.
Galexia has been commissioned to prepare the 3rd Global Cloud Computing Readiness Scorecard, following the success of the 2012 and 2013 scorecards. We have assisted in the development of a staged privacy and security assessments and compliance framework for prior migrations.
Galexia has been commissioned to prepare a report on Cybersecurity in 10 Asia Pacific nations. Galexia has been commissioned to prepare a report on Cybersecurity in 28 European Union nations. The Safe Harbor Framework is a mechanism for allowing some EU data to be transferred to US businesses while protecting the privacy of individuals. Mr Connolly was asked to provide evidence on the level of privacy protection provided under the Framework. He discussed the balance between privacy and security in the emerging cloud computing environment.
Galexia and Doll Martin Associates have worked on projects together since 2005 and both organisations have decided to leverage their particular strengths and synergies by working together. Chris's task will be to comment on the effectiveness of the US Safe Harbor Privacy Framework, a topic that Galexia has covered in several previous research papers, articles and speeches. The report is a follow-up to Galexia's previous AusAID funded project to harmonise e-commerce legal infrastructure in ASEAN (2004-2009) and Galexia’s earlier study for the UNCTAD Information Economy Report on ASEAN cyberlaw harmonisation in 2008. It also makes proposals for accelerating the process of regional integration and harmonization as outlined in the ASEAN ICT Masterplan 2015.
Our consultants performed an analysis of AEMO's authentication requirements, internal and external applications, and existing processes. The review considered the operation of the Code and encompass accountability, effectiveness, efficiency, accessibility, independence and fairness.
The Scorecard also finds that policy fragmentation persists, as some countries, aiming to promote local cloud markets, adopt laws and regulations that inhibit cross-border data flows or skew international competition.
The biggest mover in the rankings is Singapore, which vaulted to fifth from 10th place a year ago by adopting a new privacy law that builds user trust while also promoting business innovation. Notably, all six European Union countries covered in the study have lost ground in the rankings. It also provides insight into how regulation and policy work address cloud computing issues. It measures key attributes and conditions that will help companies and individuals determine which markets are currently best placed for wide adoption of cloud computing services.
The new scorecard examines the legal, regulatory and infrastructure environments in 24 countries, including a detailed assessment of their readiness for cloud computing. The new ePayments Code replaces the long standing EFT Code of Conduct, and applies to a broader range of online payment systems. A public consultation paper issued by the Ministry of Information, Communications and the Arts was released on 13 September 2011, titled: Proposed Consumer Data Protection Regime For Singapore. Interestingly, the paper also proposes the establishment of a national Do Not Call Register to fight against the intrusion of telemarketing.
Appropriate collection, management, linkage and interrogation of health data can play a vital role in improving individuals’ health and wellbeing.
This initiative is likely to attract new researchers to the field of population health, and the current review may assist them in taking account of privacy regulation and perceptions when designing study and consent processes. In particular, significant concerns regarding consent and de-identification remain in the community. Recent advances in the techniques for de-identifying personal information provide some hope that de-identification can occur without a negative impact on data quality.
The presentation focussed on areas where the region is making good progress on developing consistent and harmonised laws and regulations that facilitate cloud computing. This important comparative analysis was commissioned by the Business Software Alliance (BSA). The United Nations Convention on the Use of Electronic Communications in International Contracts (Electronic Contracts Convention) and the Council of Europe Convention on Cybercrime (Cybercrime Convention).
The Convention covers a range of criminal activity involving use of computers or computer networks, such as in unlawfully accessing computer data or interfering with computer systems, or where computer use is integral to the offence, such as for the distribution of child pornography via the Internet. Seventeen other nations have signed the Convention, including non-members Canada, Japan and South Africa. However, they also advised that Australia would lodge a Reservation to requirements for foreign investigation of real-time data to ensure they matched Australian thresholds - in particular, Australian law limits disclosure of real-time traffic data to investigations relating to a criminal offence punishable by at least three years’ imprisonment. Communications privacy complaints: in search of the right path was launched by the Australian Communications Consumer Action Network (ACCAN).
The Act introduces protections for personal information, including requirements of and restrictions on private sector data users and rights of data subjects.
Galexia assisted with the design, development and implementation of automated provisioning, password synchronisation and data cleansing for University staff and students. Galexia assisted with the development and implementation of a security and provisioning solution for University staff and students.
The seminar was part of the Continuing Legal Education seminar series run by the Faculty of Law at the University of New South Wales. They gave the participants the opportunity to make the most objective opinion on the changes in the field of public procurements. During another session he presented a report on “Law Labyrinth of Legal Support and Appeal of Procurements Outcomes.
The term for making the decision on or the rejection of the state registration has been reduced to 10 business days.
Please note, that the Ministry of Economic Development is mentioned for the first time in the context of the state registration of medicinal products and previously was not involved into any step of the registration process. In addition, we would like to mention a substantial expertise and due attention to this issue expressed by Antimonopoly Committee specialists. The reimbursement of insulin products costs shall be fulfilled at the rate of reference price for the medicinal product approved by the Ministry of Health of Ukraine.
The patients shall receive their medication for a lowered price or for free in accordance with these categories.
Business entity should submit the relevant report not later than the 5th day of the month following the reporting month, and in December — not later than the 24th day of the reporting month. An important selection criterion is the presence of experience of the evaluation of the comparative efficacy (effectiveness), safety and cost-effectiveness of drugs. This Order updates the mailing procedures for tax assessment notices to be sent to taxpayers by regulatory authorities. Today the AMCU increased the penalty up to 30% of the revenue from the sales of the products (goods, works, services) that violated the legislation on the protection against unfair competition. In the end of the session the Legal Alliance senior associate Alexander Bondar presented a report on the new public procurements law, which practically implements the electronic procurements (electronic auction), electronic system of appeal, and the exchange of information, documents, submission of explanations in the electronic procurements system.
In the course of his report the delegated had an opportunity to discuss the plans and implementations of 2015 and to share their expectations and forecasts for the coming year. After he passed the floor to the special guests of the conference - Aliona Kushnova, Judge at the regional Kiev administrative court, and Jonas Triggvason, Managing Partner, UPharma Consulting. The session was traditionally opened with an analytical report on the status of the pharmaceutical market in 2015 presented by Irina Gorlova, General Director, SMD. Vitalii Savchuk, Senior Associate, Legal Alliance, presented a report on the most high-profile cases, investigations and court practices regarding the pharmaceutical industry.
It also includes a detailed history of attempts to reform the Safe Harbor agreement, culminating in the proposed EU-US Privacy Shield in 2016. Russia and China, in particular, have imposed new policies that will hinder cloud computing by limiting the ability of cloud computing service providers to adequately move data across borders. The Scorecard analysis is based upon a combination of published information and statistics and evaluation by independent experts at Galexia. The week concludes with the launch of the UNCTAD B2C E-Commerce Index 2016 (Measuring Cross-Border E-Commerce).
It will explore the complexity of cross-border enforcement and ways in which governments and businesses can work together in these areas.
Mr Connolly provided an overview of national approaches to cloud computing policy and regulation, with a special emphasis on the issues facing developing countries. We used our expert knowledge of cloud-based SSO technology vendors and solutions to select and cost the best approach, based on proven cloud identity design principles and best practices. The 2013 study finds that Japan continues to lead the global rankings with a comprehensive suite of laws supporting digital commerce. Others are effectively unplugging themselves from the global market — with especially counterproductive policies in Korea, Indonesia and Vietnam. Connolly, Privacy and the use of health data for research, Med J Australia 193 (2010), 537-541. However, the assembly and use of linked population, clinical and genetic health databases in the research and policy analysis environments raises privacy, confidentiality and ethical concerns. Some regional gaps and challenges were also identified in areas such as data protection law, cybercrime legislation and ICT infrastructure.
The Act will also create a Personal Data Protection Commissioner, an advisory committee, and an appeals tribunal. Our joint efforts led us to the implementation of the project that only yesterday seemed to be almost impossible”. The reports should be submitted to local budgets holders who have been legitimately assigned for the execution of operating expenses of local budgets for preferential provision of insulin products to diabetic patients defined by the decisions on such expenditures in accordance with the legislation for the reimbursement to business entity of the amount stated in the register within 15 days upon the report receipt.
In addition to a lot of interesting facts the reporter highlighted that the total volume of the medicinal products market in Ukraine amounted to 2.1 billion USD in 2015.
Each group of questions is weighted to reflect its importance to cloud computing and each individual question is also weighted to reflect its importance within the group.
It will also discuss measures by companies, in particular small and medium-sized enterprises, to keep consumer information secure. Australia remains in second place, and the US has edged into third, pushing Germany down to fourth. Volodymyr Redko, Executive Director of Association of Pharmaceutical Research and Development APRaD.
To help with the scoring and usability of the study, the assessments are based on a  series of questions that are framed so that a "yes" response reflects a favorable policy setting for global cloud computing.
To help with the scoring and usability of the study, the assessments are based on a series of questions that are framed so that a "yes" response reflects a favourable policy setting for global cloud computing. In the framework of this session the participants discussed the adjustments in the personal data protection, as well as promotional activities and programs of the pharmaceutical companies.
The weights are shown in the table below and the results are available in the downloadable report. The best retail figures are shown by dietary supplements, patients care items and medicinal products, the worst figures – personal care products and cosmetics. Session speakers - Zoya Zamikhovska, Junior associate, Lidiya Sangarovskaya-Gulach, Senior associate, and Andrii Gorbatenko, Associate partner, who presented to the audience their reports on medicinal products advertising, marketing agreements in the pharmacy sector, and distribution contracts. Andrii Gorbatenko emphasized the types of law infringements foreseen by the competition law, and paid the attendees attention to the provisions of distribution contracts, which are attracting a close attention of the Antimonopoly Committee of Ukraine, in particular the provisions regulating the reports, discounts and bonus payments.



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