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
Information to Patients : Consultation (**Updated for November 2008**)
