The Regulation on Promotional Activities For Human Medicinal Products (“Regulation”) has entered into effect. The Turkish Pharmaceuticals and Medical Devices Agency (the “Agency”) published the Regulation in the Official Gazette on 3 July 2015 (numbered 29405) and it came into effect on the same date. The Regulation supersedes former regulation on the subject (published in the Official Gazette on 26 August 2011, numbered 28037; “Former Regulation”), while broadening the legislative scope to include promotion of enteral nutrition products and medicinal foods. The Regulation introduces new provisions for promotion of medical products, donations, value transfers and distribution of free samples.
The Regulation contains many similar or identical provisions to the Former Regulation. However, the Regulation introduces some completely new provisions, particularly related to the medicinal product market. Significant new provisions in the Regulation include:
– Prohibition on Promoting Certain Products: Article 6/2(c) of the Regulation prohibits promotion of products which are either licensed or permitted in accordance with the applicable regulations, procurement of which, in the absence of supply within the country, is carried out through foreign suppliers on the basis of prescriptions, as permitted by the Agency. An exclusion applies to promotions regarding pharmacovigilance of such products which the Social Security Institution procures from foreign suppliers with alternative repayment methods, as permitted by the Agency.
– Donations: Article 6/10 of the Regulation states that license/permit holders can make donations to non-profit health institutions, incorporations and organizations, provided certain criteria are met. Previously, license/permit holders were only permitted to make donations to public health institutions and incorporations.
– Publication of Presentations on the Agency’s Website: Article 7/10 of the Regulation carries forward a provision from the Former Regulation which states that 60% (per calendar year) of meetings which are organized or contributed to by license/permit holders and which exceed six hours must include a session on rational medicine use. The Regulation introduces a new requirement that the presentations from these sessions can be published on the Agency’s website, including information about the presentations’ source.
– Limit on Distribution of Free Samples: Article 9/1(e) of the Regulation states that a list of samples prohibited from being distributed will be published on the Agency’s website. The list will published by 1 January 2016.
– Limit on Value Transfers: Article 11/7 of the Regulation requires license/permit holders to inform the Agency of value transfers over a certain threshold which are made to the health institutions and incorporations, universities, health professionals and their professional bodies, unions, associations, foundations and NGOs. Value transfers which exceed 10% of the monthly gross minimum wage must be notified to the Agency. License/permit holders must also obtain written consent from the recipients of value transfers over this threshold.
– Administrative Sanctions: The Regulation extends the scope of administrative sanctions in Article 13 to include promotion representatives.
– Transition Period: Transitional Article 1 of the Regulation states that license holders must submit agreements to the Agency which were executed with companies for promotion activities before the Regulation came into effect. These agreements must be submitted within six months of the Regulation’s effective date.
Please see this link for the full text of the Regulation (only available in Turkish).
The Turkish Constitutional Court (“Constitutional Court”) has published the full text of its decision to cancel Transitional Article 8 and Transitional Article 14 of the Electricity Market Law numbered 6446 (“Electricity Market Law”). The Constitutional Court struck out the articles in a decision dated 22 May 2014 (numbered 2013/65E, 2014/93K). However, the decision’s full text has now been published (Official Gazette dated 24 June 2015, numbered 29296), including the detailed grounds for the cancellation.
The Constitutional Court deemed Transitional Article 8 of the Electricity Market Law to conflict with Article 2, 5 and 56 of the Turkish Constitution. It further held that Transitional Article 14 conflicted with Article 2 and 138 of the Turkish Constitution.
According to the now cancelled Transitional Article 8, the Electricity Generation Company (“EÜAŞ”) or affiliates, subsidiaries, businesses and business departments (including any assets held by these entities), as well as public generation companies established within the scope of Law numbered 4046, would be granted until 31 December 2018 to complete certain investments and obtain the permits required by environmental legislation. To qualify, the investment must support the entity to comply with environmental requirements. The period would also be granted if an entity were privatized. During the period, the qualifying entities noted above would not be required to cease generation activities or receive administrative fines. Under the Transitional Article, the Council of Ministers could extend this period up to three years.
The Constitutional Court states in its recently published decision that Transitional Article 8 prevents the administration from supervising whether generation activities comply with environmental restrictions. Therefore, the article creates an uncontrolled area for electricity generation and hampers the government in fulfilling its supervision duty. The Constitutional Court held that Transitional Article 8 is contrary to sustainable environmental principles and violates the principle of proportionality because power plants linked to EÜAŞ and privatized power plants would not be subject to environmental legislation. The Constitutional Court’s decision to strike out Transitional Article 8 comes into force six months after the full text of the decision was published in the Official Gazette (on 24 June 2015).
Transitional Article 14 of the Electricity Market Law stated that license holders who began construction of power plants before the Electricity Market Law’s effective date on the basis of a valid production license, which has since been cancelled or ceased for any reason, will be issued a license within one year of Transitional Article 14 entering into force. The Transitional Article stated that a license would be granted provided that an application is made to the Energy Market Regulatory Authority and the Ministry of Energy and Natural Resources determines the production plant investment is at a point of no return, and that there is a public interest. The Constitutional Court struck out Transitional Article 14 on the grounds that it is contrary to the principle that the administration should immediately execute judicial decisions.
You can read the full text of the Constitutional Court’s reasoned decision at this link (only available in Turkish).
The Turkish Constitutional Court (“Constitutional Court“) has struck out recent amendments to Article 15 and Transitional Article 8 of the Municipality Code numbered 5393. The amendments were introduced in late 2014 and restricted establishment of liens over municipal assets. The Constitutional Court deemed the amendments unconstitutional on the basis they prevented individuals from claiming receivables, as well as being contrary to the principle of legal certainty.
The amendments were introduced by Omnibus Bill numbered 6552, dated 10 September 2014. However, the Ankara 11th Civil Enforcement Court referred the amendments to the Constitutional Court, claiming they were unconstitutional.
In a reasoned decision dated 17 June 2015, the Constitutional Court implies that the amendments were intended to ensure continuity of municipal activities. The Constitutional Court considered the competing interests between provision of public services and individuals’ rights to claim their receivables. However, the court ultimately determined the amendments to unconstitutionally prevent individuals from exercising their rights, or rendering their further exercise of rights ineffective.
The summarized amendments and Constitutional Court responses are as follows:
– Amendment: Before execution offices decide in favor of an attachment, municipalities are requested to present assets sufficient to satisfy their debts. Creditors of municipalities could only apply attachments to assets declared by the municipalities.
The Constitutional Court struck out the phrase “the attachments shall be established solely on the declared assets“. The court reasoned that even though debts could be satisfied by other assets held by municipalities, this restriction prevented individuals proceeding with their claim because it is subject to municipalities’ declaration.
– Amendment: If a municipality failed to declare sufficient assets to secure its debts within ten days, the attachments must be established in a manner not exceeding the amount of the receivables or interrupting the provision of public services.
The Constitutional Court struck out the phrase “the attachments shall be established in a manner preventing the provision of public services“. The court expressed a concern that the vagueness of the term “public services” could prevent individuals collecting receivables if all municipal assets are instituted for the provision of public services.
– Amendment: The amendments would apply to ongoing proceedings and attachments which failed to comply with the amendments would be removed.
The Constitutional Court deemed this to conflict with the principle preventing retrospective application of laws. The court also ruled that it harmed individuals’ trust in the government and the law by removing attachments which were established in line with court decisions, thus rendering their prior exercise of rights ineffective.
You can read the full text of the Constitutional Court’s reasoned decision at this link (only available in Turkish).
In a civil case published recently (2007/6321 E, and 2008/8591 K), the 11th Civil Chamber Court of Appeal (“Court of Appeal”) held that a United States citizen plaintiff was not required to deposit the security bond which is usually required from foreign plaintiffs. The Court of Appeal held that citizens of countries which are party to Paris Convention For The Protection Of Industrial Property (“Paris Convention”) are not required to deposit a security bond in actions filed regarding their industrial rights.
According to Article 32 of the Law on Private International Law and International Civil Procedure (the “MOHUK”), foreign individuals and legal entities which file a lawsuit, intervene in a lawsuit, or initiate execution proceedings before a Turkish court, must deposit a security bond. The court sets the security bond amount in each case to cover the cost of the legal procedures and proceedings, as well as the counterparty’s potential losses or damages.
The plaintiff in the dispute was an automobile producer. It sought various remedies and compensation regarding use of its trademark within Turkey.
The first instance court refused the action on the basis that it did not have jurisdiction to hear the case. Both the plaintiff and respondents appealed the decision. The respondent argued that since the plaintiff is a Unites States citizen, it must meet the bond requirement for foreign plaintiffs outlined by Article 32 of the MOHUK.
The Court of Appeals held that in actions based on industrial rights, Article 2 of the Paris Convention applies to mean that nationals of countries to Paris Convention should receive treatment as if they were nationals of the signatory countries. Therefore, the Court of Appeals held that the United States citizen plaintiff was not required to pay the security bond, since both countries are party to the Paris Convention.
The Higher Planning Council (“Council”) has adopted an Entrepreneurship Strategy and Action Plan for the 2015-2018 period (“Action Plan”), prepared by the Small and Medium Enterprises Development Organization. The general purpose of the Action Plan is “to disseminate the entrepreneurship culture, to create a strong ecosystem and to develop entrepreneurship in Turkey”. The Action Plan envisages six strategic objectives and 64 specific actions.
The Action Plan’s strategic objectives are:
– Improving the regulatory framework to be more entrepreneur friendly: Specific actions include removing regulatory obstacles for entrepreneurs and giving second chances to bankrupt entrepreneurs.
– Supporting innovative entrepreneurship: Specific actions include encouraging establishment of business incubators specific to young entrepreneurs, supporting techno-related entrepreneurs and allocating space for business incubators in technology development areas.
– Implementing and improving a sustainable entrepreneurship support system: This objective is particularly focused on key strategic entrepreneurship areas such as women, young people, environment, social, and global. Specific actions include developing collaboration between the private and public sector, holding competitions in universities to develop social entrepreneurship, supporting projects for women’s entrepreneurship and attending European Union young entrepreneurship programs.
– Improving entrepreneurship culture: Specific actions include preparing public service announcements about entrepreneurship and disseminating youth-oriented entrepreneurship education.
– Disseminating entrepreneurship education and improving the consulting system aimed at entrepreneurs: Specific actions include inserting entrepreneurship education into primary, secondary and university curriculums, disseminating education by the Small and Medium Enterprises Development Organization and establishing entrepreneurship clubs.
– Facilitating access to financing: Specific actions include ensuring public support to venture capital funds, supporting launch of at least one covering fund for start-ups, conducting research into alternative financial instruments, and developing the concept of the “Entrepreneur Banking” within the banking system.
The Council’s decision was published in the Official Gazette on 1 July 2015, numbered 29403. Please see this link for the full text of the Council’s resolution, dated 18 June 2015 with no. 2015/18 (only available in Turkish).
The Union of Chambers and Commodity Exchanges of Turkey (“TOBB”) has encouraged chambers of commerce to use a logo and slogan combination launched in April 2015. The combination includes the words “Türkiye – Gücünü Keşfet ve Turkey – Discover The Potential”, along with a logo (“Turkey Trademark”). The Turkey Trademark project is an effort to unite the country’s values under a common trademark and establish an advantageous position on the global stage.
The Turkey Trademark was created by a group including leading names from industry and business, members of universities, government institutions, as well as non-governmental organizations. The Turkey Trademark has a range of variations, which can be seen at this link. Earlier in 2015, the Prime Minister’s Office published a Circular announcing information about the Turkey Trademark in the Official Gazette (dated 11 April 2015, numbered 29323).
TOBB also informed chambers of commerce about the Turkey Trademark Watch Commission, which was established to:
– Coordinate domestic and foreign promotion activities related to the Turkey Trademark,
– Evaluate the necessary steps for effectively using the Turkey Trademark,
– Coordinate application and amendment of regulations regarding the Turkey Trademark,
– Resolve any problems which may arise during use of the Turkey Trademark, and
– Evaluate any use of the Trademark which contradicts Turkey’s vision, image, or the usage guidelines
Detailed information and usage guidelines for the Turkey Trademark can be found at this link. Below is one variation of the Turkey Trademark.