NEWSLETTER Information on pharmaceutical and medical law

Transcription

1 NEWSLETTER Information on pharmaceutical and medical law No. 42 DECEMBER /1/2015 NEWS Legislative summary In this year s September and November issues we brought you information on legislative proposals discussed in the Chamber of Deputies and the Senate during their autumn sessions. Now, after three months we bring you latest information of the aforementioned presses and other proposals. We also categorize the presses on the basis of governed area as usual. a) public health insurance A proposal for amendment of the Act no. 48/1997 Coll., on public health insurance, discussed as press no. 307, which aims to react to a decision of the Constitutional Court file no. 43/13 from 25 th March 2014, cancelling a decree governing Indication list for spa care, has been passed by the Chamber of Deputies and assigned to the Senate. However, the Senate returned the press back to the Chamber of Deputies on 10 th December with its own amendatory proposals. These proposals consist in cancellation of first two articles of the amendment, as a result of which health insurance companies would not be obliged to publish individual reimbursement agreements with health care providers. After acceptation of the proposal of the upper chamber by the Chamber of Deputies, the amendment was published in the Collection of Laws as an Act no. 1/2015. Press no. 126, i.e. a communist proposal for amendment of the Act on public health insurance consisting in cancellation of all regulatory fees and establishment of an annual limit for additional charges paid for medicinal products and food for special medical use of CZK 2,500 per year, has not been discussed in the first reading yet and concerning legislative priorities of the government it will probably not be discussed even in close future. b) pharmaceuticals On 6 th November 2014 the President signed a proposal for amendment of the Act no. 387/2007 Coll., on pharmaceuticals, discussed as a press no. 259, which aims to remain a possibility of written prescription of medicinal products (together with electronic version) up to 1 st January This amendment was published in the Collection of Laws as an Act no. 255/2014 Coll. To the contrary, the press no. 269 that governs one-time transfer of CZK 1,700,000,000 from an account of the State Institute for Drug Control to account of the Czech Republic, has been only passed the first reading so far and the Health Committee recommended its approval. Advokátní kancelář Marečková, Křenova 7/438, Praha 6, tel.: , info@mareckova.cz,

2 c) medical devices As we have already informed you, the proposal of a new Act on medical devices was signed by the President on 6 th November 2014 and published in the Collection of Laws on 24 th November 2014 as an Act no. 268/2014 Coll., which comes into effect on 1 st April d) VAT A proposal for amendment of the Act no. 235/2004 Coll., on value added tax, we informed you of in the last issue (press no. 291) was returned to the Chamber of Deputies on 10 th December 2014 with amendatory proposals. They concern especially time limits for submission of so called control reports, nonetheless they do not change substance of this institute. The approved amendment is effective from 1 st January e) social services A proposal for amendment of the Act no. 108/2006 Coll., on social services, discussed as press no. 257, was signed by the President on 6 th November 2014 and published in the Collection of laws on 19 th November 2014 as an Act no. 254/2014 Coll. The amendment aims to govern financing of social services in connection to transfer of competencies to regions and related changes. To the contrary, a proposal of governmental opposition regulating the same issue, discussed as a press no. 205, was withdrawn before the first reading. f) public procurement Press no. 300, i.e. a proposal for amendment of the Act no. 137/2006 Coll., on public procurement, was approved by the Chamber of Deputies and passed to the Senate on 12 th December 2014 (we wrote more about its content in September issue). The SAC confirmed a high fine for repeated breach of the Act on Advertising Regulation The Supreme Administrative Court issued a decision file no. 8 As 34/2013 on 20 th October 2014, by which it refused a complaint of a contractor against a decision of the Municipal Court in Prague that confirmed a fine of CZK 1,100,000 for breach of s. 5d subs 2 par. d) of the Act no. 40/1995 Coll., on Advertising Regulation, as amended (referred to as ARA ). The cited provision prohibits assignation or signalling characteristics of prevention or treatment human of human diseases to food. The complainer should have breached it by ordering of a teleshopping promoting an articular food supplement on TV Nova the respective product was described as a preparation with anti-inflammatory and partially structural effects, containing slowly absorbed substances with anti-inflammatory effect, effectiveness of which is mentioned in many scientific studies (we brought you more information on this case in June 2013). Decision of the Municipal Court in Prague was consequently challenged by a complaint. The Supreme Administrative Court decided on it and expressed following generally applicable conclusions:

3 a) A proposal for moderation of a fine does not have to be settled by a separated verdict The complainer challenged the decision of the Municipal Court inter alia for its said unverifiability, which was found in missing verdict on his proposal for moderation of amount of the imposed fine (the complainer had proposed to the Municipal Court cancellation or at least decrease of the fine imposed by the Council for Radio and Television Broadcasting). The Municipal Court confirmed the fine but it did not decide on the proposal for moderation of the fine by a separate verdict, which should have (in opinion of the complainer) constituted a substantial imperfection of the whole decision. However, the Supreme Administrative Court disagreed with this argument and referred to its previous judicature (e.g. decision file no. 3 As 6/ ), in which it thoroughly described process of making decision on a proposal for fine moderation. It stated that in case that the court supposes that the challenged administrative decision is legal and the imposed fine is not evidently inadequate, the court shall reject the action as a whole (i.e. all proposals given in petit of the action) by one verdict ( The action is rejected. ). These conditions were fulfilled by the Municipal Court in described case since it also commented on reasons for confirmation of the amount of imposed fine on two pages of the decision. b) Even presentation of true information may be sanctioned under the ARA The Supreme Administrative Court also repeatedly concluded that an ordering party is naturally entitled to publish true information on characteristic of promoted products, but also (and especially) obliged to inform consumers of the fact that the respective product is only a food supplement, not a medicinal product. In the beginning of the teleshopping in question it was clearly communicated to watchers that the promoted product is a food supplement. Regardless of this fact the Supreme Administrative Court concluded that the sanction was imposed duly, which was caused by additional information presented during the spot and the way of their presentation. It was basically found as an aggravating factor that the product was promoted by a diet advisor who described its content and effects of its substances in detail by way resembling advertisements of medicinal products. It was not even concerned as mitigating factor that the product was not promoted directly by a doctor or a pharmacist but only a diet advisor because the court stated that the overall impression from the commercial prevailed. It was also proved that used health claims are not registered in the list of health claims under Regulation no. 1924/2006. This sole fact causes that their usage is prohibited, regardless of their claimed (or even proved) verity. c) Repeated breach of the ARA may lead to significant increase of imposed sanctions The complainer also claimed that the amount of imposed fine, i.e. CZK 1,100,000 inadequately exceeds fines that had been imposed to him in similar cases. The Supreme Administrative Court noted that administrative discretion was applied in compliance with law since the Council imposed a fine at a half of permissible range because the previous sanctions evidently had not motivated the complainer to avoid further breaching of law.

4 d) Arguments for imposition of a lower fine must by presented during proceedings on administrative action at latest The complainer submitted a media analysis of a number of watchers of the respective teleshopping because the amount of imposed fine was reasoned inter alia by the fact that TV Nova persistently reaches the highest numbers of watchers and its commercials may therefore address more people. To the contrary, the media analysis submitted by the complainer suggests that a number of watchers of the respective teleshopping was substantially lower than in case of average commercials. Nonetheless, the Supreme Administrative Court could not take this objection into account, referring to s. 109 subs. 5 of the Act no. 150/2002 Coll., the Code of Administrative Justice, as amended, that does not enable to take into account the facts submitted after issuance of the challenged decision. Regarding that the complainer ordered the analysis only after issuance of the decision of the Municipal Court and did not propose it as evidence in process before the Municipal Court, the Supreme Administrative Court could not take it into account, although it could theoretically have (if applied in time) reasoned at least decrease of the imposed sanction. The Court of Justice of EU on abuse of a dominant position of a patent holder Advocate General of the Court of Justice of the European Union issued an opinion in case file no. C-170/13 on 20 th November 2014, regarding abuse of a dominant position of a patent holder. The mentioned case concerned a patent for standardized technology from the area of telecommunications, whose holder gave a commitment to the European Telecommunications Standards Institute to grant licences to third parties on fair, reasonable and non-discriminatory terms (hereinafter referred to as FRAND terms ). Regarding that the patent holder did not conclude on licence conditions with its competitor and this company continued using the patented technology, the holder decided to bring an action in order to obtain an injunction prohibiting the continuation of the infringement and an order for the rendering of accounts, the recall of products and compensation of damages. The proceedings before the Court of Justice were consequently held upon a question, whether bringing of such an action does not constitute abuse of a dominant position of a patent holder. This question arose during proceedings before a German court since if a patent holder succeeded with his action against its competitors, it could inter alia achieve recall of their products from the market and therefore exclude any competition in the respective area. After studying of file documentation, the Advocate General concluded that a sole fact that a patent holder brings an action on the basis of art. 10 and 11 of Direction no. 2004/48/EC on the enforcement of intellectual property rights, constitutes abuse of a dominant position under art. 102 of the Treaty of Functioning of the European Union, on condition it is proved that the respective patent holder did not comply with its commitment to conclude a licensing agreement under FRAND terms with a third party even though it has shown itself to be objectively ready, willing and able to conclude such a licensing agreement. However, in connection to this conclusion of the Advocate General there arose other questions, especially how a patent holder may avoid abuse of

5 its dominant position and how should be objectively assessed readiness of a third party to conclude a licensing agreement. The Advocate General proposes this process: He supposes that a patent holder must firstly (before bringing an action) inform the third party in writing that its conduct breaches the law a support its claim with satisfactory evidence, i.e. especially by determination the concrete patent that is supposed to be breached and specification of the way of its breaching. At the same time the patent holder has to submit a written offer for conclusion of a licensing agreement under FRAND conditions that must contain all the terms normally included in a licence in the sector in question, in particular the precise amount of the royalty and the way in which that amount is calculated. The said infringer is then obliged to react to the submitted offer duly and properly. In case that it does not agree with it, it is obliged to submit its counteroffer without delay. However, in order to avoid pure obstruction, the making of a request for corrective measures or the bringing of an action for a prohibitory injunction does not constitute an abuse of a dominant position if the infringer s conduct is purely tactical and/or dilatory and/or not serious (although we suppose that provability of this fact is highly disputable in real). On the other hand, the Advocate General states that patent infringers are entitled to demand determination of FRAND conditions, under which the agreement should be concluded, before the court, whereas such conduct cannot be interpreted as dilatory. However, it does not prevent the patent holder from legitimate requiring a bank guarantee for the payment of royalties or deposition of a provisional sum at the court or arbitration tribunal in respect of past and future use of the patent by the infringer. Conduct of a patent infringer also may not be assessed as dilatory or obstructive if it reserves the right, after concluding an agreement for a licence, to challenge before a court or arbitration tribunal the validity of the respective patent. Nonetheless, unlike bringing an action for recall of competing products, the Advocate General concluded that if a patent holder takes legal action only to secure the rendering of accounts or compensation of damages, its conduct as such does not constitute an abuse of a dominant position. The described conclusions of the Advocate General are (on condition of their acceptance by the respective senate of the Court of Justice that is not legally bound by opinions of advocates) generally applicable even to patents from other areas than telecommunications (e.g. medicinal products) since they are based on general Union regulations, i.e. the Charter of Fundamental Rights of the EU, Treaty of Functioning of the EU and Direction on the enforcement of intellectual property rights. ECHR on home births in the Czech Republic The European Court for Human Rights issued two decisions concerning realization of home and ambulant births in the Czech Republic on 11 th December The first case was held upon complaints of two Czech mothers, no /11 and 08473/12 (Dubska and Krejzova v. Czech Republic), who, after previous experience with births in 2011 and 2012, decided to give birth at home with assistance of a midwife. The first of complainers decided for this solution after previous negative experience with birth in a

6 hospital where she had been urged to undergo various medical interventions against her wishes and had been ordered to stay in hospital longer than she wished. To the contrary, the second complainer made this choice after two previous successful home births with assistance of a midwife. However, in the respective years it was not legally possible to give birth at home with assistance of a midwife since the Czech law order prohibits midwifes to provide health services during births. It implies that their potential attendance in spite of this prohibition cannot be reimbursed from public health insurance at least similarly to births realized in hospitals. The state of fact described above, when mothers to be who wish to give birth with assistance of professionals do not have another choice than to come to hospitals, should have breached the complainers rights to respect for private and family life guaranteed by art. 8 of the European Charter of Human Rights and Fundamental Freedoms. The Court stated that their rights had been really touched, especially because of broad understanding of art. 8, which encompasses right to personal autonomy and physical and psychological integrity. The Court admitted that the interference was based on law regarding the fact that the complainer were able to envisage that assistance of a doctor at home birth was not allowed. Nonetheless, the Court considered the reasons for the described restrictions as justifiable because the existing law aims to protect especially life and health of a newborn during birth and indirectly also life and health of mothers. The Court also noted that the area of home births has not been unified in particular member states yet. The court also conceded that the most of scientific studies focused on security of home births state that under some basic conditions home births do not present increased risk compared to births in hospitals. Such conditions especially expect home births are realized only in case of lowrisk pregnancies and that midwifes are present to them. The situation in the Czech Republic, where medical professionals were not allowed to assist mothers giving birth at home and where there was no special emergency aid available, actually increased the risk to the life and health of mother and newborn. To the contrary, the Court considered argument of the Czech government that even if a pregnancy seemed to be without any particular complications, there could be unexpected difficulties requiring specialised medical interventions only available in a hospital. In this light, the Court concluded that the mothers concerned, including the applicants, did not have to bear a disproportionate and excessive burden and that art. 8 of the Charter was not breached. However, the Court also stressed that Czech authorities should keep the relevant provisions under a constant review, taking into account medical, scientific and legal developments. The Ministry of Health has commented this decision only in general so far and preserved unspecified time limit for its study. The second Czech case concerns complaint no /10 (Hanzelkovi v. Czech Republic), which was also brought in order to obtain a decision confirming breach of art. 8 and art. 13 of the Charter, which guarantees right to an effective remedy. Right to respect to private and family life should have been breached in this case because the complainer was unwillingly made to return to a hospital with a newborn shortly after they arrived home and stay there for 2 more days. The complainer firstly gave birth to her son and then, as there had been no complications, decided of her own accord to leave hospital that same day, in spite of the medical team s opposition. The hospital employees

7 immediately informed the police and social welfare authority since they could not physically prevent her from leaving. The social welfare authority consequently asked the District Court to adopt an interim measure with a view to entrusting the child to the care of the hospital s gynaecologyobstetrics department. The court accepted the request concerning the alleged short period of time since the birth, the health and potentially the very life of the child will be at risk if it is deprived of hospital care. A bailiff and a social worker accompanied by police officers went to the applicants house. A medical team was also summoned and a doctor examined the child. He observed that the child had no health problems. He agreed, however, with those concerned that for the purpose of implementing the interim measure, mother and child would be taken back to the hospital. The complainer then naturally tried to achieve cancellation of the respective interim measure. All of her proposals were nonetheless denied with reasoning that the interim measure has been already consumed by its realization, ceased to exist and cannot be cancelled. The Czech courts thus suppose that the complainer should have applied for cancellation of the interim measure during her enforced stay in hospital at latest and if she did so afterwards, it was too late (sic!). Later the courts even denied all of complainer s applications for apology and compensations, referring to the fact that the decision (interim measure) in question had not been cancelled. In this case the Court unsurprisingly concluded that the Czech Republic breached the complainer s right to an effective remedy. We shall bring you more information after publication of full versions of the decisions.