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Archive for: Polish Act on Pharmaceutical Law

Advertising of pharmaceuticals, case VI SA/ Wa 1136/10

July 29th, 2010, Tomasz Rychlicki

This is the continuation of a story described in “Advertising of pharmaceuticals, case II GSK 461/09“. The Voivodeship Administrative Court in Warsaw in its judgment case file VI SA/ Wa 1136/10 canceled the decision of the Main Pharmaceutical Inspector (MPI) that ordered the Polish Federation for Women and Family Planning (in Polish: Federacja na rzecz Kobiet i Planowania Rodziny) to remove information about different contraceptions. Such information was published on the website operated by the PFWFP. Being bound by a legal interpretation issued by the Supreme Administrative Court, the VAC ruled that the mere use of the name of a pharmaceutical product does not prejudge that such message is advertising. One cannot automatically equate information on medicinal products with an incentive to use them.

Readability test of pharmaceutical products’ leaflet

June 2nd, 2010, Tomasz Rychlicki

In the Regulation of the Minster of Health of 26 April 2010 on the leaflet readability test (in Polish: rozporządzenie w sprawie badania czytelności ulotki), Journal of Laws of 18 May 2010, No. 84, item 551, the Polish Minister of Health provided the principles of examination under which the content of the information attached to the pharmaceutical products is understandable.

The readability test of a pharmaceutical product’s leaflet is carried out by the responsible entity (an entrepreneur who applies for or has received the marketing authorization for a medicinal product), or any other person on its behalf, to ensure that a consumer understands the relevant information contained in this leaflet and will be able to correctly apply the medicinal product. The readability test should be conducted with the following minimum requirements:
– a leaflet should be in the version that will be attached to the packaging of a pharmaceutical product, or its color layout design,
– test participants are those who may use the medicinal product, including those who have difficulty understanding written information.

The test is carried out with ten participants. A positive test result means that for each question, 90% of study participants may find the information on a given leaflet, of which 90% may show their understanding and give the correct answer and to proceed with the medicinal product.

Categories: consumer protection law | pharmaceutical law | Polish Act on Pharmaceutical Law | product packaging | regulations.

Advertising of pharmaceuticals, case GIF-P-R-450/147-3/ZW/09/10

April 28th, 2010, Tomasz Rychlicki

The Main Pharmaceutical Inspector (MPI) questioned the legality of a few ads that were aired on different TV channels. See for instance the decision of the the Main Pharmaceutical Inspector of 4 March 2010, no. GIF-P-R-450/147-3/ZW/09/10, with regard to indication of a sponsor in “The producer of Guajazyl – cough syrup, invites to a forecast” (in Polish “Na prognozę pogody zaprasza producent Guajazylu – wykrztuśnego syropu na kaszel”), the decision of the the Main Pharmaceutical Inspector of 10 March 2010, no. GIF-P-R-450/141-4/ZW/09/10, with regard to indication of a sponsor in “The producer of Pectosol – herbal preparation on cough, invites to a program” (in Polish: “Na program zaprasza producent Pectosolu – ziołowego preparatu na kaszel”), the decision of the the Main Pharmaceutical Inspector of 6 January 2010, no GIF-P-R-450/126-3/ZW/09/10, with regard to indication of a sponsor in “The producer of DEXAPINI invites to a forecast. DEXAPINI – goodnight without a cough” (in Polish: “Na prognozę pogody zaprasza producent syropu DEXAPINI. DEXAPINI – dobranoc bez kaszlu”).

According to the provisions of Article 17(1) of the Polish Act of 29 December 1992 on Broadcasting – LOB – (in Polish: Ustawa o radiofonii i telewizji), published in Journal of Law (Dziennik Ustaw) of 1993, No 7 item 34, consolidated text of 19 Novemver 2004, Journal of Laws (Dziennik Ustaw) No 253 item 2531, with subsequent amendments, sponsored programmes or other broadcasts shall be identified as such by sponsor credits at their beginning or end. Such credits may specify only the sponsor’s name, business name, trademark or contain some other identification of the business operator or its business activities, the image of a single product or service. According to article 4 pt. 7 of the LOB, the “sponsorship” shall mean a direct or indirect financing or co-financing of the production or transmission of a programme or other broadcasts by an entity other than the broadcaster or producer of the programme, with a view to establishing, enhancing or promoting the renown of the name, business name, product or service, trademark. The MPI held that publishing of information relating to the product, not the manufacturer’s is basically beyond the scope of sponsorship. The MPI ruled that these sponsorship spots were illegal advertising of the medicinal products.

Advertising of pharmaceuticals, case VI SA/Wa 2110/09

March 17th, 2010, Tomasz Rychlicki

On June 2009, the Polish newspaper Gazeta Wyborcza published an article (sort of an advertorial) containing images that depicted packagings of Stoperan and Septolete medicines, together with a note instructing that the leaflet attached to these products should also be read.

The Main Pharmaceutical Inspector (MPI) ordered the immediate cessation of such actions in a decision of 4 September 2009, case no. GIF-P-R-450-81-4/JD/09, PDF file. The MPI has fund that the publication did not meet the requirements set in the Polish pharmaceutical law with regard to advertising of medicinal products. It was not commissioned by the responsible entity and it did not contain the detailed characteristics of the products or the required and established warnings.

Agora S.A., the owner of Gazeta Wyborcza, filed a complaint to the Voivodeship Administrative Court (VAC) in Warsaw. The VAC in a judgment of 11 MArch 2010, case file VI SA/Wa 2110/09, ruled that medicines are dangerous products and therefore the strict requirements and regulations for advertising of such preparations were introduced, and they do not allow for the so-called hidden advertising. The Court agreed with MPI’s findings that the article published by Gazeta Wyborcza contained information about two medicinal products and that could encourage the use of these preparations, which is contrary to article 52(1) of the The Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo famraceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments.

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

This judgment is not yet final. A cassation complaint may be filed to the Supreme Administrative Court.

Advertising of pharmaceuticals, case II GSK 461/09

March 14th, 2010, Tomasz Rychlicki

The Main Pharmaceutical Inspector (MPI) found that Polish Federation for Women and Family Planning (in Polish: Federacja na rzecz Kobiet i Planowania Rodziny) is publishing the names of contraceptives on its Internet website, and therefore the Federation advertises these products. The MPI ordered the immediate cessation of such actions because it may encourages the use and prescription of such medical preparations and public advertisement of medicinal products as contraceptives, that are issued only on prescription, is prohibited by provisions of article 52(1) of the The Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo famraceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments.

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

The Federation filed a complaint to the Voivodeship Administrative Court (VAC) in Warsaw. The VAC in a judgment of 3 March 2009, case file VII SA/Wa 2108/08, has overturned the decision of the MPI, but only because the incomplete material was submitted. The VAC agreed that MPI’s decision was justified with regard to cessation of public advertisement of contraceptives. The Federation filed a cassation complaint.

The Supreme Administrative Cort (SAC) in a judgment of 10 March 2010, case file II GSK 461/09, ruled that the provisions of article 52 are legible and obvious, but they must relate to the circumstances of a particular case and to all reasons of actions taken in order to inform about the medicinal product. According to the SAC these circumstances were not considered and the VAC also omitted the statutory objectives of the Federation. The major role of the Polish Federation for Women and Family Planning is to inform of the various methods of family planning. Publishing the name of contraceptives, cannot be treated as an encouragement for its use. The information does not come from the responsible entity, and the publication of characteristics of medicinal products is not considered as advertising. If the order issued by the MPI was sustained, such information could not be published at all.

Therefore, the SAC annulled the questioned judgments of the Voivodeship Administrative Court and returned the case to the VAC for reconsideration.

Pharmaceutical trade marks, case VI SA/Wa 844/09

February 2nd, 2010, Tomasz Rychlicki

On 4 February 2004, the Polish company Przedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o. from Zakroczym filed to the Polish Patent Office (PPO) a trademark application for word sign GESTROL Z-275787 for the goods in class 5, cancer drugs. In a decision of 11 April 2008 the PPO refused to grant the right of protection. The PPO found that GESTROL is similar to the earlier registered trade mark (with priority date of 6 February 2003) – GESTROLTEX R-192945 registered for BIOTON S.A. from Warsaw, for goods in class 5, pharmaceutical preparations. Article 132(2)(ii) of the Polish Act of 30 June 2000 on Industrial Property Law – IPL – (in Polish: ustawa Prawo własności przemysłowej) of 30 June 2000, published in Journal of Laws (Dziennik Ustaw) of 2001 No 49, item 508, consolidated text of 13 June 2003, Journal of Laws (Dziennik Ustaw) No 119, item 1117, with later amendments, served as the basis for the decision to refuse to grant a right of protection.

2. A right of protection for a trademark shall not be granted, if the trademark:
(…)
(ii) is identical or similar to a trademark for which a right of protection was granted or which has been applied for protection with an earlier priority date (provided that the latter is subsequently granted a right of protection) on behalf of another party for identical or similar goods, if a risk of misleading the public exists, in particular by evoking associations with the earlier mark,

LEK-AM filed a request for re-examination of the matter. The company argued that the sign applied for is intended to mark the anticancer drug. The active substance in this preparation is a chemical compound of the generic name (INN) megestrol. Under the decision of the Polish Minister of Health, GESTROL as a medicinal product received authorization for marketing. The Minister of Health has not found confusing similarity between GESTROL and GESTROLTEX. LEK-AM pointed out that both trade marks will be identified in the course of the highly specialized medical personnel. The PPO rejected the request and LEK-AM filed a complaint before the Voivodeship Administrative Court (VAC) in Warsaw.

The Court in a judgment of 12 October 2009, case file VI SA/Wa 844/09, ruled that the recipient, to whom the association between the marks GESTROL and GESTROLTEX may arise, is not only a person who is reasonably well informed and reasonably observant and circumspect, but it is also a person with high qualifications. Anticancer drugs are not bought and ordained without the intermediary of a doctor. For this reason, evaluation of other state administrative body, namely the Office for Registration of Medicinal Products, Medical Devices and Biocides and it is the ORMP who sets procedures and requirements for registration of signs for medicinal products, must be considered not only as a medical evaluation of the effects of the medication but also as the situation where the ORMP does not allow for the existence of two medicinal products with the same or similar name, which would prevent the identification of the product and the source of its origin at the medicinal products market. Of course, the court agreed with the PPO’s argument that the registration of the name of the medicinal product in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at the Ministry of Health does not create an individual right to a specific drug name. Such a right exists from the time the right of protection for trademark is granted the IPL. It was obvious that the trade mark examination/registration proceedings before the PPO are independent of the proceedings before the ORMP, but it must be borne in mind that the earlier findings of one of the official bodies of Polish state cannot be neglected by another official body.

The VAC came to the conclusion that the contested decision of the PPO did not comply with the requirements of the Administrative Proceedings Code – APC – (in Polish: Kodeks postępowania administracyjnego) of 14 June 1960, Journal of Laws (Dziennik Ustaw) No 30, item 168, consolidated text of 9 October 2000, Journal of Laws (Dziennik Ustaw) No 98, item 1071 with subsequent amendments. According to article 107 §3 of the APC, the reasons for the administrative decision should include in particular: facts that the PPO considered proven, the evidence on which it relied and the reasons why the credibility of other evidence were denied the probative value, and the legal justification for the decision should be explain the legal basis for the decision, quoting the law. The VAC held the Polish Patent Office has not give sufficient reasons for, why it has refused to grant protection for a GESTROL trade mark.

The VAC annulled both contested decisions, and ruled them unenforceable. This judgment is not yet final. The party unsatisfied with the ruling may file a cassation complaint to the Supreme Administrative Court.

Polish regulations on pharmaceutical trade marks

February 1st, 2010, Tomasz Rychlicki

I. The law
The main sources of binding laws in the Republic of Poland are the Constitution of 2 April 1997, acts passed by the Parliament, ratified international treaties and regulations issued, for example, by the Prime Minister or the Council of Ministers – Polish government. Regulations are issued for the purpose of implementation of acts.

I.A. Substantive law

The Polish Act of 30 June 2000 on Industrial Property Law – IPL – (in Polish: ustawa Prawo własności przemysłowej) of 30 June 2000, published in Journal of Laws (Dziennik Ustaw) of 2001 No 49, item 508, consolidated text of 13 June 2003, Journal of Laws (Dziennik Ustaw) No 119, item 1117, with later amendments, defines the requirements for obtaining trademark protection in the Republic of Poland. There are related regulations that are issued for the purpose of implementation of the IPL.
The Polish Act of 16 April 1993 on Combating Unfair Competition – CUC – (in Polish: ustawa o zwalczaniu nieuczciwej konkurencji), Journal of Laws (Dziennik Ustaw) No 47, item 211, with later amendments.
The Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo famraceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments, defines pharmaceutical/medicinal product. Of course, there are several related regulations to the PHL and the case-law of Polish courts. The PHL is almost entirely based on EU principles.

I.B. Procedural law

Administrative Proceedings Code – APC – (in Polish: Kodeks postępowania administracyjnego) of 14 June 1960, Journal of Laws (Dziennik Ustaw) No 30, item 168, consolidated text of 9 October 2000, Journal of Laws (Dziennik Ustaw) No 98, item 1071 with subsequent amendments.
Act on proceedings before administrative courts – PBAC – (in Polish:Prawo o postępowaniu przed sądami administracyjnymi) of 30 August 2002, Journal of Laws (Dziennik Ustaw) No 153, item 1270, with later amendments.
Civil Proceedings Code – CPC (in Polish: Kodeks Postępowania Cywilnego) of 17 November 1964, Journal of Laws (Dziennik Ustaw) No 43, item 296, with later amendments.
Act on Patent Attorneys – APAT – (in Polish: ustawa o rzecznikach patentowych) of 11 April 2001, Journal of Laws (Dziennik Ustaw) No. 49, item 509, with subsequent amendments.

I.C. Case law
See “Polish case law on advertising of pharmaceuticals“.

I.D. EU law
Moreover, all EU regulations and the judgements of the Court of Justice (COJ) of European Union relating to pharmaceutical issues are directly applicable in the Republic of Poland.

II. National bodies and procedures concerning pharmaceutical trade marks
The right of protection for a sign being capable to be registered as a trade mark is granted by the Patent Office of the Republic of Poland (PPO), while the Polish Ministry of Health controls the registration process and approval procedure for medicinal products. Registration of signs for medicinal products is governed by the procedure and requirements set by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP), a government agency competent for the evaluation of the quality, efficacy and safety of medicinal and biocidal products, as well as medical devices.

The Main Pharmaceutical Inspector (MPI) is the central organ of public administration, executing her/his duties with the assistance of the Main Pharmaceutical Inspectorate and the MPI is authorized to ensure compliance with pharmaceutical regulations in the context of advertising. Main Pharmaceutical Inspector is the appeal institution in matters connected with executing tasks and competences of Pharmaceutical Inspection (the institution of second instance with regard to decisions of the provincial pharmaceutical inspector). Appeals against MPI’s decisions are filed before the Voivodeship Administrative Court (VAC) in Warsaw. Further appeal should be brought in the form of a cassation complaint with the Supreme Administrative Court (SAC).

An entity seeking to produce or import medicinal products must file an application for approval with the Inspectorate. The application must specify the medicinal name of the product and any other commonly used names (INN).

III. Names of medicinal products and trademarks
A trade mark under the Polish law can be any sign capable of being represented graphically, provided that such signs are capable of distinguishing the goods of one undertaking from those of other undertaking. The following, in particular, may be considered as trademarks: words, designs, ornaments, combinations of colours, the three-dimensional shape of goods or of their packaging, as well as melodies or other acoustic signals. Rights of protection will not be granted for signs which are a subject of absolute or relative grounds for refusal.

A medicinal product is defined as a substance or mixture of substances presented as having properties for treating or preventing disease in humans or animals, or given to make the diagnosis or to restoring, improving or modifying physiological functions through the pharmacological, immunological or metabolic effect. The the provisions of the PHL also apply to products that meet the criteria for both medicinal product and another type of product, in particular dietary supplement or cosmetic (as defined by separate regulations).

Pharmaceutical trade marks not only need to comply with the provisions of the IPL, but also need to meet the requirements regarding names of pharmaceutical products contained in the PHL. Pursuant to these regulations, a pharmaceutical name can be:

an invented name, as long as it does not cause confusion with a common name (i.e., an international non-proprietary name (INN) recommended by the World Health Organization or, if such name has not been attributed to a given product, a common chemical name) or
a common, or scientific name accompanied by a trademark, a company name or the name of the marketing authorization holder.

Obtaining an authorization for the release of a medicinal product under a given name does not exempt an entity from liability if the name violates third-party trademark rights. Applicants must therefore also keep in mind the provisions of the IPL and the CUC.

An announcement of the president of the ORMP issued on March 12 2008 gives further guidance on the process of naming medicinal products and the substitution of names that have already been granted. It sets out the following instructions:
– The new name of a medicinal product should differ from an earlier registered product name in at least three letters and the new name cannot include a sequence of more than two of the same letters. An applicant is required to provide a justified written statement when seeking a waiver from these rules.
– The new name cannot result in the likelihood of confusion (in print, spelling and pronunciation) with an earlier registered name.
– Signs such as ® and ™ cannot form part of the new name.
– The name of a medicinal product cannot contain personal names and surnames, including the name of the inventor. Further, it must not contain:
1. Names of abstract persons that are used together with scientific titles, aliases or pseudonyms.
2. Expressions which bring to mind religious, geographical or historical associations.
3. Names of natural objects.
4. Obscene words or words suggesting obscene content.
– The name of the medicinal product must also be placed on the packaging in the Braille system.

The evidence of registration of a medicinal product name with the ORMP can act as evidence of use of the sign as at that date when attempting to protect the name as an industrial property right.

IV. Parallel imports and repackaging
Parallel importation into Poland of a pharmaceutical product from other EU member states or members of the European Economic Area (EEA) is acceptable provided that it meets all of the following conditions:

The parallel-imported medicinal product must have the same active ingredient(s) as the product authorized for marketing in the territory of the Republic of Poland (i.e., the same indications at least up to the third level of the Anatomical Therapeutic Chemical (ATC) or the ATC veterinary.
The parallel-imported product must have the same strength and administration route as the authorized product, as well as the same or similar form. Slight differences in form cannot lead to any therapeutic differences between the products.
Where the product authorized for marketing in Poland is a brand name pharmaceutical, the parallel import must also be the brand name product. Similarly, where the authorized product is a generic, the parallel-imported pharmaceutical must also be a generic.

A parallel importation licence is available on application to the Polish Health Minister. The licence is issued on the basis of an assessment report prepared by the president of the ORMP. The application must include a sample of the packaging and the product information leaflets. A licence is granted for a period of five years.

According to article 21a(9) of the PHL, a parallel importer is allowed place the pharmaceutical product on the market in the Republic of Poland under:

the name used in Poland,
the name used in the EU/EEA member state of origin, or
the common name (INN) or scientific name together with the trademark or name of the parallel importer.

A parallel importer intending to put a medical product on the Polish market must inform the holder of the marketing authorization in Poland as to the expected date of entry onto the market at least 30 days before such date.

In order to place a product on the market, the parallel importer must alter the packaging thereof to adhere to local standards. The packaging must comply with that approved in the import licence. Polish authorities generally require the repackaging of parallel-imported medical products into new boxes that contain informational leaflets for patients in Polish. The informational leaflet must also be consistent with the parallel import licence.

The first parallel-imported medical products were placed on the Polish market in November 2005. As of the end of March 2008, over 200 parallel import licences had been granted in Poland.

The process of repackaging frequently causes disputes between parallel importers and mark owners. However, there is no case law in Poland with regard to this issue at present.

V. Anti-counterfeiting and enforcement
The responsibility for combating the trade and distribution of counterfeit medicines in Poland falls on the bodies responsible for the prosecution of crime – the Police, the Custom Service (detection and seizure of imported counterfeit medicines) and the Public Prosecutor’s Office. According to the official data published by the Ministry of Finance, 1,356 counterfeit packages of medicine were seized at the Polish borders in 2007, while 1,700 packages were seized within the first three months of 2008. According to the Main Pharmaceutical Inspectorate, 99% of medicines offered for sale from illegal sources are counterfeit and are hazardous to life or health.

VI. Advertising of pharmaceutical products
The PHL sets out the requirements for advertising pharmaceutical products in Poland. The advertising of medicinal product has also to be made in accordance with the current Regulation of the Minister of Health on the advertising of medicinal products of 21 November 2008, Journal of Laws (Dziennik Ustaw) No 210 item 1327. Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product, with the purpose of increasing the number of prescriptions, delivery, sale or consumption of the medicinal product.

Among others, the following activities are seen as advertising of pharmaceutical products:

Advertising of pharmaceutical products addressed to the public,
Advertising of pharmaceutical products addressed to individuals authorized to issue prescriptions or involved in the distribution of pharmaceutical products,
The visiting by sales or medical representatives of individuals authorized to issue prescriptions or involved in the distribution of pharmaceutical products,
The provision of pharmaceutical product samples,
Sponsoring promotional meetings for individuals authorized to issue prescriptions or involved in the distribution of pharmaceutical products
and
Sponsoring scientific conferences, meetings and congresses for individuals authorized to issue prescriptions or involved in the trade of pharmaceutical products.

It should note that the Polish legislature did not apply the correct legislative techniques and thus the PHL includes different concepts with different contents of which makes a mess of the legal terminology. It is also the problem of the European legislator because the same problem also applies to article 86 of the Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

Pharmaceutical products may be advertised exclusively by the parties responsible for the products or by persons who have been commissioned by such parties.

An advertisement for a pharmaceutical product cannot be misleading. It should present the product objectively and inform about its rational use. Further, the following types of advertising are prohibited:

Advertising offering or promising any advantages in a direct or indirect manner in return for purchasing the product, or providing any evidence of having purchased the product.
Advertising addressed to children or containing any element which might be considered as being addressed to children.
Advertising of pharmaceutical products that have not been admitted for trade in the territory of Poland or contain information which is inconsistent with the officially approved pharmaceutical product description.

Special restrictions are also imposed on advertising directed to specialists and the public.

VII. Generic substitution
Generic substitution is allowed under Polish law. Generic drug names comprise the name of the company producing the medicine together with its INN or invented name.

VIII. Online issues – e-pharmacies, domain names
The market turnover of medicinal products takes place only under the terms and conditions laid down by the PHL’s regulations. Conducting the sale of medicines is reserved for “public pharmacies”. In addition, the right of the retail resale of certain drugs without a prescription and some prescription drugs is granted to “pharmacy points”. The sale of selected drugs without a prescription can be also conducted by the so-called “out-pharmacy market post”: herbal-medical shops, specialized medical supplies stores, pet shops, herbal/chemists shops/drugstores, and public shops – provided that the staff have appropriate qualifications. The law precisely regulates all features that the public pharmacy should have and the pharmacy point. It already implies the existence of the physical premises open to the public and intended to pursue the sale of drugs. The PHL authorized public pharmacies and pharmacy points to conduct the mail-order sale for public only for medicines purchased without a prescription (article 68 (3) of the PHL). Additionally, the term “pharmacy” is a reserved name that is legally protected under the PHL and criminal law, as well as unfair competition regulations. Any entity wishing to use the term “pharmacy” must meet strict regulatory requirements. Online operators that do not meet the conditions set by the regulations on pharmacies can neither use the term “pharmacy” nor trade in pharmaceutical products.

Where a domain name including a trade mark has been registered by an unauthorized third party, the mark owner can use mediation, alternative dispute resolution (ADR) proceedings or civil court action to obtain the cancellation or transfer of such domain. However, following a recent judgement of the Polish Competition and Consumer Protection Court of 26 December 2006, case act signature XVII AmC 170/05, ADR is unlikely to succeed if the disputed domain name is registered in the name of a natural person.

Advertising of pharmaceuticals, case VI SA/Wa 1758/09

January 6th, 2010, Tomasz Rychlicki

The Polish court issued a first judgment regarding TV/radio sponsored programmes and advertising of pharmaceutical products. US Pharmacia Company prepared a TV spot that was aired with a TV show. The following statement appeared in the spot.

The programme is sponsored by the manufacturer of Apap Noc medicine. Apap Noc – now also available in the big package. Combats pain and helps you fall asleep.

According to the provisions of Article 17(1) of the Polish Act of 29 December 1992 on Broadcasting – LOB – (in Polish: Ustawa o radiofonii i telewizji), published in Journal of Law (Dziennik Ustaw) of 1993, No 7 item 34, consolidated text of 19 Novemver 2004, Journal of Laws (Dziennik Ustaw) No 253 item 2531, with subsequent amendments, sponsored programmes or other broadcasts shall be identified as such by sponsor credits at their beginning or end. Such credits may specify only the sponsor’s name, business name, trademark or contain some other identification of the business operator or its business activities, the image of a single product or service. According to the regulations provided in Article 4 pt. 7 of the LOB, the “sponsorship” should mean a direct or indirect financing or co-financing of the production or transmission of a programme or other broadcasts by an entity other than the broadcaster or producer of the programme, with a view to establishing, enhancing or promoting the renown of the name, business name, product or service, trademark.

The Polish Act of 6 September 2001 on Pharmaceutical Law – PHL – (in Polish: ustawa prawo farmaceutyczne), published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with subsequent amendments, does not include provisions relating to sponsorship of programs or other broadcasts in radio and television. The Main Pharmaceutical Inspector (MPI) is the central organ of public administration authorized to ensure compliance with pharmaceutical regulations in the context of advertising. According to MPI many pharmaceutical companies are trying to skip the strict sponsorship rules for advertising of pharmaceutical/medicinal products. MPI has already delivered several decisions requiring pharmaceutical companies to immediately cease advertising of medicines, and only US Pharmacia appealed this decision to the Voivodeship Administrative Court. The company argued that the spot was aimed at enhancing the reputation of the medicinal product. The MPI argued that it is unacceptable to add any other indications relating to both the sponsor and the subject of its activities, in particular the goods and services. Such behaviour turns sponsorship into advertising activity.

The Voivodeship Administrative Court in its judgment of 18 December 2009 case file VI SA/Wa 1758/09 ruled that the sponsorship cannot be used as unacceptable advertisement. It has to be a form of promotion separated from advertising. The content and meaning of communication and the message broadcasted decides whether we are dealing with advertising or with corporate sponsorships. The Court also emphasized that each advertising of medicinal product has to be made in accordance with the current Regulation of the Minister of Health of 21 November 2008 on the advertising of medicinal products, published in Journal of Laws (Dziennik Ustaw) No 210 item 1327. The advertising of a medicinal product targeted to the public must contain the following essential information:

the name of the medicinal product
the INN of the active substanc, in the case of medicinal products containing more than 3 active substances, the term “complex product”
the dose of the active substance or active substance concentrations, with the exception of a complex product
pharmaceutical form of the product
indication or indications for therapeutic use
contra-indications
identification of the responsible entity

The advertising of medicinal product targeted to the public that is made in the audio-visual form additionally has to contain a warning of the following content:

Before use read the leaflet included in the package or consult with your doctor or pharmacist, as each drug that was used improperly may threaten your life or health.

This warning shall be placed in the bottom of the ad, in terms of representing not less than 20% of its surface, so as to make the text stand out from the background plane visible, legible, motionless, placed horizontally, the distance of letters from the top and bottom edge of the background plane ad cannot be bigger than 1/2 in height and the distance between the lines of the string cannot be bigger than the height of the letters. This warning must be read clearly in the Polish language and it has to appear on the screen no less than 8 seconds. The same rules regarding the warning apply to the advertising of a medicinal product targeted to the public that was prepared as a sound message.
Advertising product targeted to the public in a static visual form, shall contain a warning stating:

Before use read the label, which includes indications, contra-indications, data on adverse effects and dosage and information about the medicinal product, or consult a doctor or pharmacist, as each drug used improperly threatening your life or health.

The Warning shall be placed in the bottom of the ad, in terms of representing not less than 10% of its surface in such a way as to make the text stand out from the background plane visible, legible, motionless, placed horizontally, the distance of letters from the top and bottom edges of the background plane of the ad cannot be bigger than 1/2 in height and the distance between lines of the inscription cannot be bigger than the height of the letters. In the case of advertising to the public in a visual form which includes more than one page, a warning has to be placed on the first page.

Advertising of pharmaceuticals, case II CSK 289/07

May 7th, 2009, Tomasz Rychlicki

This case is a little bit old but I think it’s really worth mentioning to P.T. readers. The Supreme Court of the Republic of Poland decided a case regarding misleading advertising of pharmacetical products. The Court in its judgment of 2 October 2007, case act signature II CSK 289/07 ruled that assessment whether advertising can be deemed as misleading should refer to the model of the average recipient of this kind of advertising – the consumer of advertised products or services.

In this case, it was the average consumer of pharmaceuticals, to which advertising newspapers and leaflets were directed. As the Supreme Court noted in its judgment of 3 December 2003, case act signature I CK 358/02, the model of the average consumer, who is reasonably well informed and reasonably observant and circumspect, is now used widely adopted in the Republic of Poland as it is in the European Union.

However, the model of an average consumer could not be defined and considered in isolation from the conditions of this specific case and the realities concerning recipients of specific products to which the advertising is directed. Therefore, one could not ignore the fact that such consumers are often very ill persons, often with reduced capacity of perception and limited ability of reasonable and critical evaluation, as well as they are often elderly, which is also a significant group of consumers of medicines. These are typically the person more susceptible to suggestion and less critical. These people are targeted by pharmaceutical advertising and, while assessing the possibility of confusion, the characteristics of this kind of audience should be taken into account as a model of the average consumer.

Polish case law on advertising of pharmaceuticals

February 1st, 2009, Tomasz Rychlicki

Below you will find a list of judgments and decisions on advertising of pharmaceuticals. You can find a more detailed discussion on each judgment or decision under the link provided with the case file. All judgments and decisions are given in chronological order.

– The judgment of the Voivodeship Administrative Court in Warsaw case file VI SA/ Wa 1136/10.

– The decision of the the Main Pharmaceutical Inspector of 10 March 2010, no. GIF-P-R-450/141-4/ZW/09/10.

– The decision of the the Main Pharmaceutical Inspector of 4 March 2010, no. GIF-P-R-450/147-3/ZW/09/10.

– The decision of the the Main Pharmaceutical Inspector of 6 January 2010, no GIF-P-R-450/126-3/ZW/09/10.

– The judgment of the Voivodeship Administrative Court in Warsaw of 11 March 2010, case file VI SA/Wa 2110/09.

– The judgment of the Supreme Administrative Court of 10 March 2010, case file II GSK 461/09.

– The judgment of the Voivodeship Administrative Court in Warsaw of 18 December 2009, case file VI SA/Wa 1758/09.

– The judgment of the Supreme Administrative Court of 26 June 2008, case file II GSK 199/08.

– The judgment of the Voivodeship Administrative Court in Warsaw of 17 June 2008, case file VII SA/Wa 556/08. This judgment is not yet final. A cassation complaint may be filed to the Supreme Administrative Court.

– The judgment of the Voivodeship Administrative Court in Warsaw of 3 October 2007 case file VII SA/Wa 1157/07.

– The judgment of the Voivodeship Administrative Court in Warsaw of 29 December 2005 case file I SA/Wa 584/05.

– The judgment of the of the Supreme Court – Civil Chamber of 2 October 2007, case file II CSK 289/07, published in the Jurisprudence of the Supreme Court, the Civil Chamber (in Polish: Orzecznictwo Sądu Najwyższego Izba Cywilna) of 2008, No 12, item 140, p. 54.

Advertising of pharmaceuticals, case II CSK 289/07

January 24th, 2009, Tomasz Rychlicki

According to one of the older judgments of the of the Supreme Court – Civil Chamber of 2 October 2007, case file II CSK 289/07, published in the Jurisprudence of the Supreme Court, the Civil Chamber (in Polish: Orzecznictwo Sądu Najwyższego Izba Cywilna) of 2008, No 12, item 140, p. 54, a public advertisement of promotional prices (price cuts) of drugs that is made by comparing these reduced prices with the higher prices, suggesting periodic drug sales at a lower price, is a prohibited public advertising of medicines as referred to in article 57(1)(i) and (iii) of the Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo farmaceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with subsequent amendments.

1. Advertising of the following medicinal products, addressed to the general public, shall be prohibited:
i) dispensed exclusively on doctor’s prescription
(…)
iii) included, according to separate regulations, on the lists of the reimbursable medicines and authorized for issuing without prescription, with the proper name identical with the name mentioned on these lists.

It is also the act of unfair competition as provided in article 16(1)(i) of the Act of 16 April 1993 on Combating Unfair Competition – CUC – (in Polish: ustawa o zwalczaniu nieuczciwej konkurencji), Journal of Laws (Dziennik Ustaw) No 47, item 211, with subsequent amendments.

In the field of advertising the act of unfair competition shall be, in particular, the following:
1) advertising contrary to provisions of the law, good practices or offending human dignity,

The Court ruled that assessment whether advertising can be deemed as misleading should refer to the model of the average recipient of this kind of advertising – the consumer of advertised products or services.

In this case, it was the average consumer of pharmaceuticals, to which advertising newspapers and leaflets were directed. As the Supreme Court noted in its judgment of 3 December 2003, case file I CK 358/02, the model of the average consumer, who is reasonably well informed and reasonably observant and circumspect, is now used widely adopted in the Republic of Poland as it is in the European Union.

Advertising law, new rules for pharmaceutical products

September 7th, 2008, Tomasz Rychlicki

In the article entitled “Przybędzie zakazów w reklamach leków“, the Polish newspaper Rzeczpospolita reports a recent legislative initiative regarding a draft regulation on advertising of medicinal products prepared by the Polish Ministry of Health. Monitors displaying ads may disappear from pharmacies. Advertising of any medicines will not be allowed in hospitals or pharmacies. The proposed draft especially concerns audio and audiovisual advertising. A similar ban exists in the current Regulation of the Minister of Health of 16 December 2002 on the advertising of medicinal products, Journal of Laws (Dziennik Ustaw) of 2002 No. 230, item 1936, however, it allows for advertising contained in radio and television programmes. There were assembled special monitors to broadcast TV spots in some pharmacies. Such exceptions will no longer be allowed , and the display of medicine advertising spots will become illegal.

The proposal also includes the types of advertising of medicinal products: i.e. advertising which is targeted to the general public or persons who are entitled to issue medical prescriptions or persons engaged in the marketing of medicinal products. The Ministry of Health has stresses that such specification will clearly defined market rules and will have a positive effects on fair competition.

Advertising in visual form must contain a warning.

Before use, read the label, which includes indications, contra-indications, data on side effects, dosage and information about the medicinal use of the product, or consult your doctor or pharmacist.

The warning has to be included in any part of advertising, on a flat surface which is not less than 10 percent of total surface area of the ad. The text must be distinguished from the background and it be legible. A warning in an audiovisual advertising has to be placed in the lower parts of the plane, which is not less than 20 percent of the total surface area. It must also be clearly legible in the Polish language and appear on the screen for not less than 5 seconds.

Advertising of pharmaceuticals, case II GSK 199/08

June 30th, 2008, Tomasz Rychlicki

Apteka przy Ratuszu – Centrum Farmaceutyczne (the pharmacy) in Białystok had published a brochure titled “Megaextracharges” (Megadopłaty) in which it has provided information about promotional prices of medicinal products that were available in “Apteka przy Ratuszu”. The Main Pharmaceutical Inspector (MPI) – the central organ of the Polish administration which has the authorithy to supervise compliance with the regulations of Pharmaceutical Law in the scope of advertisements – has ruled that such advertising is prohibited by the Polish Pharmaceutical Law and has ordered the owners of the pharmacy to cease distribiution of brochures and leaflets.

Article 52 of the Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa prawo farmaceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2008, No 45, item 271, with later amendments provides definition of advertising.

Advertising a medicinal product shall mean any activity consisting in informing about and encouraging to use the medicinal product

Article 53(1-2) of the PHL allows for limited advertising.

1. Advertising of a medicinal product must not be misleading, it shall show the medicinal product objectively and it shall inform about its rational application.

2. Advertising of a medicinal product can not consist of offering or promising of any benefits, in direct or indirect way, in exchange for product’s purchase or delivery of proofs that the product was purchased.

The owners filled a complaint before the Voivodeship Administrative Court (VAC) in Warsaw. The Court overruled the MPI’s decision and held that the disputed brochures provided information only about the possibility to buy cheap medicines which, in consequence, did not fulfil the definition of “advertising of a medicinal product” as provided in Article 52 of the PPL. The VAC did not find any circumstances of “encouragement to buy” in those promotional materials.

The MPI filled a cassation complaint before the Supreme Administrative Court. The SAC agreed with the Main Pharmaceutical Inspector and held that the lower court should assess not only the visual incentive to buy, but also the “actual intention”, while testing the differences between information and advertising.

The Supreme Administrative Court in a judgment of of 26 June 2008, case file II GSK 199/08 clearly noted that prices promotions encouraging to medicinal products purchases in a specific pharmacy are the advertising of a medicinal product and a company which applies it.

Advertising of pharmaceuticals, case VII SA/Wa 556/08

June 19th, 2008, Tomasz Rychlicki

US Pharmacia has commissioned a TV spot for Stoperan – a diarrhoea drug. The ad’s message promised an immediate effect and cure. The Main Pharmaceutical Inspector – the central organ of the Polish administration which has an authorithy to supervise compliance with the regulations of Pharmaceutical Law in the scope of advertisement, has ruled that this advertising spot was contrary to the charactersitics of the drug, because Stoperan works in 1-3 hours and achieves a therapeutic effect after 48-72 hours. In short, it does not cure, though it overcomes the cause.

US Pharmacia has appealed against the MPI’s decision, claiming that it has ceased the broadcasting and screening of the contested ads. The new version had the questioned parts removed and replaced by other to which the MPI did not submit any objections.

However, the Voivodeship Administrative Court has ruled that the MPI had the right to order the cessation of a medicinal product’s advertisement where it was contrary to the current legal regulations and US Pharmacia has violated the provisions of article 55 and 56 of the Polish Act on Pharmaceutical Law – PHL – (in Polish: ustawa Prawo farmaceutyczne) of 6 September 2001, published in Journal of Laws (Dziennik Ustaw) of 2004 No. 53, item 533, with later amendments.

Article 55
Advertisements of medicinal products should not be misleading, should objectively present a medicinal product and inform of its rational application.
(…)
Advertisements of a medicinal product addressed to the general public also cannot include any contents that would:
(…) assure that taking a given medicine guarantees an appropriate effect, it is not accompanied by any undesirable effects or that effect is better or the same as in the case of another method of treatment or treatment with the use of another medicinal product;
(…)
Article 56
It shall be prohibited to advertise medicinal products:
1) not authorized to turnover on the territory of the Republic of Poland;
2) containing information inconsistent with the approved Characteristics of the Medicinal Product.

The judgment of the Voivodeship Administrative Court in Warsaw of 17 June 2008, case file VII SA/Wa 556/08 is not final. The parties have a right to file a cassation complaint to the Supreme Administrative Court.

Advertising of pharmaceuticals, case VII SA/Wa 1157/07

December 7th, 2007, Tomasz Rychlicki

The Voivodeship Administrative Court in Warsaw in its judgment of 3 October 2007 case file VII SA/Wa 1157/07 held that a given activity is deemed as the advertising of pharmaceutical product, if it involves the transfer of information on the product while encouraging its use – i.e., it must be information describing the medicinal product in a way to encourage its use, information that is passed to increase the number of prescriptions, the supply of pharmaceutical product or its sale or consumption.

Advertising of pharmaceuticals, case I SA/Wa 584/05

February 7th, 2006, Tomasz Rychlicki

The Voivodeship Administrative Court in Warsaw in its judgment of 29 December 2005 case file I SA/Wa 584/05 held that the important element of pharmaceutical product advertising is the intention of the advertiser to cause a specific reaction of potential customers. Therefore any activity, regardless of its specific, individual way and method of its performance and measures used for its implementation should be considered as the advertising of a medicinal product if the goal of this activity is to increase sales of the advertised product.

Categories: Art. 55 PHL | Main Pharmaceutical Inspector | pharmaceutical products advertising | Voivodeship Administrative Court.