Incentives for micro, small and medium-sized enterprises (SMEs)
Micro, small and medium-sized enterprises (SMEs) play a vital part in the European Healthcare Industry. They are an excellent source of entrepreneurial skills, innovation and employment. Within the European Union, approximately 23 million SMEs provide 75 million jobs across all industries.
In August 2014, an Emergency Committee meeting, under the International Health Regulations (2005) regarding the ‘2014 Ebola Virus Disease (EVD) outbreak in West Africa’ was held, with WHO later releasing a statement saying that this epidemic had reached the status of Public Health Emergency of International Concern.
Resolving issues in relation to public health or community interest
The Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing opinions on behalf of the European Medicines Agency (EMA) for any issues or questions regarding veterinary medicines. The CVMP referral procedure is used to resolve any issues that may be raised in relation to a veterinary product’s impact on public health or in cases where community interest is called into question.
A referral can be initiated for a number of reasons, as outlined below, under EU pharmaceutical legislation for veterinary medicines (Directive 2001/82/EC, as amended):
Most Common referrals:
Article 33: Mutual-recognition procedure (MRP) and decentralised procedure (DCP) referral
Article 34: Divergent decision referral
Article 35: Community interest referral
EU legislation to combat an increasingly significant problem
The most commonly used definition for Falsified Medicines, describes them as deliberately and fraudulently mislabelled medicines with respect to identity and/or source. Falsified medicines do not meet the legal prerequisite quality or safety standards, and subsequently put at risk the health of millions of patients who take for granted safe and effective prescription drugs.
Pharmaceutical falsification of medicines is a lucrative and sophisticated business, and it is gradually becoming a significant global problem. The success of the business can be attributed to increased commercial use of the internet. Rogue internet drug websites are the most frequent way that people purchase falsified drugs. These websites bypass the regulatory safeguards that store-based pharmacies must follow, for example the need for a prescription. These websites also appeal to the customers as they offer cheaper medications, and there is also a sense of anonymity when making a purchase online.