欧盟对德国药品网上销售定价的裁定
出自识林
欧盟对德国药品网上销售定价的裁定
笔记 2016-06-11 Sidley 6月2日，欧盟总法律顾问Szpunar签发意见书，就有关处方药跨境互联网销售的诉讼向欧盟法院（CJEU）提出建议。1 这起诉讼涉及消费者组织试图与德国以外的网上药店合作，使德国患者获得更为优惠的价格条件。德国法律规定，无论这些产品是否在传统的德国药房出售，或者由德国以外的供应商在网上销售，销售给德国患者的医药产品实施统一的零售价格。该诉讼质疑，这种统一价格的束缚是否对德国以外的供应商带来损害，并因此限制了这些供应商对德国的市场准入，违反欧盟自由流通规则。 Szpunar总顾问认定，德国的价格控制对德国以外的药店确实造成了比本国药店更多的影响。由于德国法律禁止德国以外的药店在德国拥有或运营实体药店，本质上给这些药店造成损害。这些德国以外的药店，只能通过邮购或网购方式向德国顾客销售产品，而德国药店可以通过实体店销售，线上销售只是一种额外的销售方式。德国以外的药店准备通过低价或对患者开展有奖销售的方式来抵消上述劣势和展开竞争，但德国的定价限制，阻止它们这样做。从这个意义上来讲，德国法律阻止跨境药店准入。 德国辩称，对于确保全德国药品稳定供应，这样的价格管制是必要的，价格竞争将迫使当地药店降低服务质量。意见书驳回了这些观点，表示将价格管制与“供应持续性”联系在一起“过于牵强”，价格竞争在事实上有可能导致更佳的服务。德国还援引“预防性原则（precautionary principle）”，辩称作为对风险的响应（例如非持续供应），成员国可以实施限制，而“无需等到”预见风险变得完全明朗的事实出现时再采取措施。意见书也驳回了这一辩称，对于涉及人体健康风险的存在或程度存在科学上的不确定情况时，意见书鼓励欧盟法院限制对预防性原则的依赖。对于仅仅涉及旨在解决不确定性的政策选择效率的不确定性，不存在科学上的不确定性的情况，预防性原则不应发挥作用。 Szpunar总顾问进一步强调，举证责任有赖于成员国希望证明限制性措施对公共卫生领域的正当性。在这起诉讼中，他认定德国没有提供任何证据证明，对于保护公众健康，定价措施是一种适当和相称的方式。 如果欧盟法院遵照该意见书，这一诉讼将会创下一个重要先例：如果网上销售是到达当地消费者的唯一方法，原则上禁止统一零售价格。通常情况下，零售价格控制需要严格意义上的证明。抽象地将零售层面的风险提交审断是远远不够的。 1 Case C-148/15 Deutsche Parkinson Vereinigung. 盛德在欧盟法院前代表德国患者组织Deutsche Parkinson Vereinigung。 翻译：识林-Kapok 英文原文 On June 2, 2016, Advocate General (AG) Szpunar issued an Opinion advising the Court of Justice of the EU (CJEU) in a case concerning cross-border internet sales of prescription medicines.1 The case relates to attempts by a patient association to work with an online pharmacy from outside Germany to get better terms for German patients. German law imposes a uniform retail price upon medicinal products sold to patients in Germany, regardless of whether those products are sold in a traditional German pharmacy, or sold online by a supplier outside Germany. The case considers whether this uniform price obligation creates disadvantages for non-German suppliers, thereby limiting their access to the German market and infringing the EU’s free movement rules. AG Spzunar found that the German price control law does affect non-German pharmacies more than domestic pharmacies. He found that non-German pharmacies have a natural disadvantage in that German law prohibits them from owning or operating a brick-and-mortar pharmacy in Germany. They can only sell to German customers via mail/internet order, whereas German pharmacies offer products from physical premises and use online sales only as an extra sales method. Non-German pharmacies are prepared to offset their disadvantage and compete by offering lower prices or patient bonuses, but the German pricing restrictions prevent them from doing so. In this sense the German law impedes access to cross-border pharmacies. Germany argued that its price controls were necessary to ensure consistent supply of medicines across Germany and that price competition would force local pharmacies to lower the quality of their services. The Opinion rejected these arguments saying that the link between the price controls and “consistency of supply” was “too tenuous,” and that price competition was in fact likely to lead to better service. Germany had also invoked the “precautionary principle,” arguing that a Member State can impose restrictions in response to a risk (such as inconsistent supply) “without having to wait” until the reality of the perceived risks becomes fully apparent. The Opinion rejected that argument as well, and encouraged the CJEU to limit reliance on the precautionary principle to cases where there is scientific uncertainty as to the existence or extent of a risk to human health. In cases where there is no uncertainty about the science, but merely uncertainty as to the effectiveness of a policy option aimed at tackling that uncertainty, the precautionary principle should not come into play. The AG further emphasized that the burden of proof lies on the Member State wishing to justify a restrictive measure on public health grounds. In this case, he found that Germany had not provided any evidence justifying the pricing measure as a suitable or proportionate way to protect public health. If the CJEU follows the Opinion, the case would set an important precedent: if online sales are the only method to access local consumers, fixed retail prices are in principle prohibited. Generally, retail price controls require proper substantiation. Abstract references to the risks of competition at retail level will not be sufficient. 1 Case C-148/15 Deutsche Parkinson Vereinigung. Sidley is representing the German patient association Deutsche Parkinson Vereinigung before the CJEU. |