EU pharmaceutical package

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The EU pharmaceutical package (also: Pharmapaket or Pharma Package, English Pharma Package ) was a package of measures by the European Commission to improve drug safety in the EU . The main contents were:

The EU pharmaceutical package was presented in December 2008 by the then EU Commissioner for Enterprises and Industry and Deputy Commission President Günter Verheugen and was only partially adopted and implemented. This was preceded by the establishment of a committee (“Pharmaforum”) in 2005, in which the ministers of the EU countries dealt with representatives of the EU Commission and the EU Parliament to develop the content.

The EU pharmaceutical package only concerned medicinal products for human use.

Improve pharmacovigilance

Post-market risk monitoring ( pharmacovigilance ) is generally established at the European level for all drugs in EU countries. This is intended to enable drug risks to be identified faster and better and any necessary measures to be implemented quickly and uniformly across the EU. The range of information on drug risks and risk monitoring is being expanded and made publicly accessible via a web portal.

The reporting channel for observed adverse drug reactions will be shortened and the reporting requirement will be expanded. So have pharmaceutical company reports directly to the European Medicines Agency address (EMA), the uniform for the collection, compilation, analysis and archiving the network EudraVigilance operates, and not, as more previously to the respective national authorities have, which then forwarded the messages . For the serious adverse events to be reported within 15 days , not only those in EU countries, but also those worldwide must now be taken into account. In addition, non-serious adverse effects that have occurred in the EU now have to be reported within 90 days. The obligation to report also includes side effects that occur after improper use (medication errors, misuse); In addition, a distinction is no longer made between expected (known) and unexpected (new) side effects. Patients can also report side effects to the national higher federal authorities themselves. On the other hand, pharmaceutical companies are no longer required to report periodic adverse effects for a number of drugs; The EMA sifts through the scientific literature with regard to certain medicinal substances and records undesirable effects in EudraVigilance.

Risk management plans with a description of the risk management system that the applicant will introduce for the drug in question must be submitted for new authorizations. Authorization holders can be obliged to take risk management measures with and after authorization (e.g. further efficacy and safety studies). Medicinal products that are subject to additional risk monitoring must be marked in the package insert with a black symbol and an explanatory text. A new introduction is the provision of the description of the pharmacovigilance system as a pharmacovigilance master file (Pharmacovigilance System Master File) for the authorization holder instead of the previously usual submission with each individual authorization application.

To coordinate and manage the additional tasks for the European Medicines Agency a Pharmakovigilanzausschuss (is Pharmakovigilance Risk Assessment Committee, PRAC ) established the Pharmacovigilance Working Party ( Pharmakovigilance Working Party, replaced PhVWP). The PRAC is involved in all pharmacovigilance matters for medicinal products authorized in EU countries and supports the Committee for Medicinal Products for Human Use (CHMP) , which is also part of the EMA, and the coordination group of the state authorities (CMDh). The PRAC is also responsible for leading European risk assessment processes .

The basis of the new regulations are the EU Directive 2010/84 / EU of December 15, 2010 ("Pharmacovigilance Directive ") and an EU Regulation (Regulation (EU) No. 1235/2010 of December 15, 2010), both of which have been in effect since January 2011 Kraft and valid since July 2012. It is the most comprehensive change to the EU-wide regulations since it was introduced in 1995.

Combating counterfeit medicines

Pharmaceutical manufacturers have to prove that the active ingredients they use have been manufactured in accordance with the guidelines of good manufacturing practice (GMP). The member states must ensure that only active substances manufactured in accordance with GMP are imported and exported . Only certified active substances with a written confirmation from the exporting country are permitted for import. If pharmaceutical manufacturers discover that pharmaceuticals are actually or presumably falsified on the market, they must inform the authorities immediately.

Prescription drugs have a counterfeit-proof code on the pack, which can be used to check the authenticity of the drug and identify individual packs. Exceptions are possible for prescription drugs if it can be proven that there is no risk of counterfeiting. Conversely, non-prescription drugs can exceptionally fall under the coding requirement if there is a risk of counterfeiting. The original plan that pharmaceuticals remain in the same pack from the manufacturer to the patient did not prevail: Original packaging may continue to be repacked in the course of parallel imports. Parallel importers have to apply a new security code after repackaging.

The EU should have more control over the drug trade over the Internet. An EU-wide uniform logo , which has yet to be determined, will identify trustworthy internet pharmacies.

The basis of the new regulations is the EU Directive 2011/62 / EU of the European Parliament and the Council of June 8, 2011 (“Counterfeit Directive”), which can be implemented nationally within 18 months.

Patient information on prescription drugs

The original draft of the pharmaceutical package from 2008, which included the relaxation of the existing advertising ban for prescription drugs, triggered protests from parliamentarians, health insurance companies, consumer advocates, doctors and pharmacists.

Open advertising for prescription drugs on television, radio and print media remains banned in the EU.

In addition, several restrictions on the pharmaceutical package were considered inadequate. The pharmaceutical package stipulated that pharmaceutical companies should be able to provide patients with neutral and advertising-free information about prescription products. Neutral information is, for example, the texts of the product information ( package insert ), but also other factual information such as changes to the packaging, price information or environmental compatibility. Further product-related medical information, such as information about non-interventional studies, should require prior official approval. The member states complained that such a release would require an enormous additional control effort on the part of the competent authorities without improving patient information. Factual information from the pharmaceutical industry - in addition to the officially approved product information such as the package insert - is not acceptable as long as advertising and information are not clearly distinguishable from one another.

In May 2014, the draft regulation and directive were withdrawn.

literature

Web links

Individual evidence

  1. ↑ Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Safe, Innovative and Affordable Medicines: A New Vision for the Medicines Industry COM (2008) 666 final of 10 December 2008.
  2. ↑ European Commission> DG Health and Food Safety> Public health> Medicinal products for human use> Prarmaceutical Package
  3. ↑ Regulation (EU) No. 1235/2010 of the European Parliament and of the Council of December 15, 2010 amending Regulation (EC) No. 726/2004 laying down community procedures for the approval and monitoring of human and veterinary medicinal products and establishing it a European Medicines Agency with regard to the pharmacovigilance of medicinal products for human use and Regulation (EC) No. 1394/2007 on advanced therapy medicinal products (PDF; 846 kB)
  4. ↑ Directive 2010/84 / EU of the European Parliament and of the Council of December 15, 2010 amending Directive 2001/83 / EC on the creation of a Community code for human medicinal products with regard to pharmacovigilance (PDF; 1.0 MB)
  5. ↑ EMA website: 2010 pharmacovigilance legislation
  6. ↑ Directive 2011/62 / EU of the European Parliament and of the Council of 8 June 2011 amending Directive 2001/83 / EC on the creation of a Community code for human medicinal products with regard to the prevention of counterfeit medicinal products from entering the legal supply chain (PDF; 856 kB )
  7. ↑ European Commission> DG Health and Food Safety> Public health> Medicinal products for human use> Information to patients> Legislative approach