**Update September 2009** European Parliament begins its discussion on the pharmaceutical package
The European Parliament has begun discussing the Pharmaceutical Package in the ENVI and the IMCO committee in their first session since the introductory committee meeting in July 2009. The Pharmaceutical Package, released by the Commission in November 2008, could not be discussed in the previous legislature due to a lack of time.
On 1 September 2009 Günter Verheugen, Vice President of the Commission and Commissioner for Enterprise and Industry presented the Pharmaceutical Package to the Environment, Public Health and Food Safety Committee (ENVI). The Package was presented along with several other Commission initiatives that the European Parliament will have to discuss in the coming term such as the banning of incandescent light bulbs and a review of carbon leakage. He also made a plea to the Parliament not to follow the Council’s proposals to cut the budget on the REACH program.
The Commissioner had already presented the Pharmaceutical Package to the previous ENVI Committee (See **Update February 2009**) and did not talk at length on it this time. Mr Verheugen initially brushed over the two parts of the package, Counterfeiting and Pharmacovigilance that he considered as solid and focused on the most controversial part, Information to Patients.
The Vice President hit back at his critics by saying that in producing this proposed legislation, the Commission had not acted in the interests of the pharmaceutical industry. He said that he was ’’more convinced than ever’’ that it is in the interest of patients to have more information. The ’’users’’ of health information do not have access to information that can be checked for objectivity. With an ageing population, the importance of health is increasing and with it are the possible ways to access information.
Drawing on his experience as a journalist, Mr Verheugen said that the difference between advertising and information can easily be defined, saying that journalists make this distinction all the time. He referred to cases when the current ban on advertising medicinal products is circumvented such as in health pages in magazines as ’’weak points’’ that we must protect patients from. The Commissioner did not rule out the possibility of introducing neutral sources for information even though this is not expressed in the legislation. Mr Verheugen closed by saying that the Czech and now the Swedish Presidencies had refused to discuss the proposals on Information to Patients and that it would be passed on to the Spanish Presidency in 2010. He said that there is a big gulf in the Council between those who are in support of the proposals and those who are vehemently against it.
When MEPs had the opportunities to ask questions there were mixed responses. Francoise Grossetete (EPP) felt that the issue of Counterfeit medicines was very pressing and that it needed to be talked about urgently. She questioned whether the Commission’s proposals were enough and suggested that more stringent measures on re-packaging are required. Dagmar Roth-Behrendt (S&D) said that she could not understand why, when people hear information, they immediately think advertising. She said that she was generally in favour of the proposal and that it is a ’’scandal what the Council have done.’’ Cristofer Fjellner (EPP) Swedish MEP and Rapporteur of the Information to Patients part of the pharmaceutical Package took the floor saying that this debate has been going on for ten years now and still patients are not getting the information they need. He said that he was very happy that the proposal has been brought to the table but suggested that it needs some work. Frederique Reis (ALDE) said she was ’’delighted’’ with the proposal but would like to see mention of a ’’dedicated website’’ for independent information.
Jorgo Chatzimarkakis (ALDE) made it clear that he wanted to end this debate, he said that we have discussed this issue ten times before and have never got anywhere. He said that we are trampling people’s rights into the ground and we are acting like this never been talked about before.
Other MEPs remained sceptical about the proposals. Peter Leise (EPP) said that the proposals suggested by the Commission on ITP provide no guarantee at all that advertising will be avoided and all the proposals do is change definitions, which is dangerous. Zoltan Balczo (NI) questioned where the initiative for the package was coming from ? He said that there is a lot of money behind advertising in pharmaceuticals and this is impacting on the type of legislation that is being produced. Mr Balczo said that ’’Brussels’’ want to get involved too much, rules are needed but it is not up to ’Brussels’ to decide what is advertising and what is not, he suggested that an ethical body should be set up to decide. Pilar Ayuso (EPP) said that there is a lot of information already out there but we need to bring it down a level to a level that people can understand. Linda McAven (S&D) Rapporteur for the Pharmacovigilance part of the Package said that independent information is what is needed not information from the manufacturer as this is bound to be biased.
Matias Marisa (GUE), Rapporteur for the Counterfeit medicines proposal, focusing on her topic, said that times have changed and it is time to start thinking about the victim, counterfeit medicines are a genuine public health threat. She said there needs to be traceability throughout the system, we need a clearer definition of what is meant by a counterfeit medicine and that we need to look beyond the active ingredients and look at the other ingredients such as the packing substances.
The Internal Market and Consumer Protection Committee also discussed the Pharmaceutical Package but in a little less detail. The Rapporteur for the Information to Patients part of the package, Cristian Silviu Busoi (ALDE) introduced the proposed Directive and Regulation saying that that he welcomed the legislation and sincerely believed that ’’better informed patients can make better decisions’’. He said that there is unequal access to information across the EU and while he understands some people’s reservations towards industry provided information, he thinks that the industry knows their product best and is therefore in a good position to provide information. Mr Busoi also said that although prior approval of information has some benefits in terms of consumer protection it also carries with it certain censorship implications.
The responses from MEPs in the IMCO Committee were less mixed and generally less positive than in the ENVI Committee, Catherine Stihler (S&D) said that the issue was not that patients need information it is who provides it and the inherent bias that comes with information from industry, the difference between information and advertising cannot be easily defined. Evelyne Gebhardt (S&D) expressed surprise that people think that the pharmaceutical industry should be providing information to patients. She also said that information on clinical trials should be available and the text that the Commission presented is full of jargon, there must be a better way of doing it. Christel Schaldemose (S&D) also said that there is no doubt people want more information but she is convinced that providing that information should be independent. She felt that the Commission should have thought about this proposal longer and harder before bringing it to the table.
António Fernando Correia De Campos (S&D) a Portuguese MEP, new to the IMCO committee, said that while patients need understandable information, we should not oversimplify it. The key to this legislation is that any information that is provided must remain independent and free from advertising. He said we need a three way consensus is needed between the government, the users and the industry in terms of providing information.
In response to the concerns raised, Martin Terberger of the European Commission (DG Enterprise and Industry), said that the proposals on Information to Patients need improvement and that he hoped the Commission and the Parliament could work together. The proposals try to ensure a balance for the level of information the industry can provide, clarifying the difference between information and advertising. The Proposals aim to improve the quality of the information available and to improve patient access to that information and improve the level of information provided by the National Competent Authorities.
Mr Busoi rounded up the discussion by saying that, indeed industry should not be the only source of information but they should be involved and with prior authorisation on the information they can provide. Many Member States have systems in place already that provide information to Patients, all the proposals are trying to do is harmonise those systems of information provision, thus bringing about equal access across the EU. He encouraged the Committee to debate this issue for a long time and did not believe that a quick fix is possible and besides the ENVI Committee is leading this so they will have to deliver their report first.
**Update February 2009** Gunther Verheugen addresses Parliament
On Tuesday 17 February 2009, Gunther Verheugen, European Commissioner for Enterprise and Industry, addressed the European Parliament’s Environment, Pubic Health and Food Safety Committee. In his 45-minute speech, Mr Verheugen gave an overview of all the DG Enterprise measures currently being discussed in the Parliament at the moment.
The Commissioner talked at length on the Pharmaceutical Package. He said that the pharmaceutical industry is a particularly "dynamic sector" and that it is particularly important for our "democratic development." He went on to say the health and safety of citizens is an absolute rule over competitiveness in the pharmaceutical market. Commissioner Verheugen said that health is DG Enterprise’s primary concern when it comes to the pharmaceutical industry.
Mr Verheugen said that the trade in counterfeit medicines is "rampant" and that the problems are more widespread and serious than solely the issues of security around internet pharmacies, as some have suggested. The Commissioner said that he wanted to instill confidence in pharmaceutical products and that patients need to feel safe in the knowledge that the products they are taking are safe and genuine. In order to achieve this he said that the traceability and safety monitoring must be improved and that the proposals on counterfeiting in the Package aim to achieve this.
On Pharmacovigilance, the Commissioner talked about the need to monitor already approved pharmaceuticals. He said that we need to be aware and able to deal quickly with undesirable effects of pharmaceutical products.
Mr Verheugen went on to talk about information to patients, he said that patients need to become actively involved in their treatment and that health is one of our "most important possessions." He said that we need to be informed about the drugs that we take and most of the information that is sought is online. Patients need to be sure that this information is good information and not misleading. Mr Verheugen went on to say that the status quo will not meet patients’ demands for information and that “Information to Patients is part of democracy.” The Commissioner said that he believed a distinction could clearly be made between information and advertising, but only the information that has been approved by authorities. How Member States choose to implement this legislation will be up to them and they will have the full support of the Commission.
February 2009 Rapporteur holds first Exchange of views
On Tuesday 10 February, the Committee on the Environment, Public Health and Food Safety (ENVI-ITP) held a first exchange of views on information on products subject to medical prescription.
The Rapporteur, Christofer Fjellner (EPP-ED, SE), intorduced the proposals, stating there are three points they should agree on :
Empowerment of patients
Strengthening compliance
No direct to consumer advertising
Mr. Fjellner argued that the approach to patients must be put in a broader perspective ; the healthcare system has changed from ’one-size-fits-all’ diagnosis and treatment to a more individual one where patients are more involved in their treatment. Moreover, he stated that patients were seeking more information and they should not be stopped as this information is their right. Therefore, it is crucial to respond to patients rights and needs by providing safe and accurate information.
The biggest challenge is to define the difference between information and advertisement. Furthermore, he claimed that clear distinction between push and pull information was lacking in the proposal. Finally, he wanted more information about public-private partnerships and stated that the proposal should represent a less industrial perspective, but a more patient focused.
January 2009 Rapporteurs announced for Pharmaceutical Package
The Parliament have appointed a rapporteur for two of the three legislative proposals in the Pharmaceutcal Package. For Information to patients the rapporteur is Christofer Fjellner EPP-ED and for Counterfeit medicines, Adamou Adamos NGL/GUE.
The Pharmaceutical Package is being considered in the Environment and Food Safety Committee (ENVI). As the final Committee date before the June 2009 elections is 31 March 2009, it is highly unlikely any agreement will be made in this Parliament.
December 2008 Pharmaceutical Package finally released
Following long delays and much anticipation from industry and health campaigners alike, the European Commission finally adopted the Pharmaceutical Package on 10 December 2008.
The Package contains four measures, three of them legislative, Pharmacovigilance, Information to Patients and Counterfeit medicines and one of them a Communication on the future of the pharmaceutical industry.
Due to some successful work the draft proposals on Information to Patients are much improved from previous versions, for example : prior approval of all information by a competent authority has been included and ’general’ printed media (newspaper, magazines etc...) has been excluded.
However there are still considerable problems and work will have to be done to ensure that they do not impact negatively on citizens.
EPHA has sent out a press release by way of a reaction to the adoption of the proposed legislation on Information to Patients
please find press releases form Health Action International (HAI) and the Pharmaceuticals Group of the European Union (PGEU).
EPHA actions on the Pharmaceutical Package : Information to Patients
The initial release date was put back from 21 October 2008 to 26 November 2008, and it now looks as though it will be pushed back even further. This is due to problems with the Information to Patients and Parallel Trade elements of the package. Commissioner Vassiliou (DG SANCO) has been pushing for changes to the Information to Patients proposals with the support of the public health community.
On Monday 10 November 2008, the EPHA Secretariat in conjunction with AIM, AGE, EATG, BEUC, ISDB, Medicines in Europe Forum and HAI sent a joint letter to Commissioner Androulla Vassiliou. The letter was intended to encourage Commissioner Vassiliou to stand firm with her position towards the Information to Patients part of the Pharmaceutical Package that was due to be released on 26 November 2008.
This letter was quoted in the European Voice on 19 November 2008.
Following this, on 19 November 2008, EPHA, working with several EPHA members and other partner organisations, co-signed and sent another letter related to the launch of the Pharmaceutical Package (planned on 26 November 2008) to Commission President Barroso and the press.
The letter warned the College of Commissioners that various parts of the Pharmaceutical Package (Counterfeit Medicines, Pharmacovigilance and Information to Patients) should be reconsidered. It called for the different parts of the Pharmaceutical Package to be unbundled, as the separate parts should be considered individually given that they deal with different issues.
The second letter was more widely reported including by Reuters News and various other news sources.
The release date has now been put back to 10 December 2008.
For more information please visit DG Enterprise’s website
Background
The EU Directorate General for Enterprise and Industry is preparing the Pharmaceutical Package, this contains 3 main legislative proposals : Counterfeit Medicines, Pharmacovigilance and Information to Patients. The provision of information to patients has been under discussion at European level for a number of years. The report on ’current practices with regard to the provision of information to patients on medicinal products,’ released in December 2007, recommends that information on medicinal products is harmonised within the European Union (EU) in order to ensure that all patients have equal access to information on medicinal products.
DG Enterprise and Industry states the purpose of the proposal is to ensure that all EU citizens have access to good-quality, objective, reliable and non-promotional information on prescription-only medicinal products. DG Enterprise also states that the Pharmaceutical industry should be the ones to disseminate this information.
However many NGOs, public health campaigners and even DG SANCO have claimed that it is not possible for industry to provide completely non-promotional or non-biased information on their products.
The other parts of the package, initially thought to be less troublesome, have caused a great deal of controversy as well. The counterfeit medicines proposals (aimed at fighting the spread of counterfeit medicines) which would bring an end to the practice, legal under current competition law, known as parallel trade. Parallel trade allows drugs to be removed from the package, repackaged and then sold on, often at a lower price than the original. This practice has been called unfair by pharmaceutical companies and is currently the focus of a large corporate and legal fight.
For more information
Joint Letter to Vassiliou
Joint Letter to Barroso
EPHA related articles
