Healthcare Distribution: The Impact of Overregulation

By SME Europe

On 6.12. SME Europe of the EPP hosted the Working Breakfast on: Healthcare Distribution: The Impact of Overregulation. Welcome remarks were made by Dr. Horst HEITZ, Executive Director of SME Europe of the EPP. He then gave over to Dr. Paul RÜBIG MEP, Honorary President of SME EUROPE, Committee on Industry, Research and Energy, Chairman of STOA for the moderation and the speech. After that Jack MCKEIVOR from the European Entrepreneur spoke on behalf of Mrs. Elisabetta GARDINI MEP. Afterwards René JENNY, President of GIRP – European Healthcare Distribution Association made an Introduction and Lothar JENNE, Managing Director and Co-Owner of Max Jenne Arzneimittel Grosshandlung KG was Keynote Speaker. The Impulse Statement came from Arne GERICKE MEP, Committee on Employment and Social Affairs.


Dr. Heitz kicked off the event by emphasizing that SMEs are the backbone of the European Economy and that their development should be supported. After that, he eloquently introduced all panelists, welcomed the guests and gave the floor to MEP Rübig.


Mr. Rübig MEP explained that healthcare is a valuable asset for everyone in the society and that the quality of medical products and services should be secured in order to offer a good healthcare system. He outlined that smart regulation is necessary to support the SMEs in Europe.


Mr. McKeivor held the welcome remarks on behalf of MEP Gardini, who was unfortunately unable to join the event. He emphasized that SMEs need more clarification concerning the Good Distribution Practice (GDP) Guidelines published by the European Commission in 2013. Some points, like for example maintenance, safety and quality, need a more pragmatic solution. The key importance is to ensure that the quality and integrity of medical products are maintained and SMEs are supported during the entire supply chain.


Mr. Jenny kicked off by stating that the idea of smart, pragmatic and rational legislation has been of growing importance to the healthcare distribution sector. In consideration of this legislation he outlined that the Guidelines published by the Commission put a heavy burden on SMEs. As EBIT profits are low, ranging from 0.5% and 1.5% return on sales, the extra costs coming with the regulations introduced through the guideline could end the business of some SMEs in the sector. Mr. Jenny believes that smarter regulation could be possible.


Mr. Jenne began his keynote speech by pointing out that the way pharmaceutical wholesalers do business is as important as the goods we trade. He outlined that rules are indispensable in a developed, fair and orderly society and wise decisions should be made to ensure that the well-being of everyone is taken into account. Therefore, he stated, that his statement must not be understood as opposing such rules. However, it should be allowed to expect that rules are appropriate, practice oriented and balanced in accordance with their intended purpose. In the new guideline, some of the regulations tend to lack substance, leaving room to interpret, others are very difficult to achieve and some don´t take into account the diverging implementations in the EU Member states. The last point refutes the picture of a unified Europe und unevenly divides burdens between member states.


Mr. Gericke MEP outlined the importance that family businesses are partial to fair and smart regulation, leaving them enough space to thrive and prosper. Family businesses are the backbone of the German and European economies and should have regulations not endangering their business and value to our society. He stated that family businesses should be regulated, but in a just manner.