European Union logo for online sale of medicines

Legal background

The common logo for legally operating online pharmacies/retailers in the EU Member States was introduced by Directive 2011/62/EU (the Falsified Medicines Directive) as one of the measures to fight against falsified medicines.

The Directive gave the Commission a legal basis to establish the design of a common logo as well as the technical, electronic and cryptographic requirements for verification of its authenticity. It is however up to the Member States to determine the specific conditions for the retail supply of medicinal products to the public. Member States may impose certain conditions and limitations, e.g. by not allowing online sale of prescription medicines.

On 24 June 2014 the European Commission adopted the new common logo through the Implementing Regulation 699/2014. Member States had one year from this date to ensure that the provisions on the common logo are applied. Therefore, as of 1st of July 2015, all online pharmacies or retailers legally operating in the EU should display the logo.

The Implementing Regulation was prepared taking into account the results of a public consultation. [A concept paper(52 KB), replies to the consultation]

What is the purpose of the logo?

Falsified medicines are a major threat to public health and safety. The illegal sale of medicinal products to the public via the Internet by retailers operating outside the law is a serious danger as falsified medicinal products may easily reach the public in this way. The logo helps identify the websites which are operating legally. Buying from a legally operating pharmacy or retailer guarantees the safety of the products.

How does the logo look like?

• Technical paper (3 MB)

The national flag and the text are an integral part of the logo. The flag in the middle left side of the logo corresponds to the Member State where the pharmacy or retailer is registered or authorised. Only national flags of the EU Member States as well as those of Norway, Iceland and Lichtenstein are allowed. Therefore, a logo displaying the EU flag, for example, will not be authentic.

How does the logo work?

The logo links to the website of the national competent authority listing all legally operating online pharmacies/retailers. National websites are listed with the European Medicines Agency. By simply clicking on the logo a purchaser of the medicines online will be sent to the entry of the pharmacy on that national list, thus completing the verification process.

The logo can be trusted only if a purchaser, after clicking, is redirected to the entry of that pharmacy on the list of legally operating on-line pharmacies and retailers registered in that Member State on the national authority web-page.

Communication material

• Press release
• Leaflet(464 KB)
• Animation(8 MB)
• Poster(251 KB)
• Quiz
• Safety of medicinal products in the EU 

Source

http://ec.europa.eu/index_en.htm

Early dialogue to support development of medicines for children

EMA’s early interaction meetings encourage consideration of paediatric needs in the early phases of medicine development.

The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early paediatric interaction meetings with medicines developers to stimulate early dialogue on the development of their medicines for use in children. A one-year pilot phase is starting today.

The new initiative aims to encourage discussions on the paediatric needs that could be addressed with a specific medicine well before the submission of a paediatric investigation plan (PIP).

Medicines developers that wish to participate in the pilot phase are invited to provide information on their medicine using a specific form and send it topaediatrics@ema.europa.eu.

In the European Union, pharmaceutical companies are obliged to develop all new medicines also for use in children. The paediatric development is detailed in a PIP that needs to be agreed with EMA’s Paediatric Committee (PDCO).

While assessing PIPs submitted by medicines developers, EMA identified a number of issues which often delay the paediatric development and consequently children’s access to the medicine. Often, development programmes for adults and children are not sufficiently integrated and the possibility to extrapolate the results of studies in adults to children is not always explored to its full extent.

Early discussion between developers, EMA and its PDCO on the overall paediatric development strategy is expected to help medicines developers optimise the development plan for their medicine and ultimately speed up access to the medicine for children.

About the initiative

Following receipt of a request for an early paediatric interaction meeting, an EMA paediatric coordinator and a PDCO representative will be appointed as well as additional participants from other EMA departments or national competent authorities as required. A date for a teleconference with the applicant will then be arranged.

EMA can only consider a limited number of applications during the pilot phase and the Agency will give priority to medicines that address major public health needs.

The procedure will be reviewed at the end of the pilot and may be modified based on the experience gained.

For further information on the early paediatric interaction meetings, see the last question within the section 'Applying for a PIP, waiver or deferral' on Paediatric investigation plans: questions and answers.

Source

http://www.ema.europa.eu/

What happened at eHealth Week 2015 in Riga?

A total of 1334 eHealth experts and 81 exhibitors from across Europe gathered in Riga to exchange knowledge and share best practices as part of the annual eHealth Week conference and exhibition. The presentation slides, photo's and Commissioner Andriukaitis' speech are now available.

The event kicked off with a VIP Exhibition Tour and a Press Conference, led by three representatives: Dr. Guntis Belēvičs, Minister for Health of Latvia, Commissioner Vytenis Andriukaitis and H. Stephen Lieber, CEO of HIMSS. Afterwards they opened the conference together with keynote speaker Toomas H.Ilves, President of the Republic of Estonia.

In his speech, Commissioner Andriukaitis highlighted the timely release of the Digital Single Market: "We must seize the Digital Single Market opportunities to fulfill a vision for healthcare in the 21st century – a vision of a single, universally accessible, sustainable and high quality, eHealth single market for the benefit of all European citizens and healthcare professionals".

He also highlighted the importance of eHealth Week: "By coming together at events such as this and by sharing experiences in the Member States and at EU level, we will drive forward the case for eHealth".

eHealth frontrunner

According to President Ilves, Estonia has been a frontrunner in eHealth: Nearly all prescriptions are issued electronically, and two-thirds of hospitals use eHealth technologies in some way.

Politico magazine wrote that Ilves touted Estonia as a model of how IT in preventive and treatment services can "improve both the welfare of patients and the healthcare system in general." But more widely across Europe, "healthcare is lagging ten years behind when compared to other industries," he said.

Increasing dynamism of EU economy

Head of Unit for eHealth & Wellbeing Pēteris Zilgalvis (European Commission), who was also in Riga, said: "Digital solutions can increase the dynamism of the European economy and deliver benefits to EU citizens." For him, the conference offered the chance to explore how mobile health and eHealth can help EU citizens manage their own health by empowering them, as well "ensuring the sustainability of our health care systems."

During the event, the Nordic countries revealed interesting findings and next steps for them in terms of eHealth. Finland, for instance, announced they will be switching off paper-based prescriptions by 2017, as they “have reached nearly 100% coverage with electronic prescriptions now”, according to Maritta Korhonen, Head of Development in the Finnish Ministry of Social Affairs and Health.

Real impact

Paul Timmers, Director for Digital Society, Trust and Security (DG CONNECT, European Commission), who spoke during the closing plenary said he was rooting for a European eHealth Community which can turn actions into tangible results with real impact for patients. He said: "I am glad to see that the eHealth community is committed to deliver results with real influence in terms of healthier citizens, more efficient and better healthcare services and economic growth and jobs. By joining up forces and learning from each other we can deliver a social and economic return on digital investment in health and social care".

2016: Amsterdam

eHealth Week 2015 concluded with an invitation to join next year’s edition in Amsterdam, during the week of 6 June, in The Netherlands, the country which at that time will be holding the Presidency of the Council of the European Union.

More information:

• Presentations
• EU-funded project press release: "FICHe showcases 40 startups during eHealthWeek in Riga"
• Storify: a collection of #eHW15 tweets
• Photo's of eHealth Week 2015
• Video President Ilves: Recommendations for eHealth

Source

Digital-agenda for Europe

Cannabidiol Given Orphan Drug Designation for NHIE by the FDA

The drug Cannabidiol was recently granted orphan drug designation by the US Food and Drug Administration (FDA) for the treatment of children with neonatal hypoxic-ischemic encephalopathy (NHIE).¹
 
Neonatal deprivation of oxygen during the birth process can lead to the acute or sub-acute brain injury known as NHIE.¹ In the US, the incidence of NHIE is 1.5 to 2.8 per 1,000 births.¹   Inflammatory cytokines, oxidative stress, and cell death all play a role in the disease pathology.² Affected infants may show loss muscle tone, seizures, poor feeding, and a depressed level of consciousness.²  Around 35% of these infants to die in early life, and 30% may suffer from permanent disability.¹  Currently, there are no effective FDA-approved medications to treat the condition.¹
 
Cannabidiol is a non-psychoactive ingredient in cannabis. It is one of a group of compounds, the cannabinoids, which mediate their effects through the cannabinoid receptors. ³ Several studies have highlighted the potential of cannabinoids as neuroprotective treatments in ischemic brain damage, perhaps partly because of their anti-inflammatory and antioxidant properties.⁴
 
Since 2008, GW has been researching the neuroprotective effects of Cannabidiol in animal models of NHIE. This work has shown that Cannabidiol reduces neurologic disability in several models of newborn animal brain hypoxia. GW expects to submit an Investigational New Drug Application (IND) in mid-2015 for their intravenous formulation of CBD. The company expects to begin a Phase 1 trial in the second half of this year.¹

"This orphan drug designation for Cannabidiol for the treatment of newborn children with neonatal hypoxic-ischemic encephalopathy follows several years of pre-clinical evaluation," GW’s Chief Executive Officer, Justin Gover, stated in a press release.¹ Potentially, Cannabidiol might be approved for orphan drug status for other uncommon medical conditions, especially those with an inflammatory component.³ Mr. Grover also noted, “GW continues to explore the opportunity for the development of cannabinoids in rare pediatric conditions characterized by significant unmet need.”¹

References

1. GW Pharmaceuticals receives orphan drug designation from FDA for Cannabidiol for the treatment of neonatal hypoxic-ischemic encephalopathy [press release]. http://www.globenewswire.com/news-release/2015/04/24/728108/10130593/en/GW-Pharmaceuticals-Receives-Orphan-Drug-Designation-From-FDA-for-Cannabidiol-for-the-Treatment-of-Neonatal-Hypoxic-Ischemic-Encephalopathy.html. Published April 24, 2015. Accessed May 3, 2015.
2. Fatemi A, Wilson MA, Johnston MV. Hypoxic ischemia encephalopathy in the term infant. Clin Perinatol. 2009;36(4):834-838. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2849741/. Accessed May 3, 2015.
3. Nagarkatti P, Pandey R, Rieder SA, Hegde V, Nagarkatti M. Cannabinoids as novel anti-inflammatory drugs. Future Med Chem. 2009;1(7):1333-1349. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2828614/. Accessed May 3, 2015.
4. Alvarez FJ, Lafuente H, Rey-Santano MC, et al. Neuroprotective effects of the nonpsychoactive cannabinoid cannabidiol in hypoxic-ischemic newborn piglets. Pediatr Res. 2008;64:653-658. http://www.nature.com/pr/journal/v64/n6/full/pr2008260a.html. Accessed May 3, 2015.

Source

http://www.raredr.com/articles/Cannabidiol-Orphan-Drug-Designation-NHIE 

The Government of Ireland has approved a new Bill to provide a Universal GP service

Minister for Health Leo Varadkar and Minister of State for Primary & Social Care Kathleen Lynch have received Cabinet approval for the Health (General Practitioner Service) Bill 2015, and agreement that the Bill should be published and introduced to the Oireachtas.

“This phase in the introduction of a universal GP service for the whole population will see free GP services extended to all persons over the age of 70, regardless of income or means. In tandem with separate plans for the under-sixes, this will ensure that the youngest and the oldest have access to GP care without fees. This is a significant step on the way towards universal health care,” Minister Varadkar said.

Minister Lynch welcomed the Government decision saying:

“The first two phases covering the over-70s and the under-sixes will ensure that our oldest citizens and the parents of our youngest can go to their GP, focusing on their health and not how much the visit will cost.”

Subject to the legislation being passed by both Houses of the Oireachtas, the objective is to have a universal GP service for over 70s in Quarter 2 of this year. This is proposed to coincide with the introduction of the under six service.

The Government’s Statement of Government Priorities 2014-2016 reiterated the commitment to the introduction of a universal GP service for the entire population, in line with the Programme for Government.

The Government has prioritised the under sixes and over 70s in the first two phases of the roll-out of universal GP care. The second phase of introducing a universal GP service will cover all persons aged 70 years and over. It is estimated that about 36,000 over 70s currently pay to attend a GP as they are not covered by a medical card or a GP visit card. The cost to the Exchequer of the proposed legislation for a universal over 70s GP service is estimated at €18 million in a full year.

This service will be provided under the existing GMS GP contract. Negotiations on a contract to facilitate the extension of free GP care to all children under the age of six are at an advanced stage between the Department of Health, HSE and the IMO. Contracts will not be issued pending the conclusion of negotiations.

Source

http://health.gov.ie/blog/press-release/universal-gp-service-for-everyone-over-the-age-of-70/

Annual IHE-Europe Connectathon, Luxembourg 20-24 April 2015

The 2015 IHE-Europe Connectathon, organised in cooperation with IHE-Luxembourg and will take place in Luxembourg on 20-24 April 2015.

The IHE-Europe Connectathon provides a unique opportunity for vendors to test the interoperability of their  products in a structured environment with peer vendors. Participants test against multiple vendors using real world clinical  scenarios following IHE Integration Profiles specifications.

The annual IHE Connectathon affords all companies, large and small, the opportunity to test their own products, across a variety of domains includingRadiology, Cardiology, Pathology, Patient Care Devices, Patient Care Coordination, Pharmacy, Laboratory, and IT Infrastructure, along with those of their peer vendors.

Introducing testing of the new Dental domain with integration profile Secure Exchange of Dental Information (SEDI)

The last two years have seen national, regional and hospital tender procedures demand current independent demonstrations of IHE profile implementation competence by vendors and an increasing number of buyers are turning to the IHE Product Registry and Connectathon results pages which list Connectathon results, as part of their decision making process.

IHE-Europe published a Whitepaper on Connectathon, which explains in detail what the Connectathon is and how it is done.

The 15th Connectathon organized concurrently with the Congress Med@Tel which will make announcements on "Pharmacy and m / eHealth". Here, for your reference, the titles, authors and abstracts:

Pharmacy and m / eHealth
Chair: Jamie Wilkinson, Director of Professional Affairs, Pharmaceutical Group of The European Union

Presented in collaboration with the Pharmaceutical Group of the European Union


m / eHealth in Europe - The Pharmacy Perspective
Jamie Wilkinson
Director of Professional Affairs, Pharmaceutical Group of The European Union (PGEU), Belgium [Abstract]


mHealth Tools Supporting Pharmacists' Key Roles: Selected Examples on From Around The Globe
Zuzana Kusynova
International Pharmaceutical Federation (FIP), The Netherlands [Abstract]



A Pharmacy-Led Medication Adherence Monitoring Program in Italy: A Pilot Study With Interactive Monitoring Service
Fulvio Bruno, Mauro Centola, Erika Nerini
FBCommunication, Italy [Abstract]



Netcare: Videoconsultation in Swiss Pharmacies: An Example Where IT Facilitated Collaborative Practice
Dominique Jordan
pharmaSuisse, Switzerland [Abstract]



ePrescription and EHR: A SYNERGIC Strategy to Provide A Wide Range of Services for The Citizens
Federica Sandri, Francesca Vanzo, Sara Valongo, Claudio Saccavini, Claudio Dario
Arsenal.IT, Italy [Abstract]



European Pharmaceutical Students' Association Perspective on mHealth
Lucas Besson
European Pharmaceutical Students' Association, Belgium [Abstract]

Digitalcare Farma: A New Approach to The Pharmaceutical Care
Roberto Tobia
Federfarma, Italy [Abstract]



An IT-Solution for Public Display of Stock Levels in Swedish Pharmacies
Robert Svanstrom
Swedish Pharmacy Association [Abstract]



Smart Technologies in Disease Management- What do Patients Think;
Reem Kayyali, Bassel Odeh, Nada Philip, Shereen Nabhnai-Gebara
Kingston University, UK [Abstract]



A Brief Report about The Application of telepharmacy in Pharmaceutical Care
Marlise Araujo dos Santos
School of Pharmacy, Pontifical Catholic University of Rio Grande do Sul, Brazil [Abstract]



IT Solution for Pharmaceutical Interviews in French Pharmacies
Kevin Dolgin
Observia, France


Integrating Hospital Pharmacy and Community Pharmacy - Facing The Challenge With IHE Interoperability Profiles
Leonidas Tzimis
EAHP (European Association of Hospital Pharmacists), Greece
IHE Pharmacy Co.-Chair for Users [Abstract]

The entire program can be viewed HERE .

Resources

http://connectathon.ihe-europe.net/ 

http://www.medetel.eu/index.php?rub=educational_program&page=program#Mon