Правовые вопросы фармацевтической отрасли

The «Legal Issues in Pharmaceutical Industry» Conference

The current environment pushes all industries to face a new reality. This is particularly true in the case of the pharmaceutical industry, as it has lately been concerned with a number of adopted enactments and laws. Market participants note that emerging support measures, in line with the adoption of respective enactments and their implementation thereof, would entail risks that outweigh the possible advantages, while judicial practices prove to be inconsistent. All of this negatively affects the national investment climate. It is important to note, that public agencies, professional communities, and pharmaceutical companies still maintain a dialog, which is becoming more open and clear as never before.

The following issues will be raised at the conference

• Change in the pricing rules for medications from the list of vital and essential drugs. Procedure for updating the list of vital and essential drugs.
• Improvement of legislation and regulations governing the organization and conduct of state procurement. Analysis of law enforcement practices. Violations overview.
• Possibility of restoring the rights of the participant in the purchase of medicines. Experience of pharmaceutical companies.
• The breach of intellectual rights. The possibility to determine the fair size of (compensation) losses incurred by the rights holder.
• Competitive legislation and intellectual property legislation. The effective use of compulsory licensing.
• A legal assessment of various compulsory licensing tools. Risks VS advantages.
• The parallel import of pharmaceutical products: budget-saving against shrinking foreign investments and the spread of infringing goods. Measures of protection against such risks.
• Regulation of online pharmaceutical sales. View of the government and business community, expert advice and suggestions.

The target audience of the Conference are the heads of legal departments of major Russian and foreign pharmaceutical companies, representatives of government bodies, lawyers, as well as acknowledged experts in medical science and healthcare.

Industries

• Pharmaceutical industry
• Chemical industry
• Pharmacy chains and distributors
• Legal companies

Officials

• CEO / General Director / President
• New Business Director
• Executive Director
• Production Director
• Director of Drug Availability, Corporate Relations and Interaction with Public Authorities
• Legal Director, Procurement Director
• Lawyers

PROGRAM

09:30 a.m. – 10:00 a.m. Participant registration. Coffee

10:00 a.m. – 12:00 p.m. Strategy session. Public procurement and pricing of medicines as priority spheres of state regulation of the Russian pharmaceutical market

«Pricing: Specific Features and Innovations» Track

• State regulation of medicine pricing. Change in the pricing rules for medications from the list of vital and essential drugs
• Procedure for updating the list of vital and essential drugs.
• Control and supervision of the application of prices for the list of vital and essential drugs.

«State Procurement: How to Cure a Sick Person» Track

• Improvement of the legislation and regulations governing the organization and conduct of bidding: key changes in 2017, plans for 2018.
• Analysis of law enforcement practices. Review of customer violations of the rules for organizing the preparation and conduct of competitive procedures for the purchase of medicines.
• Possibility of restoring the rights of the participant in the purchase of medicines. Experience of pharmaceutical companies.

12:00 p.m. – 12:30 p.m. Coffee break

12:30 p.m. – 2:00 p.m. Expert session. Intellectual property: relevant practices

Topics for discussion

• Violation of intellectual property rights. Is it possible to determine the fair amount of (compensation) damages incurred by the rights holder? How can the balance between the rights and legal interests of all parties in the proceedings be ensured?
• Competition legislation and intellectual property legislation. The effective use of compulsory licensing.
• Legal assessment of various compulsory licensing tools: risks and advantages.
• The parallel import of pharmaceutical products: budget-saving or reducing foreign investments and increasing the number of counterfeit goods? Measures of protection against such risks.

2:00 p.m. – 2:30 p.m. Coffee break

2:30 – 4:00 p.m. Panel discussion. Initial step: regulation of online pharmaceutical sales. The view of the government and business community, expert advice and suggestions.

Topics for discussion

• Rules for the remote sale of medicines: what will they be?
• What mechanisms for controlling the e-commerce trade of pharmaceuticals are necessary for the market?
• Online sale of medicines via the uniform state automatic information system VS setup of the state register of online pharmacies: which of these variants is more preferable?

4:00 p.m. – 5:00 p.m. Lunch