6.  The applicants are journalists. At the relevant time they were employed by one of the two national television stations in Denmark, Danmarks Radio, hereafter “DR”. The first applicant produced a television programme, described as a documentary, called “When the doctor knows best”, which was broadcast at 8 p.m. on 24 September 2008, and seen by 534,000 viewers. The second applicant was the first applicant’s superior and responsible for the content of the programme.
7.  The television programme concerned the treatment of pleural mesothelioma cancer, notably at Copenhagen University Hospital (Rigshospitalet), where Consultant S was in charge of treatment. It focused on two types of chemotherapy medication, Alimta, produced by L, and Vinorelbine, produced by F. Copenhagen University Hospital and S used Vinorelbine as first-line treatment in combination with Cisplatin or Carboplatin, depending on whether the treatment was related to an operation (operable patients) or to prolonging life and relieving pain and symptoms (inoperable patients).
8.  Three experts participated in the programme: a medical doctor from Karolinska Hospital in Sweden, a professor from Switzerland and a medical doctor from Grosshandorf Hospital in Germany. They all used Alimta as first-line treatment, most often in combination with Cisplatin or Carboplatin. The programme followed four patients and their relatives, who told their stories, and a narrator spoke as a voice-over throughout the programme.
9.  In preparation for the programme, the first applicant had carried out research on the subject which included, inter alia, the following.
10.  On 20 September 2004 the European Union had approved the marketing of Alimta in combination with Cisplatin for treatment of patients with inoperable pleural mesothelioma cancer. The background for the approval was, among others, research which had been carried out examining the effect of treatment with Alimta in combination with Cisplatin as compared to treatment with Cisplatin alone (a phase III trial, see paragraph 14 below) as first-line therapy.
11.  In July 2007 the Minister for Internal Affairs and Health replied to various questions posed by Members of Parliament as to the treatment of pleural mesothelioma cancer in Denmark. The Minister replied, inter alia, that there was no proof that an Alimta-based treatment was more efficient than other chemotherapy-based treatments, including that offered in Denmark; that the combination of Vinorelbine and Cisplatin, which was used at Copenhagen University Hospital, resulted in a one-year survival rate of 50% and a median lifetime of 12 months, which was exactly the survival rate from using the combination of Alimta and Cisplatin, but that there had been no direct comparison of the two treatments; and that there was no internationally accepted standard chemotherapy for the treatment of pleural mesothelioma cancer, but that several single and combined treatments were used.
12.  On 11 June 2008 Copenhagen University Hospital produced a memorandum about pleural mesothelioma cancer and its treatment, which was sent to DR. It stressed that international studies, including of Vinorelbine and Alimta, had not shown that any two-combination regime was superior to other two‑combination regimes. That information was confirmed by the professor from Switzerland in an email of 25 June 2008 and by the medical doctor from Grosshandorf Hospital in Germany in an email of 27 June 2008. The memorandum also referred to a fund aimed at developing research on pleural mesothelioma cancer, in the amount of 90,000 Danish kroner (DKK), equal to approximately 12,000 Euros (EUR), received by S from company F, which produces Vinorelbine. The money had been used to pay nurses and students and for data collection. It emerged that there had been no financial profit for the doctors involved.
13.  Having received the above-mentioned memorandum, the first applicant again contacted the professor from Switzerland and the medical doctor at Grosshandorf Hospital in Germany. In essence, they confirmed in subsequent emails of 2 and 21 July 2008 that since there had been no direct comparative clinical studies, there was no scientific evidence that one two‑combination regime was superior to another two-combination regime.
14.  Medical research studies involving human subjects are called clinical trials. They are divided into different stages, called phases. Generally, it can be said that the earliest phase trials may look at whether a drug is safe or at its side-effects. A later phase II trial aims to find out whether the treatment works well enough, for which types of cancer the treatment works, more about side effects and how to manage them and more about the best dose to use. A later phase III trial aims to test whether a new treatment is better than existing treatments (standard treatment). These trials may compare a completely new treatment with the standard treatment or with different doses or ways of giving a standard treatment.
15.  Subsequent to the broadcast on 24 September 2008 of the television programme, on 27 October 2008 Copenhagen University Hospital and S instituted defamation proceedings before the Copenhagen City Court (Københavns Byret) against the Director of DR and the two applicants, maintaining that the latter, in the programme in question, had made direct and indirect accusations, covered by Article 267 of the Penal Code (Straffeloven), against Copenhagen University Hospital and S, of malpractice regarding certain patients suffering from pleural mesothelioma cancer, allegedly resulting in the patients’ unnecessary death and shortening of life, in the interest of S’s professional prestige and private finances.
16.  Before the City Court, the applicants, S, and Medical Director H for Copenhagen University Hospital gave evidence.
17.  The first applicant stated, inter alia:
“... that she had not criticised Copenhagen University Hospital for improper treatment causing death. Her message was only to point out that the substance of Alimta had been better documented than the substance of Vinorelbine. She had collected statements from patients and experts, but could not state herself whether Alimta was a better product than Vinorelbine ... The experts had not stated whether Alimta in combination with another product was better than Vinorelbine in combination with another product. However, all experts had emphasised that Alimta had been evaluated in a phase III trial, for which reason it was a more thoroughly tested product. ... her questions had been answered during her conversations with professor M on 19 October 2007 and S on 22 October 2007. Subsequently no one had been willing to answer her questions. That was the only real conversation she had had with S. The next time she had called him, he had put down the receiver. When it had not been possible for her to get any response to her many points of criticism, she had contacted H ... she had wanted statements from both H and S as the programme would be unbalanced if they were not heard ... Some found that Alimta had been better documented than Vinorelbine. She was not aware of any trial demonstrating that a combination with Alimta was better than a combination with another medicinal product ...”.
S stated, inter alia, the following:
“Alimta has been used for second-line therapy in Denmark since 2004, and since 2007 as first-line therapy. Patients had been given the impression in the media that Alimta was a miracle cure. Therefore Copenhagen University Hospital had introduced it as an option. Today, Alimta is used in combination with Carboplatin as the standard therapy for inoperable patients ... Sometimes in autumn 2008, the standard therapy for operable patients had been changed to Cisplatin in combination with Alimta. If some patients were offered Alimta everybody had to be offered Alimta ... After the programme had been broadcast ... patients started mistrusting the Vinorelbine therapy. Afterwards it was not possible to perform the trial [phase II] on this drug. Nor would it be possible to obtain funding for the trial. Therefore no trial had been performed of Vinorelbine ... he had provided the information included in professor M’s memorandum of 23 September 2008 ...he had talked to [the first applicant] several times and had spent a lot of time and energy on explaining cancer therapy... he had also lost confidence in [the first applicant]...”
H stated, among other things:
“ ...The approval of Alimta by the Danish Medicines Agency for the treatment of mesothelioma only means that a marketing authorisation has been granted for the drug, which means that advertisement of the product is permitted. Vinorelbine has also been approved by the Danish Medicines Agency, but for a wide range of oncological therapies ... in 2003 when Alimta was tested [phase III] the bar had been set quite low. The study compared Alimta with a clearly inferior treatment that would not actually be offered to anybody. It would have been more relevant to study Alimta in combination with Cisplatin versus Vinorelbine with Cisplatin .... S has made a phase II trial of the standard therapy [Vinorelbine] ... Subsequently the standard therapy regimen has been expanded to include Alimta, which is not a better product than Vinorelbine, but eight times more expensive ... if two drugs are equally effective, but one of them is eight times more expensive than the other, patients will be offered therapy using the cheaper drug. ... The standard therapies now offered by Copenhagen University Hospital are Vinorelbine in combination with Cisplatin for inoperable patients and Alimta in combination with Cisplatin for operable patients ... the shift to Alimta as the standard therapy at Copenhagen University Hospital did not reflect that Alimta was medically better. The [applicants’] programme had had a large impact as patients were asking not to be treated with Vinorelbine. Copenhagen University Hospital had therefore had to change medical products because patients had the clear impression that Vinorelbine was not as good as Alimta ... It is quite usual for Copenhagen University Hospital to surrender material to the press and to answer questions, but the questions of [the first applicant] were never-ending. Copenhagen University Hospital has spent about a man-year, or about DKK 400,000, responding to inquiries from [the first applicant], and huge efforts had been made to accommodate her requests ... the programme had created distrust towards both Copenhagen University Hospital and S and had created uncertainty in both patients and relatives. He had received 50 to 100 “hate mails” himself ...”
18.  By a judgment of 9 April 2010, the Copenhagen City Court found against the applicants (and the Director of DR) and sentenced them each to 10 day-fines of 1,000 Danish Kroner (DKK). The allegations were declared null and void. The reasoning was as follows:
“...
Based on the evidence, the City Court accepts as a fact that in 2004, following a phase III trial, EMEA approved Alimta in combination with Cisplatin for treating patients suffering from inoperable malignant pleural mesothelioma and that subsequently the same was approved by the Danish Medicines Agency. The court also accept as a fact that Vinorelbine is a drug dating back more than 20 years whose effect had been documented by clinical experience and approved by the Danish Medicines Agency for a wide range of oncological therapies. Finally, the court also accepts as a fact that it has not been documented that Alimta therapy in combination with a platin medicinal product is more effective than Vinorelbine therapy in combination with a platin medicinal product.
As regards the term “experimental drug” the court accepts as a fact that a drug administered to patients in a trial is referred to as an experimental drug, no matter whether the same drug is the standard therapy offered outside the trial setting.
No matter that [the applicants] are deemed to have been aware of the above circumstances following their comprehensive research of the matter, it was said in the programme that, for dying patients, [S and Copenhagen University Hospital] had prescribed a “non-approved chemotherapy regimen” not approved for the diagnosis or which was not “the correct chemotherapy”, and that [S and Copenhagen University Hospital] used an “experimental drug”, the “worst-case scenario being that patients would die earlier than if they had been treated with an approved substance”, or that it would have “fatal consequences”. Moreover, the phrase “the only drug with a known effect” was used.
Since no account was given in the programme of the above-mentioned trials and approval process and the terminology applied for that process, the court finds that it would seem to a non-professional viewer that Alimta was the only effective drug for mesothelioma, particularly because the programme linked the treatment of two patients with Vinorelbine to their death, whereas the prospect of several more years to live was held out to the one patient who had been given Alimta therapy in Germany.
Moreover, the programme also linked S’s use of Vinorelbine to his personal esteem and his “personal research account”, although [the applicants] had been made aware of the research grant management procedure though Professor M’s memorandum of 23 September 2008 before the broadcast.
Since no account was given either of the procedure for managing research grants, the court also finds in this respect that it would seem to a non-professional viewer that S had a personal financial interest in starting Vinorelbine treatment rather than Alimta.
The [applicants] are therefore considered to have violated Article 267 of the Penal Code.
According to the information on [the applicants’] knowledge after their comprehensive research of the matter, the court finds no basis for exempting them from punishment or remitting the penalty under Article 269 of the Penal Code, compare also Article 10 of the Convention.
...
[The applicants] are furthermore jointly and severally liable for paying legal costs of DKK 62,250.”
19.  On appeal, on 10 June 2011 the judgment was upheld by the High Court of Eastern Denmark (Østre Landsret) with the following reasoning:
“In the introduction to the programme ‘When the doctor knows best’ a narrator states, among other things: ‘A Danish doctor is entering a medical congress to show his research results. For years he has gone his own way, he has treated dying patients with chemotherapy that is not approved.’
Later during the programme, it is stated at which hospitals one can receive treatment for pleural mesothelioma cancer, that these hospitals co-operate with Copenhagen University Hospital, and a reference is made to a named Consultant, S, head of the Scandinavian Centre for treatment of pleural mesothelioma cancer.
During the various interviews, a narrator states, inter alia:
- ‘The doctor does not give his patients the only approved medication. Instead, he uses a test medication. In the worst scenario, that may result in the patients dying earlier than if they had been given the approved substance.’
- ‘There is only one approved chemotherapy against pleural mesothelioma cancer, but that is not offered to SP [one of the patients followed in the programme]. The doctors chose to treat her with a substance that is not approved for the diagnosis, and whose effect on pleural mesothelioma cancer is not substantiated.’
- ‘However, that chemotherapy turned out to have huge consequences for her [SP].’
- ‘S can freely choose the medication that he thinks is best. There is only one treatment which, in comparative studies, has proved to have an effect on pleural mesothelioma cancer. Accordingly, that is the only medication which is approved as treatment. That medication is called Alimta. However, S chose not to use that medication on his patients.’
- ‘Thus, it has not been proved whether Vinorelbine works. According to the calculations made by DR, close to 300 patients in Denmark have been given test medication. In the worst scenario, that may result in patients dying earlier than if they had been given the approved medication.’
-’For her [SP] the lack of effect of treatment by Vinorelbine turns out to have had fatal consequences.’
- ‘The family K ask themselves why S goes his own way. They suspect that he has other interests than those of the patients. That suspicion grows, when they talk to SK’s personal doctor.’
- ‘It turns out, however, that S may also have had other reasons for choosing Vinorelbine. Because he has used this medication in medical tests on the patients. In a phase when they are fighting for their lives.’
-’The question remains: why does S carry out tests with Vinorelbine? Could it have something to do with the prestige which is implicit in having research articles published?’
- ‘We do not know whether it is prestige that impels S.’
- ‘Thus, S will not acknowledge what leading experts agree on; [namely] that Alimta is the only medication whose effect is substantiated.’
- ‘Here it turns out that S has received more than DKK 800,000 over the last five and a half years from the company F. That is the company behind the test medication Vinorelbine. The money has been paid into S’s personal research account. DKK 90,000 is earmarked for the tests. S withheld that information.’
The programme ends by informing us, among other things, that two of the patients who were interviewed have passed away. The narrator says, inter alia:
‘TJ, who was part of S’s tests with Vinorelbine, died on 4 January 2008.’
With these statements, [the applicants] not only passed on assertions by patients, relatives and experts, but also took a stand, so that the programme undisputedly gave the viewers the impression that malpractice has occurred at Copenhagen University Hospital, in that S has deliberately used medication (Vinorelbine), which is not approved for treatment of pleural mesothelioma cancer, and whose effect has not been substantiated, that the medication in question was part of a test, and that the test medication has resulted in patients dying or having their lives shortened. The way that the programme is built up with its beginning and ending, the viewers get the clear impression that the reasons behind this choice of medication [Vinorelbine] were S’s professional prestige and personal finances.
Against this background, in the programme, the applicants, as producer of the programme and as chief sub-editor, have made an allegation against Copenhagen University Hospital and S of malpractice and of nourishing irrelevant considerations to the detriment of the lives and health of patients. Such an accusation is likely to disparage [Copenhagen University Hospital and S] in the eyes of their fellow citizens as set out in Article 267 of the Penal Code. It must have been clear to them [the applicants] that they were making such an allegation by way of their presentation of the programme.
The applicants have not attempted to establish the truth of the allegation, but have submitted that the allegation shall be unpunishable by virtue of Article 269 (1) of the Penal Code as they acted in lawful protection of an obvious public interest or the interest of others or, in the alternative, that punishment should be remitted under Article 269 (2) of the Penal Code because they were justified in regarding the allegations as true.
These provisions must, in connection with Article 267 of the Penal Code, be understood in the light of Article 10 of the Convention on the protection of freedom of expression. A very considerable public interest is related to journalistic discussion about risk to life and health, or suspicion thereof, as regards public hospital treatment. When balancing considerations of freedom of expression with considerations of the protection of the name and reputation of persons and companies, the former is accorded tremendous weight on the scale. That entails acknowledgement of a very far-reaching freedom of expression for the press, and accordingly the press must be permitted, as the public control- and information organ (‘public watchdog’), a certain amount of exaggeration and provocation in connection with their discussion of these questions, when factually there are reasons for expressing criticism.
On the basis of the information in the case, including the research material that the applicants possessed before the broadcast of the programme, in particular the emails from [the medical doctor from Grosshandorf Hospital in Germany and the professor from Switzerland], the replies by the Minister for Internal Affairs and Health to various questions [posed by Members of Parliament], and the memorandum of 11 June 2008 produced by Copenhagen University Hospital [about pleural mesothelioma cancer], it can be established that Vinorelbine in combination with Cisplatin or Carboplatin was standard treatment at Copenhagen University Hospital, that the European Union on 20 September 2004 approved the marketing of Alimta in connection with Cisplatin for treatment of inoperable patients with pleural mesothelioma cancer, that there was no substantiation or basis for believing that an Alimta-based treatment was more efficient than the treatment offered by Copenhagen University Hospital, that some patients at Copenhagen University Hospital, who were already about to receive Vinorelbine as standard treatment, were chosen and offered the same medicine as part of a test [it is not known for what], and that S did not make any private financial profit from these tests.
Against this background, including the fact that the word ‘approved’ was not explained during the programme, namely the difference between medication approved for treatment and [medication] approved for marketing, and by consistently using the word “test medication”, even though only one patient in the programme participated in tests, [the applicants] made allegations which were based on an incorrect factual basis, of which they must have been aware via the research material.
The aim of the programme – to make a critical assessment of the treatment of patients with pleural mesothelioma cancer offered by Copenhagen University Hospital and the responsible consultant – is a legitimate part of the press’s role as ‘public watchdog’, but it cannot justify an allegation, which is built on a factually incorrect basis, and thus a wrong premise. [The applicants], who did not limit themselves to referring to or disseminating statements by experts, patients and relatives, did not have any basis for making such serious allegations against Copenhagen University Hospital and S. The allegations cannot be justified on the grounds that Copenhagen University Hospital and S refused to participate in the programme.
Against this background, and since in relation to Article 10 there is no interest to protect when there is no factual basis for the accusations, the allegations are not unpunishable under Article 269 (1), nor is there any basis for remitting the punishment under Article 269 (2) [of the Penal Code].
It is an aggravating factor that the wrongful accusations were disseminated on national television during primetime and on DR’s homepage, by means of which the accusations had a significant spread.
Accordingly, [the High Court] agrees [with the Copenhagen City Court’s judgment] that [the applicants] be fined under Article 267, and that the allegations be declared null and void by virtue of Article 273 (1).
The High Court thus dismisses the appeal and upholds the judgment of the Copenhagen City Court.
The applicants shall be jointly and severally liable for paying legal costs of the High Court appeal to Copenhagen University Hospital and S, in the amount of DKK 90,000, which constitutes the legal fee inclusive of VAT. In fixing the amount, the High Court took into account the scope and duration of the case.”
20.  On 27 October 2011 the Appeals Permission Board (Procesbevillingsnævnet) refused the applicants’ request for leave to appeal to the Supreme Court (Højesteret).
21.  Subsequent to the broadcast on 24 September 2008 of the television programme, four complaints were lodged with the Patient Insurance Association (Patientforsikringen) relating to the issues raised by the programme. A press release published on the Associations’ website on 9 March read as follows:
“As of today, the Patient Insurance Association has received four complaints relating to the treatment of mesothelioma patients with combinatorial drugs other than Carboplatin and Alimta. That treatment was questioned by the Danish Broadcasting Corporation (DR) in a documentary programme in September 2008.
The Patient Insurance Association has received four complaints relating to the criticism raised. This means that the persons claiming compensation are either patients or their dependants, one of the reasons being their belief that the combinatorial drugs administered to treat the disease were incorrect ones.
All four complaints have been refused, one of the reasons being that the independent medical oncologists who assessed the cases found that it was in compliance with optimum medical standards to treat patients with the selected combination therapy.
Two of the cases have been appealed against to the National Agency for Patients’ Rights and Complaints (Patientskadeankenævnet). The National Agency for Patients’ Rights and Complaints upheld the decision of the Patient Insurance Association, finding, inter alia:’... [patients] were offered Carboplatin and Vinorelbine, which must be considered to be as active as other combinations with a favourable profile of adverse reactions’. The other appeal does not concern the issue of combination therapy.”