Local view for "http://purl.org/linkedpolitics/eu/plenary/2009-01-13-Speech-2-377"
| Predicate | Value (sorted: default) |
|---|---|
| rdf:type | |
| dcterms:Date | |
| dcterms:Is Part Of | |
| dcterms:Language | |
| lpv:document identification number |
"en.20090113.29.2-377"2
|
| lpv:hasSubsequent | |
| lpv:speaker | |
| lpv:translated text |
"Madam President, ladies and gentlemen, the proposals in the so-called pharmaceutical package which I am presenting this evening at Parliament’s request have a common theme. The intention of the package is to strengthen the rights, needs and interests of patients in our healthcare systems.
Finally, the pharmaceutical package includes a proposal for improved patient information. I know that this is a highly controversial issue which we have often considered in this Parliament and I hope that we will succeed in discussing this issue calmly and objectively and without resorting to polemics.
Patients have a right to information and this applies in particular to medicines. Health is one of our most important assets, if not the most important. The significance of health will continue to increase in our aging society. In a democratic society, it therefore goes without saying that patients must be provided with comprehensive information about matters which affect their health.
I must state very clearly, and this really is a fundamental principle of a democratic society, that we do not need to explain and justify the fact that people should be provided with information. Instead, we need to explain and justify the situation when citizens are not provided with information.
Patients are already actively searching for information. All of us will have come across this situation among our friends, acquaintances or even family members, when a seriously ill person or their relatives and friends search desperately, and in many cases these people really are desperate, for information about whether a better medicine or a better treatment is available.
The first place that these people look is the Internet. They come across information from other parts of the world and are not able to tell whether it is product advertising or factual information. In my opinion this situation is both dreadful and intolerable.
I would therefore like to make it absolutely clear that the current situation does not meet patients’ requirements for high-quality information. It also results in discrimination. People who can understand English and can use the Internet have access to information which is unavailable to those people who cannot understand English and cannot use the Internet. These are generally older people and it is particularly important for them to obtain factual information.
As things currently stand in Europe, if a medicine is American, then the information is available, and if it is European, the information is not available. Our considerations are based on the fact that the ban on advertising prescription-only medicines should under no circumstances be relaxed and that there is a significant difference between information and advertising. Our proposal is therefore that certain information should be released and, in particular, the information which has been reviewed by the authorities and can be found, for example, on the package leaflets of medicines. Secondly, this information should only be published on the Internet in written answers to specific questions or in healthcare publications specified by the Member States.
Thirdly, strict quality criteria must be followed and, fourthly, the Member States must put in place effective monitoring mechanisms. The information must be monitored before publication. Exceptions to this will only be permitted in the context of effective systems.
I would like to explain that there is, of course, a grey area relating to patient information and advertising for medical products. Individual patients are not able to see through this grey area in which information of all kinds is made available via media of all kinds, with the media taking editorial responsibility. Very often this information is controlled by interested parties, to put it cautiously, and readers are not able to identify the source of the information or the interested party involved.
I will be working with the media and with the pharmaceutical industry to draw up a code of conduct in order to ensure that this highly questionable practice is brought to an end. However, to achieve this we need to find a better and more modern solution to the problem of patient information.
In our view patients are not merely the subject of services available from healthcare providers or the subject of the financial interests of the pharmaceutical industry. Patients are responsible citizens whose health is their most important asset and who are entitled to have the best and safest treatments and medicines at their disposal. Patients are the subject of healthcare policy.
This package contains very up-to-date and progressive proposals. It draws the obvious conclusions from the increasing importance which citizens place on questions that concern their own health. I hope that I will have the support of the European Parliament for this package. Thank you very much.
However, health or restoration to health is not just a right. It also involves an obligation to take care of oneself by eating healthily, having a healthy lifestyle and playing an active role in one’s own treatment, if treatment is required.
Our proposal for more effective monitoring of the actual effects of approved medicines, for example, presupposes this type of active involvement on the part of patients. If patients do not notify the authorities about anomalies relating to medicines that they have taken, the monitoring process will be a waste of time.
This also applies to protection against counterfeit medicines. Patients can, and should, in future ensure that they are not taking fake medicines by checking that all the safety features which will be required on future packaging are in fact in place. If we believe that active, informed patients play an essential role in healthcare, in monitoring medicines and in preventing the spread of counterfeits, it is hard to understand why patients are not allowed access to information about the most important medicines. For this reason, the pharmaceutical package consists of the following four parts: a political communication and three legislative proposals on the safety monitoring of medicines, on counterfeit medicines and on patient information.
The rapidly growing numbers of fake medicines have forced us to act. The number of counterfeit medicines confiscated at the EU’s external borders increased almost fourfold between 2005 and 2007. If we do not act now, the first deaths will be caused sooner or later. The problem has also affected the legal supply chain for medicines. We have discovered fake medicines at different stages of the supply chain. Each individual case involves thousands of packages and, therefore, thousands of patients are potentially at risk. In future, patients in Europe must be able to have total confidence in the quality of the medicines which they obtain from legal suppliers, such as pharmacies.
Our proposals are therefore as follows: firstly, clear regulations for all those involved in the legal supply chain; secondly, stricter supervision of medicines in transit or for export; thirdly, the latest safety features on medicines which are particularly at risk, including a seal, an identification feature and a barcode to ensure complete traceability for every package; and, fourthly, regulations for the safety monitoring of active substances.
While the proposal was being drawn up, a misunderstanding arose which I would like to clear up once and for all. The proposal’s sole objective is to improve patient safety. It is not intended to prevent a specific form of medicine distribution, such as parallel trade. The sector in question has been responsible for a striking information campaign. In this case you could almost call it a disinformation campaign. However, I would like to clarify once again that the parallel trade in medicines is an activity which is permitted under the EU Treaty and will remain so. Parallel traders simply need to observe the new safety requirements, as do all other participants in the supply chain. No one is being given preferential treatment and no one is being put at a disadvantage.
The legislative proposal on pharmacovigilance, in other words on monitoring approved medicines, will improve patient safety and reduce the unnecessary administrative burden. This is a good example of how less bureaucracy can lead to greater safety. This will be achieved by making responsibilities clearer and reporting obligations more effective. In addition, manufacturers must introduce an efficient monitoring system. Community-wide access to information about undesirable or previously unknown side effects will make Community-wide risk management significantly easier."@en1
|
| lpv:videoURI |
Named graphs describing this resource:
The resource appears as object in 2 triples