Pharmaceutical & Health Care Politics

European elections 2019: Health is developing into a main topic

So far, most major health issues have been part of the competence of EU Member States. It is not uncommon for individual
states to vigorously reject attempts by the European Commission to assert more control. These circumstances often make it
difficult to obtain results in the context of legislative processes. The disputes between national and European levels regarding
the evaluation of the value of medicines is only one of many examples. For this reason, an increased number of citizens
and politicians are in favour of the EU’s expansion of power at public health level.

The latest Eurobarometer reflects a clear trend

Around 70 percent of voters want the EU to intervene more when it comes to their health care. This is one of the key findings
of the Standard Eurobarometer 2018 and was supported by similar findings of the Special Eurobarometer, that provides indepth
thematic studies. However, the question remains what it means when respondents indicate by a large majority that they want
the EU to do more? This does not necessarily mean that they want Member States to have less competence.
Some experts interpret this result as a call for more cooperation between Member States and the Commission.

Will there be a Directorate General for Public Health in the future?t

The departure of the United Kingdom will, in addition to reducing seats in the European Parliament, likely reduce a Commission
post. In recent months, it has occasionally been suggested that the Directorate General for Health and Food Safety (DG SANTE)
could be spared. The proponents of this proposal argue such a step could enable cross-departmental cooperation in order to
promote overall effectiveness with regards to public health issues. However, some EU parliamentarians have already objected to
this proposal.  In addition, a coalition of 28 different health care organizations has teamed up to promote the appointment of
a vice president for health in the future.

Health as the central issue of the upcoming European elections

The tension between the EU and the member states in terms of differentiated approaches and opinions in the healthcare sector
will be a major issue in the coming EU election in 2019. Various candidates have already put health policy issues on
their campaigning agenda. Manfred Weber, the leading candidate of the European People’s Party, who will run for the Office
of the Commission President campaigns for a double investment in cancer research by 2024. Other candidates have indicated
that they will push topics like security of patient data or disease prevention in the centre of their campaign.

New safety features for medicines sold in the EU are the cornerstone
of the European Falsified Medicines Directive

Since February 9, new regulations have been introduced regarding the safety features (Supplementing Directive 2001/83/ EC) of prescription medicines sold in the EU. This entry into force is the long-awaited final step of the EU’s Falsified Medicines Directive (FMD). After years of preparation, the member states of the EU are now well-equipped to fully fight the distribution of counterfeit medicines.

The extend of falsified medicines in the EU

In general, there are hardly any precise estimates of the proportion of falsified medicines in the EU. However, there is a number of indicators that provide an idea
of how relevant this issue has become for the public health sector and the pharmaceutical  industry. According to a WHO (World Health Organization) estimate,  1 in 10 medicines in low and middle-income countries are falsified. Although the overall situation in the EU is much better.

The implications of the new safety net for pharmaceutical importers

The pharmaceuticals authentication system is accompanied by an end-to-end verification of prescribed medicines sold in the EU.
For pharmaceutical parallel traders in the EU, this system creates specific requirements. Due to this authentication system,
European parallel traders will find themselves in a dual role in the future. In recent years, large parts of the medical import sector
have been preparing for this dual role. On the one hand, importers have to control the drug packages that they import from within
the EU and deactivate the distinguishing identification feature. On the other hand, importers themselves are supposed to equip re-labelled medical packages with an individual identifier. The data must then be uploaded to the EU hub connecting all national verification systems.

Future outlook of the public health industry

Most public health stakeholders are confident about the completed falsified medicines directive and the implementation of the specific measures that go along with it. Despite potential difficulties in the course of the initial phase, it is expected that the new system will soon prove itself to be effective. The majority of the public health sector agrees that the tremendous efforts and the large investments made are worthwhile in terms of expected results. The European Association of Euro Pharmaceutical Companies that represents the interests of pharmaceutical importers in the EU welcomed the conclusion of the directive and notes that patient safety has become the current priority topic of the entire public health sector.

Medical Shortage in hospitals has increased significantly

Last year, The European Association of Hospital Pharmacists (EAHP) conducted a study on bottlenecks in medicines in European hospitals. The results show that  medical shortages have worsened compared to the previous study conducted in 2014. For many health experts, the outcome of the study substantiates that medical shortages are a key issue for the European healthcare sector.

In particular, hospital pharmacists are concerned

The proportion of hospital pharmacists who indicate a deficiency as a problem in terms of optimal patient care has increased considerably. European hospital pharmacists emphasized the need for timely and accurate information shortages of medicines. Against the background of this result, the European Association of Hospital Pharmacists calls for comprehensive communication strategy on shortages. Targeting Member States will ensure that all supply chain actors receive adequate information on the medical shortages in their countries. In this regard, the EAHP stresses the need for all supply chain actors, the European Commission and national governments to improve the flow of information.

The problem relates to a variety of different active agents

Antimicrobials were the most commonly reported drug with bottlenecks at 77%. Problems have also been reported frequently with preventive medicines, vaccines (43%) and cancer medicines (39%). The combination medication Piperacillin/tazobactam, is the active ingredient most commonly associated with medical shortages. The shortage of this active ingredient was reported in 272 cases and in 18 different countries.

Understanding the causes of the issue
While 67% of the respondents reported their country has a system for reporting shortages in place, only 56 of those evaluated it to be effective. In addition to the ineffective information systems, however, it must be noted that the problems are quite different from country to country. Many respondents expressed their opinion, that manufacturers should be legally obliged to maintain stock levels and ensure sufficient supply of medicines, as it is the case in France. Other comments of feedback suggest severe problems when importing medicines from other countries, and the differences in price of the same medicine across Europe. The evaluation of the survey concludes that a deeper and more holistic analysis is needed as shortages are managed rather reactively instead of acting proactively. EMA has also addressed the topic of supply shortages in the area of medicinal products very seriously. Already in 2012 a reflection paper stipulates that the trend to focus manufacturing to a few manufacturing sites supplying at a global level gives rise to shortages. This is being corroborated by the fact that shortages do occur in countries with little or no parallel trade, such as Switzerland and the United States. EMA continues to state that industry’s risk management tends to be reactive rather than proactive. Here the agency is of the opinion that sustained pressure is needed to bring about a change so that industry takes a proactive approach to quality risk management – also with regard to supply chain integrity. Another study on the causes of medication shortages commissioned by EAEPC and performed by independent medical researcher Birgli in 2013 suggests that the pharmaceutical industry and medical supply chain are extremely complex and therefore exceptionally vulnerable for disruption, meaning small failures can have a big impact.

The four key-issues

• Product withdrawal: Pharmaceutical companies quickly withdraw pharmaceuticals from markets when they perceive that the current conditions are no longer
  sufficiently profitable.
• Production problems: With production facilities and processes having been streamlines over recent years, production has been concentrated on a smaller
  number of facilities making them more vulnerable for disruption; additionally a substantial mamount of quality related recalls over recent years has led to shortages.
• Quota-systems: Originally introduced by manufacturers to limit parallel distribution, the quota systems have now become a cause of shortages. Manufacturers
  supply quotas are often not flexible enough to quickly react to fluctuation in demand.
• Reimbursement problems: The overall financial situation in some high debt countries has led to delays in national health system reimbursements to pharmacies, resulting in pharmacies being unable to settle accounts with wholesalers and wholesalers mbeing unable to pay the producers. Additionally, in an attempt to reduce moverall costs many wholesalers and pharmacies have eliminated buffer stocks mleading to shortages if demand rises unexpectedly.

https://www.ema.europa.eu/en/documents/other/reflection-paper-medicinal-product-supply-shortages-causedmanufacturing/
good-manufacturing-practice-compliance-problems_en.pdf

Expert opinion

Safe medicines: A European success

Tobias Gotthard, Member of the Federal Bavarian State parliament Chairman of the Committee for
Federal and European Affairs

Medicines safety affects us all. The topic: Counterfeit medicine has been the focus of attention in recent years and has thus unsettled patients across the European Union.

Since 9 February, new rules have been introduced regarding the safety features of prescription medicines sold in the EU. The new rules set the capstone for the implementation of the 2011 directive on counterfeit medicines.

The new regulation serves patients across the EU – the main aim of the Directive is to ensure the quality and safety of medicines sold in the EU. This is a measure that MEPs have always called for: Every pharmacy and hospital in the EU should recognize counterfeit medicines immediately. The development of the security system will provide our citizens with efficient protection against counterfeit and dangerous medicines.

From now on, the pharmaceutical industry will have to apply a 2D barcode and an anti-tampering device to the packaging of prescription medicines. In addition, pharmacies (including online pharmacies) and hospitals must verify the authenticity of all these medicines prior to handing them over to the patient. Medicinal products manufactured before 9 February 2019 which have no safety features may continue to be sold until their expiration date. However, under the new end-to-end verification system, the relevant stakeholders (in particular, pharmacies and hospitals) must verify the authenticity of the drugs throughout the supply chain.

The wholesalers are also legally obliged to verify certain medicines. This included all medicines that are returned to them by pharmacies, as well as all medicines that they do not purchase directly from the manufacturer. The pharmaceutical parallel traders look with confidence towards the actual implementation. Their motto is clear: we are prepared and ready to go.

It took a long time for the European Union to tackle the problem of counterfeiting. With this new and decisive step, European patients can be increasingly sure that there are no counterfeits in the supply chain. Now, it is a matter of swift and effective implementation of the directive. Ultimately, this level of patient safety is another step towards strengthening Europe. Another important step.