It has been 3.5 years since Russia joined the World Trade Organization (WTO) and implemented the right of data exclusivity for innovative pharmaceutical products. In this short period of time, the definition of data exclusivity has changed and precedent setting litigation has ensued. In this post, I attempt to delineate the most important events to date regarding data exclusivity in Russia and evaluate its protective potential. Background Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) specifies that the members of the WTO shall take the necessary steps to ensure the protection of undisclosed proprietary data submitted to obtain the registration of a pharmaceutical product, the origination of which involved considerable effort.Upon accession to the WTO, Russia documented its agreement to ensure the protection of undisclosed information and test data in paragraph 2 of the Protocol of Accession of the Russian Federation to the WTO. The … [Read more...] about Current State of Data Protection and Exclusivity in Russia
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On 14 September 2017, a draft of the new Personal Data Protection Act “implementing” EU General Data Protection Regulation (the “PDPA Draft”) was published as well as a draft amending numerous sectoral laws (“Amending Act Draft”). As announced by the Minister for Digitization, the drafts are to be subject to extensive public consultation.Here are the key issues covered by the announced drafts. Electronic Services for Children Under 13 Years of Age and Consent to Data ProcessingIn the case of electronic services offered directly to a child under the age of 13 and staying in the territory of Poland, where the basis of data processing is the consent of the child, processing will only be possible with the prior consent of the legal representative of the child, or immediately after confirmation by the legal representative of the consent expressed by such child. Certificate of the Compliance With GDPRThe GDPR provides for the possibility of establishing … [Read more...] about The Polish Draft of the New Personal Data Protection Act – Announced!
The General Data Protection Regulation will apply to the UK when it is effective on May 25, 2018, but the government will need to adopt domestic data privacy legislation upon the UK’s pending exit from the EU.The United Kingdom’s data protection laws are derived from European Union legislation such as the Data Protection Act 1998 (DPA) and the Privacy and Electronic Communications Regulations, which implement European Directives. The EU’s new General Data Protection Regulation (GDPR), which will replace the DPA, will be in force on May 25, 2018. The GDPR will be effective in the UK immediately on this date, without any further UK laws being required. The UK government will need to enact domestic data privacy legislation to replace the GDPR when the UK exits the EU. The UK’s data protection authority, the Information Commissioner’s Office, has already advised the government that UK data protection standards will need to be equivalent to those in the GDPR if … [Read more...] about How General Data Protection Regulation Will Apply to and Affect United Kingdom
On December 17, 2015, European Union officials approved a new General Data Protection Regulation ("GDPR"). The GDPR will likely be signed into law in January 2016 and take effect early in 2018. The GDPR will replace the current EU Data Privacy Directive. The GDPR will create a consistent data protection standard throughout the European Union and set a higher global standard for personal data protection.The GDPR applies to any company that does business with European customers or European employees, whether or not the company has physical operations in the EU.Beware of Eight Figure PenaltiesCompliance with the GDPR will be critical. EU data protection regulators will now have authority to issue penalties equal to the greater of €10 million ($10.82 Million) or 2% of the entity's global gross revenue for violations of record-keeping, security, breach notification, and privacy impact assessment obligations. Violations of obligations related to legal justification for processing, data … [Read more...] about EU Strengthens Global Data Protection Regulations: Steps You Can Take Now to Ensure Compliance
Florida businesses will soon have an important and powerful new legal cause of action to combat unauthorized access to protected computer systems or data by employees, former employees, directors, officers, and others. Florida's Computer Abuse and Data Recovery Act (CADRA) goes into effect on October 1, 2015.CADRA is intended to be a national model for legislation providing a new civil remedy (and recovery of reasonable attorneys' fees) to business owners who suffer harm or loss as a result of unauthorized access to their business data or computer systems. To take advantage of CADRA's protections, businesses must protect their computers by installing certain “technological access barriers,” or TABs, defined in CADRA.An individual violates CADRA when he or she “knowingly and with intent to cause harm or loss”: (1) obtains information from a TAB-protected computer without authorization and as a result causes harm or loss; (2) causes the transmission of a program, … [Read more...] about Florida’s CADRA a Powerful New Data Protection