Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published on a draft basis a Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management (PI 054-1 (Draft 1)) developed by the PIC/S Expert Circle on Quality Risk Management (QRM).

This draft Recommendation will be applied on a 6-month trial basis by PIC/S Participating Authorities. The purpose of this draft document is to provide guidance on evaluating and demonstrating the effectiveness of a PQS in relation to risk-based change management. This is in recognition of the fact that the PIC/S GMP Guide requires companies to demonstrate the effectiveness of their PQS and to apply quality risk management (QRM) principles to change control activities. Further information on the background to this Recommendation and the anticipated benefits of this guidance are provided in PIC/S Concept Note (PS/INF 88/2019). This draft document is not open for comments by industry. Formal adoption of the guidance will proceed in accordance with PIC/S procedures on a revised version after completion of the trial-period.

More information is available on the PIC/S’s website.

Germany and enforced parallel importing of medicines

In Germany, health insurance companies are encouraging pharmacies to replace prescribed medicinal products with imports of the same product from other countries at a lower price. The result is that these irreplaceable medicines are not then available to patients in the exporting country.

Under German law, the federation of national health insurance companies concludes a framework agreement with the federation of German pharmacies. This agreement requires pharmacies to save costs on irreplaceable medicinal products by giving preference to cheaper medicines acquired through parallel imports. The system is based on a negative financial incentive for pharmacies (malus). If the pharmacy saves more than the required amount, however, it receives that excess as a bonus. Pharmacies are therefore trying to sell cheaper medicines from parallel import to the greatest extent possible. In July 2019, a new contract increasing the required savings levels from 0.5% to 2% of the price of prescribed medicines entered into force. This doubled the volume of parallel imports. By means of this national legislation, Germany has begun depleting medicine stocks in the countries that have the cheapest prices as a result of lower living standards.

The Commission is asked by Kateřina Konečná, member of the European Parliament representing the Czech Republic, for a written answer if this national law is in line with EU internal market rules and if the Commission is planning to find a legislative solution to the situation, or will it give the Member States a legal instrument that they can use to protect themselves from this practice.

Shortages of medicines in the European Union

According to Directive 2001/83/EC, holders of authorisations to produce medicines are required always to guarantee their availability. However, in practice, it is increasingly common for patients and doctors in the European Union to encounter shortages of certain medicines. This compels them to resort to more expensive medicines, or to order medicines from countries that are not members of the EU and where the same safety requirements do not apply. This has disastrous consequences for patients’ health.

The Commission was asked by Cindy Franssen, member of the European Parliament representing the Belgium, for a written answer on the below:

  1. Is the Commission monitoring whether shortages are genuine rather than being engineered by businesses with the aim of selling a more expensive alternative medicine?
  2. Apart from better coordination between Member States, how else does the Commission intend to overcome the increasing shortages in the short term?
  3. As a follow-up to the mission letter to the new Commissioner for Public Health, what measures does the Commission propose in order to tackle dependence on third countries and to increase the production of medicines in the EU?

The Commission was also asked by Frédérique Ries, member of the European Parliament representing the Belgium, for a written answer on the below:

  1. What specific and realistic recommendations does the Commission intend to make in order to prevent shortages of medicines?
  2. Will the Commission address the obstacles hindering access to essential medicines and resulting in significant price erosion, burdensome regulatory procedures in some Member States and the production of active pharmaceutical ingredients (APIs) being left to third countries?
  3. Is the Commission prepared to set up a high-level pharmaceutical forum bringing together industry, patients, policymakers and other stakeholders to establish strategic recommendations aimed at ensuring long-term access to medicines, while enhancing the competitiveness of the European pharmaceutical industry?

On behalf of the European Commission, the former European Commissioner, Mr. Andriukaitis replied that the Commission is aware of the problem of shortages of essential medicinal products and its negative impact on the European patients. The Commission is following closely the issue and Member States’ and European Medicines Agency initiatives addressing this problem. The reasons of the shortages are diverse and vary from the manufacturing issues to the commercial decisions of pharmaceutical industry. However, the current Commission is not in a position to answer questions related to the mandate of its successor and invites the Honourable Member of Parliament to address the question to the next Commission once it takes office.