Thursday 23 October 2014

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Health & Consumers


Personal and Private? Correspondence between DG Enterprise and the Pharmaceutical Industry.

Posted by on 19/10/14

Citing Regulation (EC) 1049/2001, I asked last month for access to the following documents:

All communications in any form, and notes or records in any form of communications between DG Enterprise and any pharmaceutical Industry association concerning the policy, draft policy or decision making process of the European Medicines Agency on the issue of access to clinical trial results, after the closing of a public consultation on that issue on 30th September 2013 and before 21st May 2014’

I got a reply on 17th October with a copy of just 6 (yes, six) documents.

Three of the documents were requests to individual officials in DG Enterprise to fill in survey questionnaires relating to access to clinical trial data – one survey with five questions, and one with seven questions sent to two different officials on the same day. The questions and the answers, if any, were not included.

The fourth and fifth documents were a copy of an invitation to join an EFPIA webinar on access to clinical trial data, and a summary of the discussions at the webinar.

The sixth was an e-mail to DG Enterprise dated 10th March 2014. It contained (part of) a letter from the US and EU pharmaceutical associations to four DGs, the EMA, FDA, and US Trade Representative. The letter contained detailed suggestions for the EMA transparency policy and argued that the same principles be applied when implementing the regulation revising the Clinical Trials Directives. The letter also requested the Commission’s assistance in interpreting transparency Recital 20A of the new regulation in the light of other provisions dealing with commercial confidentiality.

And that’s it. According to the letter from DG Enterprise, disclosure of all other dealings between DG Enterprise and the pharmaceutical industry “would undermine the privacy and the integrity of the individual” and was therefore subject to the exceptions in Regulation 1049/2001. This applies across the board, it seems, even to things that DG Enterprise might have said to the industry. No documents at all from DG Enterprise were released – apart from a list of the six documents that were released.

In refusing access to these documents DG Enterprise made no reference to Article 4.6 of Regulation 1049/2001, which states “If only parts of the requested document are covered by any of the exceptions, the remaining parts of the document shall be released”.

In response to requests in other areas, correspondence between industry and commission has been released. What is so different about the dealings between DG Enterprise and the pharma industry? Does DG Enterprise have its own interpretation of Regulation 1049/2001? Do most dealings between DG Enterprise and the industry over an eight month period contain such private or personal information that they cannot be disclosed? Can DG Enterprise not tell us even one thing they might have said to the industry over that period? Is this good administrative practice?

DG Enterprise did invite me to put forward arguments that disclosure of these documents, which I have not seen, would NOT undermine the privacy and integrity of (unnamed) individuals. Not an easy task.

Regulation 1049/2001 is part of EU law and confers certain rights on citizens and others. Those rights must be respected, and the regulation must be applied faithfully, by all EU institutions.

This case isn’t over yet.END

Ebola: Scary? Yes! Significant? No!

Posted by on 13/10/14
While the latest outbreak of Ebola is certainly a tragedy, its use by the media and political activists is sadly opportunistic. This crisis should provide the opportunity for us to consider fast-tracking development programmes in these poor West African countries.

Dalligate: Barroso to the exit, with a toxic legacy

Posted by on 13/10/14
Guest blog post by Bart Staes and José Bové October 16th will be the sad and second, silent birthday of the day the European Commission president José Manuel Barroso gave in to manipulations of the Tobacco Industry by sacking Commissioner for Public Health, John Dalli. 700.000 Europeans that die every year of smoking in the EU and one sacked European Commissioner is enough.

Europa Media launches a web platform on EU-China animal health research and cooperation

Posted by on 06/10/14

No matter how distant your professional expertise might be from transboundary animal diseases (TADs), such words as Ebola, Swine Influenza (pig flu), or Avian Influenza (bird flu) periodically circulate daily news across the globe.

Whether it raises (mostly unjustified) concerns and fears among regional communities, or contributes to increased research and vaccine development funding, it is evident that the subject of diseases that can be transmitted from animals to humans is of high significance for all countries.



Urbanization and settling in previously unexplored areas result in closer contacts with animals and emergence of new transmittable viruses. In addition, globalization may cause rapid and wide spread of diseases. Therefore, cooperation across borders is crucial for disease prevention and control and most importantly for raising awareness regarding risks and treatment of infectious animal diseases and zoonoses[1].

Europa Media is a partner in the LinkTADs project – Linking Epidemiology and Laboratory Research on Transboundary Animal Diseases and Zoonoses in EU and China – co-financed under the Seventh Framework Programme of the European Union. The project is aimed at coordinating research on disease control cycle between experts in Europe and China. Coordinated by the Food and Agriculture Organization of the United Nations (FAO), the LinkTADs consortium includes major scientific institutions in the field of animal health, and consists of five European and five Chinese partners.

Within the framework of the LinkTADs project, Europa Media has recently launched the LinkTADs platform – a web platform dedicated specifically to the EU-China animal health research and cooperation. The LinkTADs platform will serve as a bridge for European and Chinese researchers and is aimed at providing an opportunity and common space for international experts to generate new ideas, discuss ongoing initiatives and start joint collaboration.

We are now encouraging all international researchers studying animal diseases to register on the LinkTADs platform in order to discover cooperation and funding opportunities within ongoing projects and existing initiatives, and contribute to discussions on scientific achievements, discoveries or existing gaps in order to jointly elaborate new project ideas in the field of veterinary research.

LinkTADs platform will also be interesting for anyone, who would like to learn more about TADs and zoonoses, as it includes a section of e-resources on animal health and food safety issues in the field of epidemiology and laboratory sciences in the EU and China. The e-resources section is a thematic library of scientific and analytical materials, collected from open sources. Apart from the in-depth expert analysis, many of the entries include detailed explanations of diseases and their impact on animals and humans written in a comprehensible style.

Visit to learn more about EU-China cooperation in detecting common challenges and elaborating joint methods and instruments for animal disease control and disease prevention.

[1] Any disease or infection that is naturally transmissible from vertebrate animals to humans (WHO definition)

Clearing the Air on Transparency Decisions, and on Industry Demands to the Juncker Commission

Posted by on 05/10/14

At the Ombudsman’s recent conference two points were made that seem to contradict things I’ve said here. It is nice to have a blog to answer back.

I said that the Commission had the final say on EMA’s transparency policy (Article 80 of Regulation (EC) No 726/2004 ). I was immediately contradicted by a member of the EMA, who said that the EMA Board took the final decision “with the agreement of the Commission”. Two members of DG Sanco (at least for the present) made the same point in conversation later. Here is my answer, which is based on the correspondence between EMA and Commission, as released by the Ombudsman. In each case I give the relevant page number in the (171 page) pdf document that you can download from here:

Seven weeks after the end of the public consultation on transparency last year, the EMA presented to the Commission a detailed report of the 27 main industry objections to the proposed transparency policy – under the headings of Patient Confidentiality (6 objections), Clinical Trials Format (3), Rules of Engagement (7), Analysis of Results (4), and Legal Aspects (7) – pages 15-29. This seems to have been before the same material was sent to the EMA Board.

At the EMA Board meeting in December, the representative of DG Sanco said that other commission DGs would be affected by the proposal and should be consulted – page 36

At the Board meeting in March 2014, the Commission said that some other parameters should be evaluated “such as interaction with the TRIPS Agreement and the European patent system” – page 93.

On 20-23rd May the draft policy was discussed in detail with DG Sanco – page 127.

On 28th May Dr Rasi wrote to Director General of DG Sanco requesting the Commission’s agreement to the draft new transparency policy that was to be submitted to the EMA Board – page 146.

The draft transparency policy was discussed again in a meeting in June 2014 between the EMA and DGs Sanco, Enterprise (three representatives), Trade, Research and the Legal Service – page 165.

DG Sanco wrote back on 11th June giving their agreement, subject to certain amendments and conditions – page 169.

To claim that the Board takes the final decision is formally, bureaucratically, pedantically correct but, in the real world, wrong.

Also at the Ombudsman’s conference, the Director General of EFPIA said that the industry association had not requested the transfer of responsibilities for medicines to DG Enterprise or any specific DG. Talking to me later, he said that they had asked that the three Commission units dealing with medicines should be brought together into one, but had never specified into which DG they should be put.

So, where did the industry expect the new medicines unit to end up – in DG Fish? In fact they clearly did not have to specify which DG they had in mind.

The industry clearly asked the new Commission to put together the unit dealing with medicines and medicines safety and the unit charged with promoting the pharmaceutical industry. This is exactly what the entire health sector opposes. No one unit or DG should have responsibility for medicines safety/transparency AND responsibility for strengthening the European pharmaceutical industry. Member states do not normally assign responsibility for medicines to the industry ministry and this should not be done at EU level either. END

‘Save the Bees’ Ban: Who is to Blame?

Posted by on 29/09/14
The recent precautionary ban on neonicotinoid pesticides to save the bees has gone badly wrong in less than a year. Oilseed rape crops are being devastated and Member States are now allowing neonics to be used as emergency measures. Farmers and scientists had warned anyone who would listen, but no one in the European Commission was interested in dialogue. Remember the basic maxim: Never outsource policy-making to campaign-driven activists.

The european drug report 2014

Posted by on 28/09/14

Trends and developments presented to LIBE commmitte on the 24th of september by the Director of the EMCCDDA, Wolfgang Götz.The European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) raises the attention on the emergence of both new synthetic opioids and hallucinogenic substances which are so powerful that it takes tiny quantities to produce many doses. The fact is that a part of these substances are not even illegal, since they are too new and legislators do not even know them. This challenge requires a quick answer and new funds, otherwise we lose the battle form the start.

The picture emerged from the presentation of the Director of EMCDDA is that of a reduced consumption of heroin but an increase in consumption of new psychoactive substances which were reported to the EU Early Warning System. In 2013 81 new substances were notified, leading to 350 the number of substances monitored. This year 72 new substances were reported and this poses a great pressure on the EU Early Warning System.

The new drugs (new psychoactive substances) can be synthetic or naturally occurring substances that are not controlled under international law, and which have the same effects as controlled drugs. Some of these chemicals are imported from suppliers in China or India and then packaged and sold as ‘legal highs’ in Europe.

In 2013 the EMCDDA was very active. Risk assessments were carried out on two substances in 2013, and on other four by April 2014. The result was that these substances often lead to severe toxicity and also death.

Cannabis is still polarizing the public opinion in Europe, thanks also to the regulatory changes in parts of the United States and Latin America with regard to the ways cannabis is available and controlled. In Europe its consumption is steady, even declining among young people but the situation is not homogeneous among Member States. Still, it represents an important revenue for organized crime groups.

The general European market for illegal drugs is stable: cocaine is most used in southern and western countries and amphetamine are prevalent in northern and eastern countries. Last year Europol noted the dismantling in Belgium of the two largest drug production sites ever found within the European Union, which were capable of rapidly producing large volumes of MDMA (3,4-methylenedioxy-methamphetamine). This is a good sign and EMCDDA is closely working with Europol in the fight against these networks.

Mr. Götz also pointed out the important role that internet plays in the drug market because it links manufacturers, suppliers and retailers. Website-hosting and payment processing services are usually based in different countries. There is a growing use of “dark-nets” for the sale of drugs to dealers and consumers and this represents a huge challenge. In 2013 EMCDDA managed to identify 651 websites which were selling “legal highs” to Europeans.

EMCDDA is cooperating with Europol in order to exchange information and provide joint analysis. With regard to this, a first report on the drug markets in Europe was published. They also cooperate with Cepol by providing them training on drug traffic and with many other partners, such as applicant countries to EU and third countries in general. In response to a question of Josef
Weidenholzer, Mr. Götz outlined that they also cooperate with Iran and that this country has very good researchers but cooperation on the law enforcement side is more difficult.

The drug networks do not have borders and this is an issue which concerns every country in the world, therefore there is the necessity to cooperate with everyone who is active in the fight of drug consumption and drug traffic.

In the end, the President of EMCDDA declared that the Centre needs more funds but the trend is that of cutting of funds available for it. In 2014 they experienced a 5% cut of the budget compared to the previous year. He outlined that he is aware of the economic crisis but we deal with organized crime networks which are seeing their profits growing and Europe cannot afford to reduce its efforts in fighting these criminals.

The presentation was followed by the intervention of Michał Boni who raised the problem of standardization of all sources of information, since data coming from different countries have different qualities. He also added that the Centre has to cooperate with agencies of European Commission, such as Health Agency in order to have a faster answer to all these challenges. Mr. Götz answered that there is no problem of communication with the Commission and that they hold 20 meetings per year with regard to methodology and standards and we can say that “now we speak a common language, the best you can find in the world”

Other issues were raised by different member of the Committee, such as the drug legalization and also the need for wide campaigns against drug consumption. Mr. Götz replied that legalization is not being discussed in any of the Member States now but there are some debates at the level of civil society. With regard to wide campaigns, he was very skeptical because there is no evidence that these campaigns actually work. Instead of that, he proposed targeted campaigns promoted in certain areas and within certain groups which are known to be at higher risk with regard to drug consumption.

In the end there was general agreement on the fact that the European Monitoring Centre for Drugs and Drug Addiction carries out a very important task and this should not be underestimated because what is at stake here, is the health of European citizens. For this reason the problem of funding is considered a main issue but there are some positive signs for 2015, also thanks to the work of LIBE Committee.

(Ana Daniela Sanda)

To know more:

European Drug Report 2014: Trends and developments published in May2014 by EMCDDA



Classé dans:COOPERATION INTERNATIONALE, COOPERATION JUDICIAIRE POLICIERE, Lutte contre la drogue, Lutte contre le crime organisé

Making the same mistake all over again: Juncker’s reshuffling of public health portfolios

Posted by on 25/09/14
By Anniek de Ruijter With the reshuffling of the Commission portfolios by president-elect Juncker, major units for EU public health protection move from DG SANCO to DG Enterprise and Industry. The changes to the portfolios come without further explanation and after the deadline for the Parliament to ask written questions has passed. One wonders: what did we learn from the BSE crisis?

More bad news: Mr Juncker replies to concerns on medicines

Posted by on 25/09/14

Mr Juncker has replied by letter to the concerns of the health sector on the transfer of medicines from DG Sanco to DG Enterprise/Internal Market. The letter says that one of the main priorities of the new commission is to create “A Deeper and Fairer Internal Market with a Strengthened Industrial Base” and to that end to establish a new DG for legislation for internal market of products and service (apart from financial services) and including “medicinal products”.

The transfer is therefore part of a wider process to strengthen the European pharmaceutical industry. DG Enterprise will be responsible for strengthening the European pharmaceutical industry AND for medicines, medicines regulation, medicines safety, and the European Medicines Agency.

This is exactly what the health sector opposes.

There is not some large transfer of responsibility for products and services to the new DG Enterprise/Internal Market. Medicines (or “medicinal products,” as the letter describes them) are the ONLY goods for which responsibility is transferred to DG Enterprise.

Food law is a key element of internal market laws but is not transferred to the new super Enterprise DG although that DG is responsible for strengthening the European food industry. Why were medicines singled out for transfer?

(There was a time, as it happens, when DG Enterprise was responsible for much food law but the Prodi Commission transferred that task to a new DG Sanco, so as to separate responsibility for food law from responsibility for promoting the food industry. The second Barosso Commission did the same for medicines.)

General product safety is the responsibility of the new Justice/Consumers DG. This is also an important element in internal market legislation but is not transferred to DG Enterprise. Again, why only medicines?

The letter does say that all proposals for decisions on medicines will be prepared “jointly” (my emphasis) by DG Sanco and DG Enterprise. This may be significant in bureaucratic terms but less so in practical terms. At best, DG Sanco will remain the junior partner , if indeed it can be called a partner at all. With medicines assigned to DG Enterprise in the Commission internal organigramme, DG Sanco will not have the resources to build up the knowledge base, expertise, experience, research data, and ongoing daily interactions with the world of medicines to match those of DG Enterprise.

Remember Glenis Willmott’s experience as rapporteur for the regulation revising the Clinical Trials Directives;
“When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down”. Now it is DG Enterprise which will responsible for implementing that regulation.

(On a wider level, Commission approval is required for all aspects of the transparency policy of the European Medicines and it is the Commission and not the agency that has the final decision on the authorisation of medicines.)

I can think of one excuse for this letter. When there is not a good reason for a decision, or when you do not want to admit the real reason, the only option is to put forward bad reasons.

Given that medicines are singled out for transfer to DG Enterprise, given that this is exactly and precisely what the industry demanded, given that the decision overturns a reform of only five years duration, and given that DG Enterprise is also responsible for strengthening the European pharmaceutical industry I would say something I don’t think I have ever said before. Unless this decision is reversed, patients and consumers cannot have confidence in the regulation of medicines at EU level. END

The ebola outbreak in West Africa is no threat to international peace

Posted by on 25/09/14

On September 18, the UN Security has unanimously passed a resolution, co-sponsored by 131(!) governments, calling the outbreak of Ebola in Guinea, Liberia and Sierra Leone a “threat to international peace and security” and asking countries world-wide for urgent medical personnel and supplies to contain the outbreak.

UN and WHO have waited nine months after the first case had been registered in Guinea at the end of 2013, before alarming the world community on the new outbreak of Ebola, an extremely contagious disease, in three small West African countries.

The UN Secretary General has estimated that $ 1 billion would be necessary to keep the number of cases within the tens of thousands, compared to slightly less than 6000 until now. The US government has pledged to send 3000 military to help the countries contain the disease.

Whatever the outcry and despair, the countries struck by the Ebola epidemics should be able to handle it domestically, if urgently provided with basic medical equipment and hospitals for separating infected patients.

The neighbouring countries – Senegal, Ivory Coast and Nigeria – have been almost completely spared, thanks to their better medical infrastructure and the early closure of their borders. A separate outbreak of Ebola in the Democratic Republic of Congo has been contained by local efforts. Outside Africa there is practically no risk of contagion, let alone epidemics.

The alarm call by the UN Security Council has been belated and excessive. One wonders why it addresses regional health issues falling within the responsibility of the WHO.

With the necessary oversight, advice and assistance from the WHO and organisations like “Doctors without Borders” the three affected West African countries should be able to contain their epidemics without any risk for world peace.

There are far more serious and long-term threats to world peace and security that the UN should address , including climate change.

Eberhard Rhein, Brussels, 21/9/2004


Sports nutrition ads – do they have a place on the pitch?

Posted by on 25/09/14

Whitehouse Consultancy client, the European Specialist Sports Nutrition Alliance, is quoted on top EU food regulation site defending the sector’s products. The defence comes as  two researchers from the Institute of Sport, Exercise and Active Living in Australia argue that sports nutrition products should not be allowed to sponsor sporting events.

To read the article click here.

The Whitehouse Consultancy is one of Europe’s leading public affairs and communications agencies. Its range of specialist services for the food sector can be found here.


Eurodeputati e pesticidi

Posted by on 25/09/14

Sto camminando al piano zero dell’edificio Altiero Spinelli del Parlamento Europeo insieme al mio ex capo F e andando all’infocentre: parliamo della nuova legislatura, degli eurodeputati che non ci sono più e dei nuovi arrivati.

«Ciò che molti MEP (eurodeputati, ndr) vogliono è essere ricordati per il lavoro che fanno» dice F e aggiunge «Questo è difficile nel Parlamento europeo».

«Perché? »

«Perché nel Parlamento europeo non le leggi non prendono il nome dei parlamentari che le promuovono».

A me viene in mente la Legge Merlin ma non dico niente, così, dopo qualche metro in silenzio, chiedo «E che cosa dovrebbe fare un MEP? »

«Dovrebbero specializzarsi principalmente su un argomento e portarlo avanti» F si ferma saluta una persona e poi ritorna al discorso «Come ha fatto Hiltrud Breyer con i pesticidi”.

«L’eurodeputata tedesca che ha fatto vedere quel film francese sui pesticidi nel Parlamento europeo e ha denunciato la loro pericolosità anche per i coltivatori?»

«Sì, è anche quella che ha combattuto per regole rigide sugli OGM in EU ed è stata famosa per questo; si è ritirata dalla politica quest’anno».


Per chi fosse interessato agli effetti dei pesticidi sulla salute, consiglio i seguenti siti:

- (EN)

- (EN)

- (EN, sottotitoli in Italiano)

- (EN)

- (FR) Film “ La mort est dans le pré”:

The pharmaceutical industry against patients, doctors and pharmacists

Posted by on 18/09/14

Joint letters with like-minded organisations are never easy to write, even among friends. Each organisation wants to add its own nuance.Different organisations may have different rules for sign-off on final drafts, and amendments can ping-pong from one to the other. I’ve been there.

Sometimes, however, an issue is so important and clear that a joint position is agreed and action taken in a very short time – as in the case of the 30 health-care organisations that have written to Mr Juncker to oppose the proposal to transfer responsibility for medicines, medical devices and health technology from DG Sanco to DG Enterprise.

And not just any organisations: the signatories include the European representative associations of national organisations of doctors, pharmacists, hospital physicians, hospital pharmacists, health mutuals and health insurance funds, hospital associations, social security funds, cancer leagues, heart foundations, medical bulletins, patients, the elderly, consumers and many others. Offhand, I cannot think of any major European healthcare representative voice that has not signed up – well, the pharmaceutical industry, perhaps, but they have their own agenda.

The editor-in-chief of the British Medical Journal, Fiona Godlee, has also written a joint letter with the review Prescrire, in the same sense.

I don’t think I have ever seen such a wide and immediate agreement between such a diverse range of professionals, patients and consumers on one issue. This is the united voice of the European healthcare sector. Will Mr Juncker listen?

The decision to make the transfer from health to the industry DG seems to have been at the demand of the European pharmaceutical industry. According to an article in Scrip on 12th September:
EFPIA said that commission president-elect Jean-Claude Juncker had “taken on our views and put together all units that are relevant for our business in Europe”. These, it said, were previously spread over three directorates general, SANCO (health), MARKT (internal market) and ENTR.

So now we know. We have the industry on one side on this issue and on the other side the entire health care sector – doctors, pharmacists, patients, hospitals, mutualities, sickness and social security funds, consumers etc. The industry claims to play an important role in healthcare and indeed it does but that role is not always positive. END

A bad start for the New Commission

Posted by on 10/09/14

Some years ago, DG Sanco, the health directorate for public health, took over the lead role for medicines and medical devices from DG Enterprise the industry DG, which was responsible for promoting industry, including the pharmaceutical industry. The change was a good one, enabling a clearer focus within the Commission on medicines as an essential element of health policy.

Now in his line-up for the new Commission, Mr Juncker has announced that the units dealing with medicines, medical devices, and health technology will be moved back to DG Enterprise!

In the new Commission, DG Enterprise will be responsible for promoting the European pharmaceutical industry and for Commission policy on medicines and medical devices. Other DGs will have a say, of course, but DG Enterprise will take the lead and will be the main interlocutor with the industry on medicines and medical devices. This is a good day for the pharmaceutical industry, but a bad day for public health. The industry has great influence across a wide range of government policies but typically rather more influence on industry departments – and this is not to imply any impropriety on the part of DG Enterprise.

One DG should not combine the lead role for medicines policy with the lead role for the promotion of the pharmaceutical industry. This is not the way to achieve clarity in public health policy. The difficult task of balancing the interests of public health and the (legitimate) interests of the pharmaceutical industry should not take place within the one DG (and should not be well hidden from public scrutiny) .

There is also the difficulty of ensuring the right mix of skills within the one unit or DG – combining specialists on public health with expertise on industrial promotion.

This was how the change was announced:

Units SANCO B2 (Health Technology and Cosmetics), SANCO D5 (Medicinal Products – Authorisations, European Medicines Agency) and SANCO D6 (Medical Products – Quality, Safety and Efficacy) move from DG Health and Consumers (SANCO) to DG ENTR.

You can see the full announcement here.

The Commissioner–designate for Health and Food Safety is Vytenis Andriukaitis a former Minister for Health in Lithuania – and a surgeon, but he will not have responsibility for medicines, medical devices or health technology. That will be the task of Elżbieta Bieńkowska, a former Deputy Prime Minister of Poland, who is the Commissioner–designate for Internal Market, Industry, Entrepreneurship and SMEs, to give her full title.

The new Commission-designate must be approved by the European Parliament and I hope there will be strong voices there who think that medicines should be seen first and foremost as a matter of public health policy.

There is still time for the Commission to re-think this appalling decision. END

TTIP: threat or opportunity to public health?

Posted by on 03/09/14
Guest blogpost by By Sascha Marschang, Policy Manager for Health Systems of the European Public Health Alliance (EPHA). It has already been one year since the European Union and the United States began negotiating the “Transatlantic Trade and Investment Partnership” (TTIP) and international agreement sets out to simplify and enlarge trade between the world’s two biggest [...]