Analytics Publications Pharmaceuticals and life sciences

2
August
2017

Looking for an equivalent: when form and dosage requirements do not limit competition

Regulatory enforcement practice in the area of public procurement for pharmaceutical drugs is developing dynamically. The diversity of situations in life gives rise to different approaches adopted by law enforcement to interpret existing regulations. From this standpoint, practices observed in June and July 2017 in regard to procuring drugs used to treat tuberculosis are interesting. Specifically, we propose focusing attention on the approach taken by the antimonopoly authorities to evaluating the form and dosage requirements for the drugs that are procured.
Сollective of authors, VEGAS LEX
Medicinskiy vestnik (Medical bulletin)
19
June
2017

The fight with cartels reaches a new level

Medicinal products and medical equipment, according to data from the Federal Antimonopoly Service, occupy one of the leading positions in the list of commodities markets that are most affected by cartel collusion. Andrey Tenishev, Director of the Anti-Cartel Department at the Federal Antimonopoly Service, points out that the level of cartelization in public procurement for medicinal products might be around 50%. Recently, antimonopoly authorities presented a multivariable system to identify cartels during electronic bids. By using this program, it is possible to remotely identify and prove cartel collusion during electronic bids in any region or across any industry. A certain amount of time needs to pass before the effectiveness of this solution can be evaluated. However, even now it is evident that fighting cartels requires new, improved approaches.
Pharmaceutical Bulletin
3
May
2017

Implementing the Protocol for the compulsory licensing of pharmaceuticals for WTO members will require the introduction of a comprehensive set of amendments into Russian Federation legislation

On April 24th, 2017, the Russian Federation Government's Committee on legislative bills approved a bill to adopt a protocol to amend the WTO agreement that will, in the future, allow WTO members to issue compulsory licenses to produce pharmaceutical drugs for export and, if necessary, to invoke immunity when other WTO members challenge their actions. However, according to one expert, achieving the goals that have been declared is not an unambiguous process – especially because applying suitable mechanism will entail a comprehensive set of amendments to current Russian Federation legislation.
Remedium
4
April
2017

The subtleties of licensing induced abortion services

Induced abortion is a type of medical intervention, and is subject to medical licensing regulations. At the end of 2016, the Russian Federation government made changes in the procedure for obtaining abortion licenses, and gave medical organizations a year to adapt to the new requirements. What needs to change because of this, and what further steps are required from medical clinic directors?
Medicinskiy vestnik (Medical bulletin)
21
November
2016

Russian pharmaceutical market today and tomorrow – legal overview

The Russian pharmaceutical market is one of the fastest growing in the world, and it has always been attractive for foreign pharmaceutical manufacturers. However, a policy on import substitution, defined in the State Program "Development of Pharmaceutical and Medical Industry for 2013-2020," resulted in elaboration of several restrictive initiatives. At the same time, certain new regulatory instruments were introduced to create additional incentives for localization and investments. Therefore, the key purpose of this overview is to describe the main regulatory trends, associated legal risks and opportunities for pharmaceutical manufacturers in 2016-2017 in Russia.
The Pharma Letter
5
October
2016

Elusive preference

Russian manufacturers of drugs, involved in public tenders, have had a 15% preference when it comes to pricing for quite a long time already. However, in connection with the adoption of additional measures to stimulate the localization of production, the question of determining the country of origin of goods has become particularly relevant. In recent years, practice has shown that certain contradictions exist in the approach to addressing this issue on the part of law enforcers.
Medicinskiy vestnik (Medical bulletin)
14
July
2016

Get out of the drawbar

The Law on “Circulation of Medicines” is in a state of transformation
Pharmaceutical Bulletin
21
April
2016

Forced licensing

Over the past few years, in the pharmaceutical sector there have been live discussions taking place on the possibility of introducing compulsory licensing for the purposes of regulatory practice, with the goal of reducing drug prices and increased access to treatment by the population. Some experts referred to the positive examples of international experience in the application of compulsory licenses (India, Thailand, Brazil, etc.), drawing analogies between the markets of developing countries and the market of the Russian Federation. At the same time, extreme caution needs to be used when borrowing solutions from international experience, regarding the use of compulsory licenses.
EZH-Yurist
6
April
2016

Overview of the judicial practice in the field of production and circulation of medical products in December 2015, February 2016

In this monthly review, we analyse the judicial practice in the field of manufacturing and circulation of medical products, in order to help industry professionals avoid mistakes in dealing with similar problems.

Remedium
5
October
2015

Restrictions on state procurement of foreign medical devices: practice and implications for other sectors

On 5 February 2015 the Russian Government adopted Resolution No. 102 "On Restricting the Access of Certain Types of Medical Devices Originating from Foreign Countries for the Purpose of Procurement for State and Municipal Needs" (Resolution No. 102). Resolution No. 102 contains a closed list of medical devices to which its provisions apply (the "List").

AEB Business Quarterly
4
July
2017

Such different kinds of interchangeability

Interchangeability regarding medicinal products contains many facets. Today, we will look at one concerning procurement not for inpatient treatment, but for providing people with preferential outpatient treatment (outside the hospital).
Сollective of authors, VEGAS LEX
Medicinskiy vestnik (Medical bulletin)
18
May
2017

Down a thorny path towards interchangeability

According to the consolidated approach that has formed during the process of supervising public procurement practices, interchangeable drugs are medicinal products with identical international non-proprietary names with interchangeable dosage forms and dosage amounts. However, the stance taken by regulatory enforcement practices is taking on a pattern that includes the possibility of recognizing medicinal products with different international non-proprietary names as interchangeable.
Medicinskiy vestnik (Medical bulletin)
5
April
2017

From the patient to the budget and back again

The law obligates government buyers to procure medicinal products according to their INN (International Non-Proprietary Name). Law enforcement officials continue to argue about the degree to which the current rules of law allow for exceptions. However, the question must be put another way – which decision best suits the patients’ interests?
Pharmaceutical Bulletin
22
February
2017

The third exception

As is well-known, as per the provisions in federal law №44-FZ, a customer is obligated to procure pharmaceutical drugs in accordance with their international nonproprietary names. There are only two exceptions - medications from a list, which has not yet been approved, of pharmaceutical drugs whose purchase is to be made in accordance with their tradenames, and medications for the treatment of life-threatening situations. However, even in 2007 there was an approach that formed in judicial practice that allows the purchase of the tradenames insulin and cyclosporine.
Medicinskiy vestnik (Medical bulletin)
11
November
2016

Prospects for SPIC in the pharmaceutical sector

One of the instruments to promote localization, in accordance with the Federal Law dated 31.12.2014 No. 488-FZ "On Industrial Policy in the Russian Federation", is the special investment contract (hereinafter the “SPIC”). The SPIC mechanism can be implemented in a variety of industries, including the pharmaceutical sector and the medical devices manufacturing sphere.
EZH-Yurist
25
July
2016

Disparate & interchangeable

The Russian Federal Antimonopoly Service in its clarifications repeatedly reported the position of the service on the interchangeability of certain drugs. In particular, a letter dated 9 April 2014 No. AK/13610/14 stated that the different dosages of drugs should be considered as interchangeable, if there is the possibility of multiple comparisons. At the same time, the practical application of this principle is not universal.
Medicinskiy vestnik (Medical bulletin)
30
May
2016

They were not ready

On 30 November 2015, the Russian Government adopted Decree No. 1289, which embodies the concept of the “three’s a crowd” in the pharmaceutical sector. Despite the fact that this format of regulations has been discussed during the last few years, no government customers or suppliers of drugs were ready for the introduction of this document.
Medicinskiy vestnik (Medical bulletin)
6
April
2016

Major trends in IP practices in the pharmaceutical sector

Protection of intellectual property is a necessary foundation for the development of innovation in the pharmaceutical industry. The effectiveness and scope of patent protection, which are provided to developers of drugs, are extremely important to bring to market new treatment technologies. The higher the regulatory guarantees of protection of exclusive rights, the greater the incentives created for innovative manufacturers to invest into the development of new and improvement of existing drugs. However, in many respects, the effectiveness of patent protection depends on enforcement practices in a particular sector of the economy. In this regard, it is important to monitor the dynamics of the main approaches of courts of different levels when it comes to resolving patent disputes in the pharmaceutical sector.
Remedium
7
December
2015

Responsibility for non-fulfilment

In accordance with Paragraph 4 of Article 34 of the Federal Law dated 05 April 2013 No. 44-FZ “On the contract system in the procurement of goods, works and services for state and municipal needs” a contract must include mandatory provisions outlining the responsibility of the customer and the supplier for any failure to perform, or improper performance of obligations under the contract. At the same time, current legal practice shows that the formulation of provisions on such responsibility in the contract poses certain difficulties, and some nuances need to be understood.
Medicinskiy vestnik (Medical bulletin)

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