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Policy

EAHP joins calls for Juncker to keep pharma responsibilities health focused

19 Sep, 14 | by ltempler

On announcing the team of Commissioner designates he wanted to include in his Commission team for 2014-19, Juncker included a controversial proposal to shift the responsibilities for pharmaceutical regulation and medical devices away from the Directorate General for Health (DG SANCO), and to place these roles into the Directorate General for Enterprise and Industry (DG ENTR).

EAHP joined with European associations representing community pharmacists (PGEU), doctors (CPME, UEMS) and dozens of patient and consumer organisations in calling the proposals misguided and seeking reversal of the suggestion. The 28 organisations believe that the public health focus and imperative in relation to pharmaceutical regulation and oversight could be lost, with DG Enterprise’s prime responsibilities being to commercial interests rather than public health.

The campaign to reverse Juncker’s proposal is led by the European Public Health Alliance (EPHA). More information here.

In the meantime, as previously reported in the EU Monitor, former Lithuanian Health Minister and surgeon Vytenis Andriukaitis is proposed to take the DG SANCO health portfolio. Meanwhile, former Deputy Prime Minister of Poland Elzbieta Bienkowska is poised to take the DG Enterprise portfolio, with expanded responsibilities for pharmaceutical legislation and medical device regulation.

Dates for hearings between the designate Commissioners and the European Parliament have now been scheduled, with Mr Andriukaitis appearing before the Parliament’s Health Committee on 30th September and Ms Bienkowska meeting with the Industry and Internal Market Committees on 2nd October.

EAHP and partners will brief MEPs on key topics of health concern in advance of the hearings in order that relevant issues tot he European hospital pharmacy profession may be raised and highlighted.

This information was originally published on the EAHP website and can be found here

Apps involving medicines should have pharmacist oversight

9 Jul, 14 | by ltempler

The European Association of Hospital Pharmacists (EAHP) has responded to a consultation by the European Commission advising that any mHealth applications linked to the use of medicines must have levels of regulatory oversight, ideally involving pharmacist expertise, in order to ensure their safety.

The European Commission launched a consultation on mHealth in April 2014, asking healthcare professionals and patients for input on the health related applications of smartphone technology. One of EAHP’s key points was that the introduction of new technologies in the hospital setting has been an ever-present reality. Lessons learned include the need to understand the potential positive applications of a new technology at an early stage, and for Governments and health system managers to take a leadership role in achieving their realisation. This lesson, for example, is evident in the difficulties experienced in achieving bedside scanning as a patient safety measure within hospital systems – as medicines still do not typically contain a bar code to the single unit.

Another key point of EAHP’s response was to underline safety needs when applying mHealth to any process involving medicines.

Dr Roberto Frontini, President of the European Association of Hospital Pharmacists, said:

“The implications of a badly designed mHealth application related to medicines use is frightening. All medicines can potentially cause harm if not taken properly. Therefore, when it comes to mHealth apps and medicines, a level of regulatory oversight is required. We recommend pharmacists be involved in both development and testing of such applications.  Indeed, the need for such pharmacist involvement in ICT processes involving medicines was a strong component of the recently published European Statements of Hospital Pharmacy, agreed with patient organisations and other healthcare professionals.

Beyond this, we urge the European Commission to learn lessons of experience. Technology can offer so much. However, without both vision to see potential positive applications, and subsequent coordination, too often the benefits are not realised. We see this, for example, with our ongoing campaign to achieve bedside scanning of medicines in hospitals. Barriers and obstacles have to be identified and lifted. There is an important coordinating role for the Commission in this regard.

Finally, we urge the Commission not to think about mHealth as only having cost-saving benefits. Improved patient safety and patient outcomes must be considered as just as important, if not more so.”

 

This information has been taken from the EAHP website, more information can be found here

Commission seek views on future of mHealth

20 May, 14 | by ltempler

The European Commission is appealing to stakeholders to respond to a public consultation on their Green Paper on mobile health. They especially seek comment on the barriers that are preventing the full potential of mobile health from being unlocked. The deadline for responses is 3 July 2014.

Topics of consultation include:

  • What specific security safeguards in mHealth solutions could help prevent unnecessary and unauthorized processing of health data?
  • What measures are needed to fully realize the potential of mHealth generated ‘Big Data’ in the EU while complying with legal and ethical requirements?
  • What good practice exists to better inform end-users about the quality and safety of mHealth solutions e.g. certifications schemes?
  • The potential contribution of mHealth in constraining and curbing healthcare costs in the EU

EAHP member associations will discuss potential policy in the area of mHealth at its General Assembly in Sofia in June, and make a response reflecting the agreed points from members at that meeting.

This information was originally published on the EAHP website. More detail can be found here 

Consultation opens on European Professional Card for pharmacists

20 May, 14 | by ltempler

The European Commission has opened a short consultation (deadline 2nd June) on technical matters related to the prospective introduction of a European Professional Card for pharmacists.

The system, which emerges immediately from the recently revised Professional Qualifications Directive (January 2014), has the aim of speeding up the time it takes for an individual seeking to work in another EU country to have their qualifications recognized in another country.

The European Professional Card will not come in the form of a physical card, but rather will be an online portal system. An individual will upload relevant identity and qualification documents for recognition by their home ‘competent authority’ (e.g. a professional qualification regulator, such as a chamber of pharmacy). This will then enable them to have an immediately accessible repository of their qualification documentation, verified at their home level, for a competent authority in another country to recognize. It will prevent lengthy exchanges of documentation that can take place at the present time, blamed for some very slow recognition times.

Pharmacy, alongside the medical profession, nursing profession, engineering profession and others, is one of the professional groups the European Commission are minded to give early support to in creating the system.

Although the current consultation is aimed at professional organisations and authorities within EU countries, all interested parties are invited to take part.

The European Association of Hospital Pharmacists intend to make a short response to the consultation offering measured support for the introduction of the European Professional Card for the pharmacy profession, highlighting the need for mechanisms for individuals to be able to include advanced and specialized qualifications, and for the system to be cogniscant of the possibility that individuals could hold qualifications gained from more than one country, throwing up potential definition issues regarding the “home authority” in charge of verifying.

EAHP Members are welcome to review the consultation and consider their own responses.

This information was originally published on the EAHP website. More detail can be found here

Rationing of chemotherapy drugs in Europe a possibility

1 Apr, 14 | by ltempler

News from an EAHP congress seminar has shown that rationing of chemotherapy in Europe is a possibility if the shortages problem is not resolved.

This startling news was revealed by Wolf-Dieter Ludwig, medical director and head of haematology, oncology, and tumour immunology at the Robert Rössle Clinic, Helios Hospital Berlin-Buch, Germany. He followed this statement with the insistence that pharmaceutical companies should be penalised if they fail to register drug shortages six months in advance.

His comments echoed remarks made by Thomas Langebner, chief pharmacist at the Hospital of the Sisters of Mercy in Linz, Austria, that pharmaceutical companies are unwilling to produce generic medicines if they do not make a profit which then leads to shortages.

Dr Langebner said that medicines have a “product life cycle”, going from development, introduction, growth and maturity to eventual decline, at which point companies often develop an exit strategy. He then explained that excessively high prices of new medicines and low prices of mature medicines after their patent expires discourage production of established drugs. However he also explained that these mature drugs are not useless and it is just as essential to secure a supply of these as it is to generate innovative medicines.

Dr Ludwig went further, saying that he believes the supply of older medicines is more important than that of new drugs. This is because many mature cancer medicines cannot be replaced, he explained. He suggested that pharmaceutical companies should be offered financial incentives to keep older medicines on the market. Dr Langebner argued that the price curve needs to be “flattened”, so that there is not such a sharp difference in price once a medicine loses its patent, which would encourage companies to keep producing it.

Read more and answer the medicine shortages survey here

Latest from European Journal of Hospital Pharmacy

Latest from European Journal of Hospital Pharmacy