If scientists quarrel whether a vaccine caused a disease, it's left to the courts - CJEU in W and Others (C-621/15)

On June 21 the CJEU decided in the case of product liability related to a potentially defective vaccine - W and Others (C-621/15). Mr W was vaccinated against hepatitis B in the years 1998-1999 with a vaccine produced by Sanofi Pasteur. He was diagnosed with MS in November 2000, which first led to his disability from work, then needing round-the-clock care, and finally his death in October 2011. Together with his three family members he raised a claim against Sanofi Pasteur in 2006, arguing that his illness resulted from the administration of the vaccination.

Vaccinations have long been a controversial topic as the available medical research has not been able to either conclusively prove their detrimental effects to human health or to conclusively disprove them. This is at least confirmed in this case with respect to the lack of medical research establishing a relationship or lack thereof between the hepatitis B vaccination and the multiple sclerosis disease (par. 30). Article 4 of the Product Liability Directive requires the consumer to be able to prove not only the damage, and its cause but also the causal link between the two. What evidence was submitted in this case? Mr W and Others claimed that the short period between the vaccination and the appearance of first symptoms of MS should be considered, as well as the fact that there was no trace of family history of this disease. These facts "are such as to give rise to serious, specific and consistent presumptions as to the existence of a defect in the vaccine and as to there being a causal link between the injection of the vaccine and the occurrence of the multiple sclerosis." (par. 11) 

In French law, which was applicable to this case, the Cour de cassation stated previously that with regard to the defective vaccines and the liability of pharmaceutical companies for their production, the causal link could be derived from "serious, specific and consistent presumptions". So even if the medical research does not confirm a relationship between the vaccination and the occurrence of the disease, the court could establish the defect in the vaccine and the causal link between it and the damage based on, indeed, the lack of medical family history with this disease and the short time that passed between the vaccination and the occurrence of the disease (par. 13). I think it bears repeating: despite the lack of medical research evidencing this relationship.

Considering that the PLD does not specify what should be considered a sufficient proof of the causal link between the defect and the damage that the consumer needs to establish, it is left to the Member States to decide what evidence is admissible, the level of proof required and the rules for national courts how to evaluate it (par. 25). The established procedural rules should comply with the principle of effectiveness, of course (par. 26), which cannot lead, e.g., to the shift in the burden of proof pursuant to Article 4 PLD or undermine the effectiveness of the strict liability system adopted by this Directive (par. 27). The CJEU confirms that the French procedural rules do not lead to such a shift in the burden of proof but rather just alleviate it by making it easier for consumers to establish the causal link - without having to "produce, in all circumstances, certain and irrefutable evidence of a defect in the product and of a causal link between the defect and the damage suffered" (par. 28). The national court may then conclude that "such a defect has been proven to exist, on the basis of a set of evidence the seriousness, specificity and consistency of which allows it to consider, with a sufficiently high degree of probability, that such a conclusion corresponds to the reality of the situation." (par. 28). Furthermore, the possibility to ban the use of circumstantial methods in proving the causal link would be contrary to the PLD, esp. in situations like here: where the medical research is inconclusive (par. 30), as it would disallow consumers' successful claims of product liability due to excessively difficult burden of proof (par. 31). 

Generally then, the CJEU accepts a possibility that national law establishes producers' liability only on the basis of circumstantial evidence. However, it continues to observe that procedural rules may not harm producers by accepting "unjustified presumptions" (par. 34). When would this occur? For example, if national courts are overly rigorous in their application of these evidentiary rules and start accepting irrelevant or insufficient evidence, as a consequence (par. 35). The CJEU goes even further, if national court would draw an automatic presumption on the existence of the defect and of causal link, just because "one or more types of factual evidence were presented together" - this would lead to the disregard of the burden of proof as "the producer could then find itself, even before the courts ruling on the merits of the case had the opportunity to familiarise themselves with the producer’s evidence and arguments, in the position of having to rebut that presumption in order to defend itself successfully against the claim" (par. 36). Therefore, the producer's right to defense needs to be respected.

Concluding, the national court may use circumstantial evidence - if it is sufficiently serious, specific and consistent - to conclude that despite the producer's arguments and evidence presented by him "a defect in the product appears to be the most plausible explanation for the occurrence of the damage, with the result that the defect and the causal link may reasonably be considered to be established." (par. 37).

The CJEU actually addresses the facts of this particular case in the par. 41-42 of the judgment. It seems to advise the national court that in the given case it could be likely to establish a defect and causal link, considering the lack of medical family history of the disease, temporal proximity between the vaccination and the occurrence of the disease, but also the existence of a significant number of reported cases of the disease following such vaccines being administered. This could make it the most plausible explanation for the national court that the administration of the vaccine led to the disease and that the vaccine, therefore, did not offer the safety it should have. But such conclusions have to be drawn "in a fully enlightened manner in each specific case" - the producer's rebuttal being the most important evidence to the contrary.

I think this judgment may lead to quite some disputes. On the one hand, supporters of medical research may feel that the lack of conclusive evidence of the harmful effects of the vaccination should not lead to producers' liability. On the other hand, considering the difficulties consumers would have in acquiring conclusive proof based on medical research, that's contrary, of the harmful effects of the vaccine, the alleviation of the burden of proof might seem reasonable to others.

Less antibiotics, more milk and fruits

The Health Committee voted yesterday on a resolution that aims at improving EU healthcare. Among other measures, the MEPs hope to encourage doctors to be more restrictive and responsible in prescribing antibiotics (also to animals) as well as to prohibit their sale without prescription; to motivate pharma companies to search for new antimicrobial agents (with resistance reaching 25% for commonly used antibiotics in several MS); to monitor more strictly potential conflict of interests between producers and prescribers of drugs. This resolution is the result of a report showing that 8-12% of patients admitted to EU hospitals experience adverse effects while receiving healthcare (e.g. infections) while ca 50% of these occurrences could have been avoided. (Health MEPs propose blueprint for safer healthcare)

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Also yesterday, the Agriculture Committee amended draft rules on schemes to provide fruit, vegetables and milk in schools encouraging MS to better and at a larger scale promote healthy eating and consumption of local food amongst children. Two, so far separate, schemes will be merged - on providing milk and fruit to schoolchildren (which should reduce the administrative burden for upholding them). The Committee introduces a proposal to enable EU funding for local milk products such as yoghurt, cheese and curd (as long as they do not contain added flavouring, fruits, nuts or cocoa); to require MS to spend 10-20% of the EU funding on additional educational and promotional activities related to healthy eating habits (visits to local farms, distribution of local specialties etc.); to increase the EU funding in this area and to better divide it amongst the MS. (Milk and fruit in schools: agriculture MEPs promote healthy eating)

Advertising medicinal products

On 3 March 2015 Advocate General Szpunar delivered his opinion in joined cases C-544/13 and C-545/13 Abcur.

The Swedish case, which led to the preliminary questions assessed by Szpunar, deals with a dispute between Apoteket, a State-owned company which produces and markets two products without having obtained an authorisation for sale as a medicinal product pursuaent to Regulation (EC) No 726/2004 and Abcur, a pharmaceutical company which manufactures and markets two similar products and which has obtained an authorisation pursuant to Regulation (EC) No 726/2004. Abcur’s complaint against Apoteket concerns the fact that Apoteket manufactures the products without an authorisation and some measures employed by Apoteket to present the products. Among 7 complex questions referred to the Court, these of special interest for consumer law covers the question, whether Directive 2005/29/EC on unfair commercial practices advertising are also applicable for medicinal products for human use falling under Directive 2001/83/EC and whether Directive 2006/114/EC on misleading and comparative can apply to advertising falling outside the scope of Directive 2001/83.

According to Szupnar, Directive 2005/29 and Directive 2001/83 can apply, in principle, in parallel (para 58). Szpunar points out that the directive is without prejudice to Union or national rules relating to health and safety aspects of products (Article 3(3) of Directive 2005/29) and that Article 3(4) of the directive states that in the case of conflict between its provisions and other Community rules regulating specific aspects of unfair commercial practices, the latter shall prevail and apply to those specific aspects. Moreover, a combined reading of Article 7(5) of and Annex II to Directive 2005/29 demonstrates the complementary character of Directive 2005/29 and Directive 2001/83 – information required by EU law in relation to commercial communication including advertising or marketing is to be regarded as material information for the purposes of defining a misleading omission (paras 58–61).

The referring court does not relate to the substantive requirements of Directive 2005/29. Nevertheless, Szpunar underlines that the scope of the directive is limited to business-to-consumer commercial practices and it addresses commercial practices directly related to influencing consumers’ transactional decisions in relation to products. Consequently, only information accessible to consumers can be regarded as falling within the scope of the directive whereas the medicinal product in question can only be acquired through a prescription by a doctor (par. 65–68). In that case, the consumer is adequately protected by the doctor. However, Directive 2005/29 can be applied if a court finds that there is “a connection between the information provided and influence on the doctor to prescribe the product at the instigation of the consumer/patient” (para 69).

As regards Directive 2006/114 Szpunar recalled that the directive’s scope is confined with respect to misleading advertising to business-to-business relations. The directive applies to any particular sector of economic activity, unless there are specialised rules governing such a sector. In the absence of an explicit exclusion of Directive 2006/114, it should be applicable. Therefore, Directive 2006/114 is applicable also to medicinal products which fall outside the scope of Directive 2001/83 (paras 80–83).

Finally, Szpunar clarifies the term ‘advertising’ defined in Article 2(a) of Directive 2006/114 as making of a representation in any form in connection with a trade, business, craft or profession in order to promote the supply of goods or services. It has been confirmed by the Court that this is a particularly broad definition which covers various forms of advertising. However, Article 86(2) of Directive 2001/83 excludes from the application of Title VIII on Advertising a range of measures like labelling and accompanying package leaflets and factual, informative announcements, and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided that they include no product claims. These measures cannot constitute ‘advertising’ for the purpose of Article 2(a) of Directive 2006/114, because the general rule on advertising to which economic operators are subject should not be stricter than a special rule. Though, it has to be borne in mind that the crucial element is whether it can be objectively determined that the representation has been made with a view to promoting the supply of a good or service. The Court held in MSD Sharp & Dohme that Article 86(1) of Directive 2001/83 did not, in principle, preclude the possibility that published or distributed material which includes only objective information could be regarded as advertising and that ‘[i]f the message is designed to promote the prescription, supply, sale or consumption of medicinal products, it is advertising for the purposes of that directive. However, material which is purely informative, without promotional intent, is not covered by the provisions of that directive relating to advertising of medicinal products.’ (paras 86–90 and MSD Sharp & Dohme, para 35). It is therefore for the referring court to establish these factual matters so as to determine whether and to what extent the activities at issue in the main proceedings constitute advertising within the meaning of Directive 2006/114 (para 92).

To be confirmed by the Court of Justice of the European Union…

Producers of medicines must share information on their adverse effects - CJEU in Novo Nordisk Pharma (C-310/13)

20 November 2014: CJEU judgment in Novo Nordisk Pharma GmbH (C-310/13)

We wrote before on this blog about the problem presented in the case Novo Nordisk Pharma (Consumer's right to information about medicine's side effects - AG Szpunar in Novo Nordisk Pharma (C-310/13)). Yesterday, the CJEU gave its judgment, deciding that the Product Liability Directive and its maximum harmonisation character do not preclude such national legislation that imposes on trader's information duties not mentioned in this Directive. (Par. 33)

As a brief reminder, Article 13 of the Directive allows Member States to uphold such national special systems of liability that existed in a given Member State at the moment of notification of this Directive to the Member State. Germany has a special system of liability applicable to cases when consumers' health is damaged due to the use of medicines. This special liability system was, however, amended after the Directive has been notified by introducing a consumer's right to request from the producer of the medicinal product information on the adverse effects of that product. The German courts were unsure whether this requirement was, therefore, compliant with the Directive.

The CJEU confirms one of the views expressed by AG Szpunar, namely, that since the Directive does not regulate information duties of the producers, the consumer's right to request such information falls outside its scope (Par. 25, 29). Recital 18 of the Directive confirms that it doesn't aim to exhaustively harmonise the sphere of liability for defective products beyond the matters regulated by it (Par. 24). While the Directive places the burden of proof that the product was defective and caused damage on the consumer, the national legislation allowing consumers to request information on side effects of the medicinal products does not reverse that burden of proof but rather may only alleviate it (Par. 26-29). The CJEU does not see a possibility for the German provision to distort the effectiveness of the Directive's system of liability either (Par. 30-31).

All in all, this is good news for German consumers who may continue to require producers of medicinal products to send them detailed information on adverse effects of their medicines, which may enable consumers' claims for damages.

Synthetic weed not a 'medicinal product' - CJEU in D (C-358/13)

10 July 2014: CJEU judgment in case D (C-358/13)

Mr. D. sold in his shop ("G.- All about hemp") small bags of herbs with added synthetic cannabinoids as air fresheners, not meant for human consumption. There was no information on the bags as to either fixed quantities of any active substances or dosage guidance. Mr D. was, however, supposedly aware that his customers used these bags as a substitute for marijuana and was sentenced to prison due to introducing 'unsafe medicinal products' on the market. Synthetic cannabinoids has been classified as an unsafe medicinal product in German law, where its potential negative side effects were taken into account. The question referred to the CJEU is whether this product could be considered to be a 'medicinal product' as defined by the Directive 2001/83 on the Community code relating to medicinal products for human use, which the German law was implementing. What is the issue here?

The definition of a medicinal product in Article 1(2) of the Directive requires it to treat or prevent diseases in human beings or to have a beneficial effect on their physiological functions (according to the settled case law - Par. 33-38). The synthetic marijuana has not been proven to bring any benefit to human health but is only confirmed to modify physiological functions in humans (not necessarily for the better), and is being used to induce a state of intoxication, which as such is considered harmful to human health (in an objective manner). (Par. 26) If the definition of a medicinal product is limited only to such products that are supposed to contribute to consumer's immediate or long-term well-being the synthetic cannabinoids may not, therefore, be classified as such. The CJEU concludes that such products as mentioned in this case may not be seen as a medicinal product and are, consequently, not subject to the rules governing the introduction of medicinal products to the market. Even if it means that selling such products may, therefore, not bring about any criminal sanctions, this does not undermine this conclusion, pursuant to the CJEU. (Par. 48)

Consumer's right to information about medicine's side effects - AG Szpunar in Novo Nordisk Pharma (C-310/13)

11 June 2014: AG Szpunar in case Novo Nordisk Pharma (C-310/13)

Today, AG Szpunar issued an opinion regarding interpretation of Article 13 of the Product Liability Directive (No 85/374). Article 13 determines the scope of the Directive's application, where it should not affect any rights that an injured person may have pursuant to a national special liability system existing at the moment of this Directive's notification to the Member States.

In the given case, Ms. S, domiciled in Germany, claimed that she was injured through the use of a medicinal product (Levemir) introduced on the market by Novo Nordisk Pharma. German law excludes the application of the Directive in cases of damage to consumer's health resulting from a use of medicines, since to these cases a special system of liability applies, as established by the Arzneimittelgesetz ("AMG") prior to the implementation of the Directive in German law (Par. 84 and Par. 84a AMG). To claim compensation under this liability system the consumer may demand from the pharma company information on the known to the pharma company side effects of that medicine, potential interactions, and all other test results as well as data about consequences of using this medicine on human health, as long as this data may influence the assessment of whether the health damage resulted from the use of the medicine in the given case. Novo Nordisk Pharma refused to comply with its obligation to provide this information and appealed the need to do so. BGH asks the CJEU whether the German system of liability applicable to damage to consumer's health resulting from the use of medicines falls outside the scope of the Directive and, therefore, may be regulated independently from its provisions. Clearly, without her right to this information Mrs. S would be unlikely to prove that she suffered any damage due to her use of the medicine, since it would be hard for her to find sufficient scientific evidence. Therefore, if the CJEU would exclude the application of the AMG's provisions to this case, consumers could be devoid of necessary protection against faulty medicines.

AG Szpunar looks at the text of Article 13 and concludes that it means to allow consumers to use an alternative compensation scheme that predated the Directive. (Par. 28) However, pursuant to AG Szpunar literal interpretation of this provision points out that with regards to the special liability systems (like AMG), the Directive limits the possibility to use them only to circumstances when the rights of consumers under such special liability systems existed at the time of the Directive's implementation. It is not, therefore, the special liability system that needed to be in force prior to the Directive's implementation but consumer's entitlement to claim certain rights under this system. (Par. 30-32) Due to such interpretation, it will not be possible for one Member State (Germany) with regards to one production sector (medicine products) to differentiate and further develop a liability system. (Par. 37) This would mean that since Mrs S rights under the AMG system arose after the Directive's implementation, she could not claim her damages using AMG's provisions.

At the same time, however, AG Szpunar remarks that the duty to inform by a pharma company as established in Par. 84a AMG has not been subject to any direct regulation in the Directive. (Par. 45) If a consumer is given a right to information it will enable her to easier prove the defect in a medicine that could have contributed to the health damage. The burden of proof is regulated by Article 4 of the Directive. This Article specifies what the consumer needs to prove to claim damages in product liability cases but it does not determine the methods thereof. The consumer's right to information as established in Par. 84a AMG does not reverse the burden of proof but is only meant to alleviate it, by balancing the information asymmetry between consumers and pharma companies. (Par. 46) As unregulated by the Directive, this matter may, therefore, be left to the national law's discretion. (Par. 47) Consequently, even if Mrs S would now be forced to claim her damages under the Product Liability Directive's scheme, she should still be able to benefit from the right of information as established in Par. 84a AMG to help her prove her damage.

European Parliament's last stands

Last week, the European Parliament voted in its plenary session on a few proposals that are important for consumers and their fate needs to be set prior to the end of term of the current Parliament. Let us take a short look at the results of last week's session:

Roaming fees and open access internet

In the first reading on the new Telecoms package, the European Parliament consolidated work conducted so far and is ready to give a further go at it to the new Parliament after the elections (see previously: MEPs say NO to roaming and YES to open internet). The package not only aims at abolishing roaming charges in Europe as of December 2015, but also at prohibiting internet access providers from blocking or slowing down selected services ensuring more net neutrality. (Ensure open access for internet service suppliers and ban roaming fees, say MEPs)

Clinical trials

We have previously mentioned on this blog the need for ascertaining more transparency of clinical trials' data, so that it could be more thoroughly tested and so that its' results could be subjected to more academic, objective scrutiny (see e.g. Who's keeping the score?...). This would increase patients' safety. On 2nd of April the European Parliament voted for a new proposal amending the existing Clinical Trials Directive. Pharma companies and academic researchers will now have to post the results of all their European clinical trials in a publicly-accessible database. The new law is also supposed to facilitate easier cross-border cooperation, which is expected to enable bigger, more reliable trials. The European Commission will be authorized to do the checks of reporting procedures, which themselves are simplified. (Clinical trials: clearer rules, better protection for patients) The proposal has already informally been agreed with by the Council so it should not take long to adopt it as law. This new proposal is welcomed by the European Ombudsman who often had to deal with complaints that citizens were refused access to clinical trials data (Clinical trials vote is a triumph for transparency in EU healthcare).

Medical devices

The MEPs voted in the first reading on the proposal for a new Regulation on medical devices in order to consolidate the existing various projects of that law and pass it on to the new Parliament. (see our previous post: New European rules on medical devices) We discussed the need for this law previously, mentioning the scandals with faulty breast implants, for example. New provisions are to enforce stricter monitoring and certification procedures of medical devices, therefore, increasing consumer safety. (Medical devices: better controls and traceability to ensure patients' safety)

Consumer payments

The European Parliament adopted also last week the proposal to cap bank fees for processing consumers' payments in the EU (at 0.3% of the transaction value for credit card transactions and at a maximum of seven euro for debit cards). (MEPs push for card payment fee caps and online payment safeguards) The caps will apply to both domestic and cross-border transactions and in time should lead to lower prices for card users. They will enter into force one year upon this law's adoption. Moreover, the MEPs decided to strengthen online payment safeguards by, among others, introducing a uniform set of information that would clearly state all charges, execution times, contact information and exchange rates. Unauthorized payment will need to be refunded within 24 hours of their being noticed. Consumers should not bear losses of illegal use of their stolen or lost cards above €50. (see our previous post: Money, money, money...)

Heigh-Ho Heigh-Ho, It´s Off To Work We Go!

Best wishes for 2014! That being said it is time to leave behind the holidays' spirit and to update our dear readers on what is going on currently in Brussels. Not much, that's the good news for anyone who took a bit of a break - you didn't miss much. However, just before Christmas on the 20th of December the European Council agreed its position on two relevant for consumer protection draft laws.

 

The first one, concerns a draft directive that is to improve the transparency and comparability of information on fees related to payment accounts. (see our previous post Money, money, money...) Upon the Council establishing its position it will now be time to negotiate this directive's provisions with the Parliament. (Council sets out its position on payment accounts)

 

The second measure is a draft regulation to facilitate and speed up the authorisation procedure of clinical trials. The goal of the EU is to encourage more clinical trials (the number thereof decreased by 25% between 2007 and 2011) while at the same time not giving up the necessary standard of patients safety. The timeline for authorisation of clinical trials is to be set at 60 days, with a tacit agreement having been given if no decision is taken within this time (! - I wonder how this is going to play out if/when the administrative bodies will be overloadedCouncil confirms agreement on clinical trials)

). When a clinical trial requires a substantial modification the decision about it will need to be taken in 49 days (again with tacit agreement rule). One single application will suffice to conduct clinical trials in different Member States. The next step in the adoption of these rules lies with the European Parliament. (

Not quite painless results of delaying entry of a generic painkiller to Dutch market

As we mentioned in February, the European Commission was examining the practices of pharmaceutics companies with regards to their delay in introducing cheaper, generic versions of a painkiller 'fentanyl' on the Dutch market (Consumer health update). Since the Commission could establish from the internal documents of the pharma companies that they agreed to delay the introduction of the generic meds for 'a part of [the] cake', the Commission had no doubts that the so-called 'co-promotion agreement' was really an anticompetition agreement and infringed the EU law. The US company Johnson & Johnson was fined with almost 11 million USD, while the Swiss company Novartis has to pay almost 5,5 million Euro in fines (Commission fines Johnson & Johnson and Novartis Euro 16 million for delaying market entry of generic pain-killer fentanyl).

Healthcare tourism

On October 25th the new Directive on cross-border healthcare of 2011 had to be implemented in all Member States. This means that currently consumers should be able to at their convenience go abroad in search of medical treatments and medical care. The new rules will make reimbursement claims less formalistic, provide better information to consumers on their patients rights and complaint procedures abroad. Additionally, consumers should be able to easier determine whether a given healthcare specialist is fit for practice and if they are issued prescriptions in another Member State they should be honored by the pharmacists in their country of residence, too. For more information, see Q&A of the European Commission.

The rules mentioned above harmonize situation of consumers who want to seek medical care abroad and of those who receive prescriptions from another Member State. However, it cannot be said that these rules guarantee patients' safety in Europe. If there are no strict, harmonized rules on authorization of medical devices, consumers could be severely harmed in the process. Imagine buying a pregnancy test during your holidays in another Member State, it being faulty due to more relaxed supervision measures and you ending up believing you are not pregnant and partying weeks long to your health's detriment. To prevent such black scenarios on 22 October the European Parliament looked into another subject related to improving healthcare in Europe - the safety of medical devices. The review of currently binding rules is to bring about more disclosure towards consumers on medical devices and involve them in the monitoring of such devices. A great idea is the facilitation of reporting defects. BEUC still argues for more changes in the newly drafted law, however, asking the European institutions to put a stop to producers using consumers as guinea pigs of their products and instead putting stricter rules on when products may enter the European market. (Parliament opens the door to safer medical devices)

More support of public access to clinical trials data

A short update to our posts (last one: Who's keeping the score?...) on the dispute between the European Medicines Agency (EMA) and two major pharmaceutical companies (AbbVie and InterMune) regarding transparency and sharing of clinical trials data: the European Consumer Organisation (BEUC) has been accepted to intervene on the EMA's side in the procedures in front of the Court of Justice. (Consumers to support public access to clinical trials data in Court)

On publication bias in medicine research

Great TED talk by Ben Goldacre on publication bias in medicine research which might influence which medicines are being prescribed to consumers, as well as could be another argument in favour of sharing clinical research data. (see further Who's keeping the score?)

Who's keeping the score? Consumer health & drugs safety vs. money, money, money for pharma industry

In May this year we mentioned that there is a battle raging in Europe over the access to clinical trials' information. While the worldwide trend seems to be increased disclosure in order to improve transparency of clinical trials and to contribute to consumer health, an opposite tendency is shown in Europe. Major pharma companies try to keep the data of their clinical trials as secret as possible, for as long as possible, claiming protection under 'commercially confidential information' laws, privacy of patients data laws, etc. (Interim injunctions to stop EMA from releasing non-clinical and clinical data) (Trying for better clinical trials)

The Guardian reported last week that pharma companies are now trying to involve their patients to support their claims on keeping clinical trials data confidential, in a battle against EMA's work to make more of these data public. (Big pharma mobilising patients in battle over drugs trials data) As we mentioned before, the whole idea about making clinical trials data public (or more public) is to allow independent scientists to replicate the results of the trials and to test health claims that are being made during them. This should increase the medicines' safety. However, as Guardian reports, currently only about half of all clinical trials are published in full, and positive results of such trials are twice as likely to be published than negative ones.

A memo that was leaked to the press by a drugs company employee shows how two large pharma trade groups (PhRMA - Pharmaceutical Research and Manufacturers of America and EFPIA - European Federation of Pharmaceutical Industries and Associations) strategized in order to influence public opinion on this subject. Under the pressure from the industry, various patients groups (who are often sponsored by the industry) were to start expressing their fears that in case clinical trials data is released it may be misinterpreted and endanger public health by scaring people to use certain drugs. Apparently, European Parliament has already witnessed such a lobbying from patients groups against the proposal on the clinical trials directive.

This leak was just what was needed, it seems, to further mobilise opposition against pharma industry. Despite attempts to rectify the situation after the leak was publicised - EU and US pharma companies pledging to share clinical trial data responsibly - the damage to their credibility has been done. As a result BEUC announced on 24 July this year that it will support EMA in its pending cases in front of the CJEU against pharma companies (read earlier posts on this).

Monique Goyens, Direction General of BEUC, said: 

"The pharma industry raised concerns about the risk of trial information being misinterpreted and causing health scares. But currently, the only existing evidence points to the health risks of secrecy and non-disclosure. Several drug-related scandals could have been prevented and many lives saved

had trial data been examined by independent researchers."

Trying for better clinical trials

Yesterday, the Public Health Committee endorsed new draft EU rules on clinical trials of new medicines. Since the past years showed a decline in the number of conducted clinical trials in the EU, there is a clear need to change the rules that could have been responsible for this (e.g. the existing Directive 2001/20 is said to unnecessarily increase bureaucracy, overlook the option of non-commercial clinical trials). The new rules are to increase the transparency by making it mandatory to publish detailed summaries in publicly accessible EU database, with full Clinical Study Reports published once a decision on authorisation is complete. There would be a new rule on compensating damages, pursuant to which low-risk clinical trials could be covered by the general compensation system of a health care system. Additional provisions would regulate the ethics of conducting clinical trials on certain patients. (Clinical trials: clearer rules, better protection)

Inverted black triangle

Tonio Borg, European Commissioner for Health and Consumer Policy, announced that as of September 2013 on the inside leaflet of certain medicinal products an inverted, black triangle will appear. This will be the result of the adoption of the regulation implementing further EU pharmacovigilance legislation (pharmacovigiliance system allows for the monitoring of the medicine's safety throughout its lifespan). If consumers see such a symbol:

they should realize that this particular medication is subject to additional monitoring. The text of the leaflet will encourage consumers to report unexpected adverse reactions and direct them to the national reporting system. (Q&A)

Generic medicines

The European Parliament voted last week on a draft new law relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance system (see here for the resolution). The new law intends to introduce fair practices across the EU applying to purchasing 'generic' medicines (which should be available two years after the original branded medicine), making sure that their prices are transparently set (which should lower them) and that reimbursement through insurance systems would be easy and quick to claim. For example, a 60-day time limit to decide on the pricing and reimbursement is to be introduced. Such a time-limit would prohibit companies marketing the originally branded medicines to delay the introduction on the market of the generic medicines.

Consumer health update

The French medicines agency (ANSM) announced this week that in the next three months it intends to suspend the marketing authorisation for Diane 35 and its generics for acne treatment in France. This is a commonly used medicine across Europe, used not only to treat acne but also as an oral contraception for women and for treatment of other skin conditions. The ANSM considers the risk of thromboembolism that this medicine increases (which has been known for many years now) to be too high in comparison with its moderate success in treating acne. Pursuant to EU law, the ANSM will notify the European Medicines Agency about its plans and appealed for a EU-wide review of this medicine, which may lead to a harmonized action with respect to its marketing across the EU Member States. In the meantime, women who are taking this medicine are advised NOT to stop. (EMA update on Diane 35 and generics used in the treatment of acne) Of course, that does not mean that if anyone feels uncomfortable with it (though, as I have mentioned, the risks were known for quite awhile now), they may ask their doctors if there are any alternative treatments available.

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EU Commission in the meantime calls for EU-wide ban on amphetamine-like drug '4-MA', which is a synthetic substance inducing similar physical effects to amphetamines.The Commission appeals to MS to prevent free access across the EU to this drug, since it has been associated with 21 deaths in 4 EU Member States in 2010-2012. So far, it has been made illegal in 10 EU countries. The EU action aims at prohibiting both manufacturing and marketing of this drug, subject to criminal sanctions. (Commission calls for EU-wide ban on amphetamine-like drug '4-MA')

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World Health Organisation (WHO) released today a new report on long-term exposure to air pollution which apparently can trigger: atherosclerosis, adverse birth outcomes, childhood respiratory diseases. It may also adversely influence neurodevelopment, cognitive function, diabetes, cardiovascular and respiratory systems. (Newly found health effects of air pollution call for stronger EU air policies) Current EU statistics show that over 80% of EU citizens are exposed to air pollution levels above the 2005 WHO Air Quality Guidelines (AQGs), which has been seen as depriving on average each citizen of 8,6 months of life. The new report recommends that EU modifies its law, since already the current limit of permitted air pollution in the EU's Ambient Air Quality Directive is twice as high as the AQG recommendation. The WHO plans on adjusting the AQGs levels, making them even more strict. We'll see what actions will be undertaken by the European Commission. For now, 2013 has been declared as the Year of Air for EU policies. (apparently it's not the first year of air... - see: here)

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The European Commission also sent this week a statement of objections to the pharmaceutical companies Johnson & Johnson (specifically, its Dutch subsidiary: Janssen-Cilag) and Novartis (and its subsidiary Sandoz). It suspects that these companies concluded a so called 'co-promotion agreement' on a strong pain-killer (fentanyl, which is stronger than morphine), as a result of which the market entry of a cheaper generic medicine was delayed in the Netherlands. This, of course, would breach EU antitrust rules. Dutch consumers, as a result of this agreement, could have been left with no option but to purchase the higher priced fentanyl which goes against the EU policy to provide affordable healthcare to EU citizens. The companies may now respond to the objections raised by the Commission. If the infringement of antitrust rules is confirmed, they will be fined. (see more here) To find out more about other enforcement actions in pharmaceutical sector following recent sector inquiry, see here.

Travelling for the sick

Travelling while sick is never pleasant, nor is it easy to take some medicines with you - taking into account, for example, airport restrictions. Yesterday, the European Commission adopted also pan-EU rules defining the minimum list of elements that need to be included in a medical prescription taken by a patient travelling from one Member State to another. These new EU provisions would enable cross-border identification of the patient, the prescriber and the prescribed product, diminishing delays, interruptions in treatment and extra costs. The plan is for the Member States to implement these rules by 25 October 2013. Currently, it is believed that over half of patients would have problems with their prescription being recognised in another Member State and only ca 2,3 million cross-border prescriptions are issued. I'm curious, however, how these new rules would work in practice since they do not prescribe the same appearance, format or language for the prescriptions. See more here.

Back to the pre-antibiotic era?

The European Parliament adopted a resolution today in which it warns against neglecting antimicrobial resistance. Currently, bacteria that are resistant to antimicrobial drugs cause 25,000 deaths a year in the EU, Iceland and Norway. This significant amount suggests that more money should be spent on developing new, better drugs, as well as careful usage of existing drugs and improvements of animal husbandry should be reinforced. (Parliament calls for immediate action to tackle antimicrobial resistance)

I find this news interesting, coming from Poland where you are prescribed antibiotics for anything - it's enough you sneezed a few times, but living in the Netherlands - where you won't get an appointment with a doctor if you haven't been sick at least a week, and where antibiotics are being prescribed only if clear evidence of bacteria has been found (yes, tests would be conducted first). The European Parliament now argues for adoption of prudent-use guidelines to reduce non-essential exposure to antibiotics in human and veterinary medicine, agriculture etc. Basically, the approach of doctors (Polish ones, for sure), pharmacists etc. has to change which could be achieved by providing them with more and better education and training. More comprehensive information should also be given to consumers to make them aware of the harm done by using antimicrobial drugs improperly and they should not be accessible without a prescription.

"The number of resistant bacteria in Europe is exploding. Bacteria travel across borders and are a threat for the whole EU. First of all, we must ensure that the use of antimicrobials for both humans and animals is reduced. But we also need to bridge the gap between rising resistance and development of new antimicrobials by promoting more research and innovation. If we don't take measures now, the growing resistance could threaten our ability to treat patients and could even take us back to the pre-antibiotic era." said Ms Anna Rosbach.

Publishing clinical-trial data

On the 22nd of November a workshop on access to clinical-trial data and transparency was held by the European Medicines Agency. The EMA decided this year to encourage publication of clinical-trial data in order to allow for more re-analysis thereof by stakeholders. However, since this could lead to some practical issues (e.g., regarding patients' data confidentiality) consultations with stakeholders are needed before a specific policy will be established. During the workshop advisory groups were established (participation in them is still open) that would analyse and present their findings by the end of April 2013 on the following issues: protection of patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice, legal  aspects. The pro-active publication of clinical-trial data is expected to come into force on 1 January 2014.