Health Breaking News: Link 242

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News: Link 242

 

The creeping privatisation of healthcare: problematic EU policies and the corporate lobby push 

The new European Consensus on Development – EU and Member States sign joint strategy to eradicate poverty 

EU signs new consensus on development amid NGO outcry 

European Parliament Working Group on Innovation, Access to Medicines and Poverty-related Diseases 

Childers appointed Chair of Working Group on Access to Medicines & Poverty Related Diseases

Where Does WHO Get Its Economic Advice? 

WHO report: Ten years in public health 2007-2017 

‘The Unacceptable Inequity of Orphan Drugs Access in Europe: a Call for Urgent Policy Change’ by Katherine Eve Young and Mondher Toumi

Kaiser Health News: The Orphan Drug Machine 

Digital technologies to support End TB Strategy implementation 

‘Resistance to Isoniazide, Pyrazinamide and Fluoroquinolones in Patients with Tuberculosis’ by Matteo Zignol and Mario Raviglione 

WHO updates Essential Medicines List with new advice on use of antibiotics, and adds medicines for hepatitis C, HIV, tuberculosis and cancer 

(Statement) The Medicines Patent Pool on the Inclusion of its Licensed Antiretrovirals on the World Health Organization’s New Essential Medicines List 

MPP Report : PRIORITIZATION OF HIV AND HEPATITIS C MEDICINES FOR INLICENSING BY THE MEDICINES PATENT POOL 

Press note: Child-friendly formulation of WHO-recommended HIV treatment now approved by the CDSCO 

‘The Promise of PrEP for HIV Prevention’ by Marieke Bak 

Tobacco control: Developing an innovative and effective global strategy 

This Intervention Helps Underserved Women Access Needed Postpartum Care 

UNPO newsletter, May 2017 edition 

Videos of all the statements made by MMI/PHM during the last World Health Assembly

How will we know if the SDGs are having any impact? 

UN WFP, FAO chiefs unite to lobby for famine relief 

Burden faced by Africa’s small farmers masked by focus on migration and poverty 

Indigenous and environmental rights under attack in Brazil, UN rights experts warn 

‘The Venezuelan Powder Keg Floods in the Neighboring Countries’ by Pietro Dionisio  

Bloomberg delivers U.S. pledge to continue Paris climate goals to U.N. 

There is a silver lining to Trump’s Disasterous Decision to Pull out of the Paris Agreement 

With Ocean Ecosystems Facing “Total Annihilation,” Where Should Funders Be Focused?  

Our Shared Seas 

World Environment Day 

World Environment Day: a good time to reflect on unintended consequences 

Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients 

The Venezuelan Powder Keg Floods in the Neighboring Countries

As the country is running downhill day by day, Venezuelans are migrating searching salvation and healthcare necessities in neighboring countries, such as Brazil and Colombia. This diaspora  is causing rising tension in the region because of the inability of those countries to face the migrants’ requests due to their political fragility

By Pietro Dionisio

EU health project manager at Medea SRL, Florence, Italy

 Degree in Political Science, International Relations Cesare Alfieri School, University of Florence, Italy

  The Venezuelan Powder Keg Floods in the Neighboring Countries

 

While Venezuelans keep protesting against the Maduro’s Government, blamed of acting always more as a dictator, the country economy runs worse day by day. This is the third year of recession and last year its economy shrank 18%. The IMF’s prediction for inflation in Venezuela is pretty bad, but better than previous expectations: It’s expected to skyrocket 720% this year — somehow only half of the previous forecast. But if Venezuela stays on its current path, the IMF predicts inflation will rise over 2000% in 2018.

This has a deep impact on the health sector. Antibiotics are lacking and it is very difficult to get them, but that is not all. According to the most recent National Survey of Hospitals, 97% of services provided by hospitals are faulty, 75% of hospitals suffer from scarcity of medical supplies, and 63% reported problems with their water system.

Finally, Maduro’s administration decided to make public some health statistics, and what they reveal is dramatic. Venezuela’s infant mortality rose 30% last year (almost 11.000 children under the age of one died in 2016), maternal mortality shot up 65% and cases of malaria jumped 76%, according to government data, sharp increases reflecting how the country’s deep economic crisis has hammered at citizens’ health. Data showed also a jump in illnesses such as diphtheria and Zika.

Last March, Nicolas Maduro declared the necessity for the Venezuela’s public health system to radically change towards a universal, inclusive, humanistic, preventive and socialistic health system. Unfortunately, these words have no substance as the Country is collapsing on itself and is torn down by daily manifestations.

As Venezuela’s economic and social crisis has reached a boiling point in recent weeks, with enormous and increasingly violent protests and President Nicolás Maduro descending further into authoritarianism, it is not surprising that Venezuelans are trying to find salvation elsewhere. As such, those who can, are emigrating to Brazil asking for medicine and food. There is an unprecedented number of sick and hungry Venezuelans immigrating to a northern state of Brazil. More than 12,000 Venezuelans have entered via the border that Venezuela shares with the Brazilian state of Roraima and stayed in Brazil since 2014 and the volume is rising. 2016 alone saw 7,150 Venezuelans crossing the border.

The situation is not easy. As Brazil is reducing public funding for health, the Roraima State is trying to address the circumstances assisting both Brazilian and Venezuelans but with little success. The General Hospital of Roraima, which serves 80% of adults in the state, provided care to 1,815 Venezuelans in 2016, up more than three-fold from 2015. In February 2017, the hospital treated an average of 300 Venezuelan patients a month. The number of Venezuelan women seeking care at Roraima’s maternity hospital almost doubled in 2016, to 807. At the hospital in the border town of Pacaraima, about 80% of patients are Venezuelans, and Venezuelan women made more than half of prenatal care visits between January and August 2016.

In Roraima the system for processing asylum is not able to promptly process all the Venezuelans’ requests, both for the volume of application and the lack of requirements. In fact, many immigrants don’t fulfill the requirements for refugee status, which they are only granted if they can prove that they have suffered some kind of persecution or violation of human rights in their home country. To overcome the issue, the Government opted to grant temporary residence to Venezuelans and migrants from other bordering countries. In particular, the law aims at allowing Venezuelans who have requested asylum to stay in Brazil, obtain work permits and enroll their children in school.

But Brazil is not the only “land of salvation”. In fact, massive Venezuelan migration heads towards Colombia too. In January, 47,095 Venezuelans entered Colombia, more than double the number from January of last year. Some 21,000 of them crossed into Norte de Santander, the state of which Cúcuta is the capital. Here and at other points along the nearly 1,400-mile border, the situation is getting out of hand.

Furthermore, the most acute issue at the border is the rising number of Venezuelans making the journey for medical care and Colombia’s hospitals are starting to feel the pressure as they are not used to this high volume of Venezuelan patients.

The situation is getting worse day by day and is not affecting just Venezuela but also neighboring countries that are not ready to promptly assist the great volume of migrants crossing their borders. Colombia and Brazil’s health system are already extremely stressed by the internal care demand and therefore are unable to deal with an external emergency. This aggravates the healthcare emergency situation which was already dramatic before the increase of immigration. As long as Maduro does not decide to desert the authoritarian  turnaround that he is trying to enforce in his own country, it is likely that the humanitarian crisis in progress can only worsen, with negative implications for all North Latin America.

‘Orphan Drugs’ Business negli USA: un Monopolio Legalizzato

  ‘The Orphan Drug Act has been a great success because many people with diseases that affect very few people now have drugs available to them, but it's been in some ways turned on its head when it becomes the basis of manipulating the system for the drug company to make much more money than they would in an open, competitive market’

 Henry Waxman, former U.S. Representative for California’s congressional district and a champion of the Orphan Drug Act 

 by Daniele Dionisio

Membro, European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases

Responsabile del Progetto Policies for Equitable Access to Health – PEAH http://www.peah.it/

  ‘Orphan Drugs’ Business negli USA: un Monopolio Legalizzato

 

Nel 1983 l’amministrazione Reagan promulgò l’ Orphan Drug Act al fine di motivare le compagnie farmaceutiche allo sviluppo di medicine per patologie tanto rare da non poter contare su incentivi di mercato. La legge ottenne un successo senza precedenti grazie ai connessi incentivi, e dalla sua emanazione ad oggi almeno 450 ‘orphan drugs’ da parte di oltre 200 compagnie sono stati introdotti sul mercato.

In questo idilliaco scenario una recente indagine di Kaiser Health News (KHN), organo della Kaiser Family Foundation, ha tuttavia rilevato come l’industria farmaceutica americana manipoli disinvoltamente la legge per massimizzare i profitti senza limiti temporali ed applicare indisturbata prezzi astronomici su farmaci originariamente intesi per la cura di malattie singolarmente interessanti meno di 200.000 persone.

Indiscutibilmente, molti farmaci orfani non erano considerati tali all’esordio: più di 70 furono infatti originariamente approvati dalla Food and Drug Administration (FDA) per il mercato di massa e solo in seguito ottennero approvazione anche per le malattie rare. In ogni caso, i loro produttori hanno ricevuto milioni di dollari in incentivi governativi, oltre a diritti esclusivi per il trattamento di una o più malattie rare. Un monopolio di fatto che coinvolge presidi di successo commerciale mondiale, inclusi, tra gli altri, farmaci per l’ipercolesterolemia, per disturbi psichiatrici, cancerogeni come Herceptin® (trastuzumab) o antiartritici come Humira® (adalimumab).

Circa 80 farmaci orfani hanno guadagnato l’avallo di FDA per più di una malattia rara, e per ogni approvazione aggiuntiva nuovi incentivi sono stati erogati. Giusto ad esempio, Botox, inizialmente destinato alla cura degli spasmi muscolari oculari, oggi detiene tre approvazioni FDA come ‘orphan drug’, oltre all’accettazione nel mercato di massa per indicazioni includenti emicrania cronica e spianamento delle rughe del viso. Diversamente, Repatha® (evolocumab) approvato come farmaco orfano nel 2015 per l’ipercolesterolemia familiare omozigote (300 persone circa negli USA), fu lanciato in simultanea sul mercato di massa per il trattamento dell’LDL ipercolesterolemia nella popolazione generale.

E la proporzione dei nuovi farmaci approvati quali ‘orphan’ è in crescita (40% sulla totalità dei nuovi farmaci nel 2016 contro il 29% nel 2010). La tendenza non stupisce dal momento che l’approvazione per una malattia rara garantisce al produttore del farmaco incentivi economici e  7 anni di diritti esclusivi di mercato per quella malattia anche se il relativo brevetto sia nel frattempo scaduto. Intesa quale compensazione per lo sviluppo di un farmaco per ‘pochi’ pazienti, e perciò non profittevole, l’esclusività di fatto protegge la compagnia da qualsiasi competitore consentendole l’applicazione ‘ad libitum’ di prezzi di vendita elevati e variabili secondo la convenienza. Senza contare che prima della scadenza del settennato, le compagnie possono avanzare richiesta di una nuova indicazione ‘orphan’ per lo stesso farmaco. Ove accolta da FDA, la nuova indicazione garantisce altri 7 anni di esclusività specifica e incentivi finanziari (accesso a ‘grants’ federali e 50% sconto tassazione ricerca e sviluppo) per un monopolio virtualmente ‘eterno.’

Gli sviluppi correnti dell’Orphan Drug Act sono costati al governo federale quasi 2 miliardi di dollari nell’anno fiscale 2016. E in base al previsto ingresso di molti nuovi farmaci orfani, circa 50 miliardi di dollari saranno spesi in incentivi finanziari dal 2016 al 2025 secondo una stima del Dipartimento del Tesoro.

In sintesi, una rampante industria si è sviluppata grazie all’ Orphan Drug Act e alla consulenza o direzione strategica di ex funzionari governativi già in servizio presso FDA. Questi specialisti svolgono infatti un ruolo cruciale nell’aiutare le compagnie ad individuare appropriati target di malattie rare e superare l’iter processuale di FDA.

Molta creatività è richiesta allo scopo. Testare farmaci su minori con malattie più tipiche dell’età adulta (come la schizofrenia) ne è un esempio, così come lo sono proporre un farmaco per la cura di malattie infettive non comuni in USA, o apportare migliorie ad un ‘orphan drug’ già approvato (avvantaggiandosi dei test già condotti sulla formulazione originale), oppure suddividere la popolazione target in sottogruppi come nel caso di Humira®.  Approvato da FDA nel 2002 per il trattamento di milioni di persone con artrite reumatoide, Humira® ottenne nel 2008 la qualifica di farmaco orfano per la forma giovanile di artrite reumatoide (interessante circa 30.000-50.000 americani) e, in seguito per quattro più rare indicazioni incluse malattia di Chron e uveite.

FDA è stata sinora incapace di regolamentare gli evidenti squilibri innescati dall’Orphan Drug Act e di tenere le compagnie sotto controllo. A parziale ammenda, e dopo il clamore dell’indagine di KHN, l’Amministrazione si è recentemente impegnata nell’accertamento di eventuali inerenti abusi, lamentando nel contempo di mancare delle risorse necessarie per un’analisi esaustiva dell’intero database dei farmaci orfani.

 

PER APPROFONDIRE

Orphan Drug Act, Jan.4, 1983 https://history.nih.gov/research/downloads/PL97-414.pdf

List of FDA Orphan Drugs https://rarediseases.info.nih.gov/diseases/fda-orphan-drugs

Kaiser Health News: The Orphan Drug Machine http://khn.org/news/tag/orphan-drugs/

Drugs For Rare Diseases Have Become Uncommonly Rich Monopolies http://www.npr.org/sections/health-shots/2017/01/17/509506836/drugs-for-rare-diseases-have-become-uncommonly-rich-monopolies

‘Orphan Drug’ Loophole Needs Closing, Johns Hopkins Researchers Say http://www.hopkinsmedicine.org/news/media/releases/orphan_drug_loophole_needs_closing_johns_hopkins_researchers_say

U.S. Department of the Treasury: tax expenditures https://www.treasury.gov/resource-center/tax-policy/Documents/Tax-Expenditures-FY2017.pdf

A Look At How The Revolving Door Spins From FDA To Industry http://www.npr.org/sections/health-shots/2016/09/28/495694559/a-look-at-how-the-revolving-door-spins-from-fda-to-industry

Orphan Drug Regulations: An FDA Rule on 06/12/2013 https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations

High Prices For Orphan Drugs Strain Families And Insurers http://www.npr.org/sections/health-shots/2017/01/17/509507035/high-prices-for-orphan-drugs-strain-families-and-insurers

How Much Do Drugs For Rare Diseases Add To Health Care Spending? http://www.npr.org/sections/health-shots/2016/09/07/493000612/how-much-do-drugs-for-rare-diseases-add-to-health-care-spending

An FDA Program Incentivizing Rare Disease Drugs Will Be Investigated for Abuses http://fortune.com/2017/03/22/gao-fda-orphan-drug-program/

 

 

 

 

 

 

 

 

Resistance to Isoniazid, Pyrazinamide and Fluoroquinolones in Patients with Tuberculosis

Testing of resistance to isoniazid, pyrazinamide and fluoroquinolones is of paramount importance to guide treatment decisions and ensure that patients receive the best standard of care and have the highest chances to be cured. In this report the authors present an overview of the prevalence of resistance to isoniazid, pyrazinamide and fluoroquinolones and discuss the need of rapid diagnostics to detect resistance to these drugs

by Matteo Zignol

and Mario Raviglione

Global Tuberculosis Programme, World Health Organization

Resistance to Isoniazid, Pyrazinamide and Fluoroquinolones in Patients with Tuberculosis

 

Mycobacterium tuberculosis is today the top infectious killer with 1.8 million deaths caused by tuberculosis every year, including 390,000 among people with HIV infection. Every year, 10.4 million people are affected by tuberculosis. Furthermore, some 480,000 multidrug-resistant tuberculosis (MDR-TB) [1] cases emerge annually and an additional 100,000 cases of rifampicin-resistant tuberculosis, requiring the same treatment as MDR-TB, are estimated to arise in the same period of time. Drug-resistant tuberculosis represents a major threat to global health and may compromise the fight against tuberculosis in many countries.

Since 1994 the World Health Organization hosts a global project on surveillance of drug resistance in tuberculosis, which is the oldest and largest antimicrobial resistance surveillance project worldwide.

Very often when discussing of drug resistance in tuberculosis reference is made exclusively to MDR-TB and rifampicin-resistant tuberculosis, which are forms of tuberculosis requiring longer, more toxic and expensive treatment regimens with second-line drugs. However drug-resistance in tuberculosis is not exclusively MDR-TB or resistance to rifampicin.

Like rifampicin, isoniazid and pyrazinamide are the other two powerful drugs that are the pillars of the first-line regimen to treat tuberculosis. Fluoroquinolones (levofloxacin, moxifloxacin and gatifloxacin) represent the cornerstone of the second-line therapy to treat MDR-TB.

In this report we present an overview of the prevalence of resistance to isoniazid, pyrazinamide and fluoroquinolones and discuss the need of rapid diagnostics to detect resistance to these drugs.

Since current laboratory methods are sufficiently accurate for both, isoniazid resistance is usually investigated in parallel with rifampicin resistance: simultaneous resistance to both drugs defines a case of MDR-TB. Data from 155 countries for the period 1995−2015 collected either through continuous surveillance systems based on routine testing of all patients with tuberculosis or periodic surveys, which are discrete studies measuring drug resistance among a selected sample of patients who are representative of an entire population of tuberculosis patients, were used to estimate the prevalence of resistance to isoniazid without concurrent rifampicin resistance. Drug susceptibility testing results were available for 185,745 patients. The proportions of tuberculosis patients with strains that were resistant to isoniazid but susceptible to rifampicin were weighted by the number of new cases of tuberculosis that were notified in the country to generate regional and global averages.

Among all tuberculosis cases, the global average of isoniazid resistance without concurrent rifampicin resistance was 10.2% (95%CI: 8.4%–11.7%), ranging from 6.1% in the African region to 13.3% in the European region. With the expansion of the use of Xpert MTB/RIF testing (Cepheid, Sunnyvale, CA, USA) in many countries it is important to note that on average around one in 10 TB patients diagnosed to be sensitive to rifampicin will have isoniazid resistance that cannot be detected by the current Xpert MTB/RIF assay. These patients are likely to have poorer treatment outcomes and higher risk of acquiring rifampicin resistance during treatment compared to patients with fully susceptible tuberculosis, as shown in a recent systematic review of 3,744 patients with isoniazid-resistant tuberculosis (Gegia M et al. Lancet Infect Dis. 2017;17(2):223–234).

Pyrazinamide resistance is not routinely investigated as part of diagnostic and surveillance efforts in most settings because of the limitation of the currently available phenotypic test (MGIT 960) which is expensive, difficult to perform and poorly reproducible. For this reason, little information about the extent of resistance to pyrazinamide at the population level is available. Sequencing of the pncA gene of M. tuberculosis that expresses resistance to the drug is becoming an alternative method to investigate resistance to pyrazinamide. Data were gathered from surveys conducted in five countries (Azerbaijan, Bangladesh, Belarus, Pakistan, and South Africa) on a total of 4,972 patients. Levels of resistance varied substantially in the surveyed settings (3.0–42.1%) and resistance to pyrazinamide was always significantly associated to rifampicin resistance. Despite this finding, for a substantial proportion of patients with rifampicin-resistant tuberculosis (19–63%) pyrazinamide is still effective, confirming that this drug could still be used as part of the second-line regimen for the treatment of MDR-TB, as currently recommended by the World Health Organization.

Later generation fluoroquinolones, including levofloxacin and more importantly moxifloxacin and gatifloxacin (which are the newest molecules belonging to the 4th generation), are considered the most important drug class for the treatment of MDR-TB.  Fluoroquinolones are currently being investigated in clinical trials to assess the efficacy of short rifampicin-sparing regimens for the treatment of tuberculosis (e.g. the NC-005 trial of TB Alliance). The prevalence of resistance to fluoroquinolones is unknown in many countries due to the limited laboratory capacity to perform second-line drug susceptibility testing. Data were gathered from surveys conducted in five countries (Azerbaijan, Bangladesh, Belarus, Pakistan, and South Africa) on a total of 5,015 patients. Overall levels of resistance to fluoroquinolones among all tuberculosis patients ranged from 0.5 to 12.4% for levofloxacin, and from 0.9 to 14.6% for moxifloxacin. Among patients with rifampicin resistance the prevalence of resistance to fluoroquinolones was significantly higher, ranging from 8.4 to 26.8% for moxifloxacin. Cross resistance between levofloxacin and moxifloxacin (when tested at 0.5 μg/mL) was nearly complete. High levels of fluoroquinolones resistance were detected in Pakistan, which can be the expression of extensive and unregulated use of fluoroquinolones in that country.

Testing of resistance to isoniazid, pyrazinamide and fluoroquinolones is of paramount importance to guide treatment decisions and ensure that patients receive the best standard of care and have the highest chances to be cured.  Over the past few years progress has been made on the development of rapid molecular tests to detect drug resistance in tuberculosis, with Xpert MTB/RIF being the best example, given the limited technical requirements, relatively low cost and rapidity in producing results.  However, at the moment, easy-to-perform, automated and rapid molecular tests to detect resistance are currently available only for rifampicin. The understanding of the genetic basis of drug resistance and of the correlation between genotypic and phenotypic testing results is rapidly improving. This should lead to the development of a larger range of molecular diagnostic tools capable to effectively detect resistance to several drugs, in particular to isoniazid, pyrazinamide and fluoroquinolones, in addition to rifampicin. Candidates exist and are undergoing testing in trials, although it may take a few more years before they become widely available. These rapid drug susceptibility tests are today a must as medical practice keeps evolving towards more precision and personalization. Without new rapid tests a large number of patients will continue receiving therapies which are often inadequate to combat the bacilli they harbor, with a higher risk of treatment failure, creation of additional resistance and continued transmission of the disease.

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[1] MDR-TB is defined as a form of tuberculosis that is resistant to at least isoniazid and rifampicin

The Unacceptable Inequity of Orphan Drugs Access in Europe: a Call for Urgent Policy Change

The current EU policy has a low ability to align access to orphan drugs across different Member States, leaving high inequity, especially between richer and poorer countries...
The variation stems from the fact that although the marketing authorisation of drugs is at the European level, pricing and reimbursement decisions, and therefore patient access, are on a national level...
Perhaps, to assure equal access to orphan drugs for all rare diseases, an EU-wide procurement should be considered...
The EU can procure orphan drugs centrally and charge the MS based on their affordability while setting a fixed pan-European list price. Ultimately this will result in a differential pricing scheme

By Katherine Eve Young

MD, MSc, MPH Manager Pricing & Market Access Creativ-Ceutical

and Mondher Toumi

Professor of Public Health University of Aix-Marseille, and CEO at Creativ-Ceutical

The Unacceptable Inequity of Orphan Drugs Access in Europe: a Call for Urgent Policy Change

 

The treaty on European Union states that ‘the Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities. These values are common to the Member States (MS) in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail… A high level of human health protection shall be ensured in the definition and implementation of all EU policies and activities, thus solidifying the EU’s duty to promote good health.’

On one hand lies the EU model. On the other hand, data shows that the battle against wealth and health inequality in Europe is still an ongoing feat. Eurostat data shows that Europeans from Central and Eastern Europe die younger than their Western counterparts. In their already shorter lives, around 20 years are not lived in good health. Thus, while men in Denmark can expect to live 90% of their lives in good health, men in Estonia only live 71% of their already shorter lives as healthy individuals.

The determinants of health are multifactorial and as such, the causes of health inequalities are complex. Health is determined by social and economic factors such as education, environment, lifestyle determinants, working conditions, and social protection.[1] Undoubtedly, health is also determined by healthcare systems, such as the presence of universal coverage and the price and affordability of medicines.  The European Pharma Forum in 2008 has extensively discussed the price of drugs as a cause of health inequity in Europe.

Orphan drugs, medicines intended for the diagnosis, prevention or treatment of rare diseases are central to discussions on high drug prices and low health equity. Rare diseases are usually severe conditions with no or limited choice of therapeutic options, and thus present with a high level of unmet need. Regardless of the unmet need, orphan drugs are notorious to have higher prices than non-orphan drugs rendering them inaccessible to some patients across Member States. The variation stems from the fact that although the marketing authorisation of drugs is at the European level, pricing and reimbursement decisions, and therefore patient access, are on a national level.  The European Commission, Ministries of Health of Member States, and relevant European organisations have voiced their concerns regarding health inequity and non-accessibility of orphan drugs to vulnerable population.[2],[3] As a possible solution to address these inequity concerns, several discussions on differential pricing have joined the narrative.[4],[5],[6],[7],[8] Differential pricing (DPR) ‘is based on the economic concept of price discrimination whereby prices of the same products are variedly set for different consumer groups in different geographical or socio-economic segments based on the income or purchasing power of those buyers.’[9]

Amidst the discussion on how differential pricing can offer solutions to the ongoing issue of inequitable access to drugs, it has been found too challenging to implement. The differentiation and grouping of countries based on income levels is the first hurdle. Second, due to the free movement of people and goods in Europe, parallel trade is unavoidable and thus different prices between states will cause the importation of drugs from low-priced countries to high-priced countries. This may lead to drug shortages in low-priced countries. As such, similarity in absolute prices among neighbouring countries is continuously utilised in Europe. Thirdly, the harmonisation of value assessment and the agreement on the formula for differential price calculations across member states is a high wall to climb which will not only need relevant policy change, but also significant political will and the assured cooperation of all Member States, the industry and the public healthcare systems. DPR has been effectively used in vaccines, contraceptives, and anti-retroviral treatments globally. The European Commission has considered procuring orphan drugs at the EU level but this has been faced with resistance from Member States and was not pursued.

Publications and insight on EU orphan drug access are available but these are not recent. Three publications related to the comparison of EU prices in rare diseases date from 2004–2011, when fewer orphan drugs were launched and thus are relatively less comprehensive in terms of the number of orphan drugs analysed. In more recent years, the inequitable access to orphan drugs has significantly increased as the prices have soared and the affordability in lower GDP countries has plunged.  Various studies in the literature have investigated the relevant issue of inequitable access of drugs between high GDP and low GDP countries in Europe. No study was found assessing the relative prices of orphan drugs. To appreciate this issue better, we did a study where we assessed the affordability of orphan drugs in 12 European countries.[10] We compared the annual treatment cost per patient adjusted by nominal GDP per capita, GDP in PPP per capita, % GDP contributed by the government, government budget per inhabitant, % GDP spent on healthcare, % GDP spent on pharmaceuticals, and average annual salary of similarly available orphan drugs in high and low GDP countries in Europe: Bulgaria, France, Germany, Greece, Hungary, Italy, Norway, Poland, Romania, Spain, Sweden, UK. We have uncovered that the median annual costs of orphan drugs in all countries varied minimally. However, when the annual costs were adjusted using GDP per capita, the lower GDP countries showed three to six times higher relative costs (Figure 1).

The same pattern was evident when costs were adjusted using the other economic parameters. When the costs were adjusted using average annual salary per inhabitant, the lower GDP countries showed higher costs than high-GDP countries by a factor of around 3 to 9. This means that an average individual in lower GDP countries will have to work nine times more (Bulgaria) than their western counterparts in order to afford the same drug.  To note, drug spending in low GDP countries is mostly out of the pocket which exacerbates affordability issues. GDP share contributed by the government and government budget per inhabitant show the lower per capita spending by the government in low-GDP countries resulting in increased relative costs per patient, lower ability to pay, and thus in limited access to orphan drugs for rare diseases which lack alternative treatment.

Our results validate that the current EU policy has a low ability to align access to orphan drugs across different Member States, leaving high inequity, especially between richer and poorer countries. The European model upholds the principle of equity in patient access to treatment and solidarity where the richer population subsidizes marginalized or economically challenged populations. However, these principles have not been fully achieved yet and the current inability to cater to vulnerable populations is unacceptable in more ways than one. Perhaps, to assure equal access to orphan drugs for all rare diseases, an EU-wide procurement should be considered.

It is noteworthy to observe that in the agriculture sector we have been able to put in place the EU – Common agriculture policy (EU-CAP), a complex and expensive compensation system that leads to the differential pricing of agriculture goods but which consequently benefits a large and quite rich EU country like France. The EU-CAP guarantees a stable fix price of agriculture products throughout the EU which avoids visibility and speculation on producers. As the market price of the products is often below the guarantee price, the EU pays the producers the deficit as a form of compensation. France captures 60% of this money. This means that instead of investing in economic changes and future revenue, we are investing in covering the deficit of agriculture producers who are producing at a cost that is significantly above the market price. Of note, the EU-CAP represents around 50% of the EU budget.

Why is this framework considered unfeasible for orphan drugs? The EU has considered multiple options on how to resolve the unacceptable inequity, from differential pricing with compensation, to EU global procurement for all MS and the distribution at a differential price even though the listed price is uniquely fixed, a similar process as the EU-CAP. These were never implemented. We firmly believe that there is no reason why we could not implement a similar process for orphan drugs. The EU can procure orphan drugs centrally and charge the MS based on their affordability while setting a fixed pan-European list price. Ultimately this will result in a differential pricing scheme while avoiding parallel trade at the same time.

Rare disease remains a neglected area with little empathy from decision makers and manufacturers leading to major inequity in access. New policies are needed. Equally important, alignment among Member states is needed to attain the principles set in the EU treaty. In this Union, we all look forward to the day when we will achieve the valued respect for human dignity, democracy, equality, justice, solidarity – and consequently the well-being of all people.

 

References

[1] WHO. Commission on Social Determinants of Health, 2005-2008. http://www.who.int/social_determinants/thecommission/en/

[2] European Commission. Solidarity in Health: Reducing Health Inequalities in the EU http://ec.europa.eu/health/social_determinants/policy/commission_communication_en

[3] Kenny, M. Crazy” European Orphan Drug Pricing System Has To End. SCRIP Pharma Intelligence Pink Sheet. 2016 https://pink.pharmamedtechbi.com/PS118869/Crazy-European-Orphan-Drug-Pricing-System-Has-To-End

[4] De Cock Jo. Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability. ISPOR 19th Annual European Congress Plenary Session. October 2016. Vienna, Austria. https://www.ispor.org/Event/ReleasedPresentations/2016Vienna

[5] Vogler S. Differential Pricing of Medicines in Europe. ISPOR 19th Annual European Congress Plenary Session. October 2016. Vienna, Austria. https://www.ispor.org/Event/ReleasedPresentations/2016Vienna

[6] Kanavos P. Differential Pricing of Medicines in Europe: Implications for Access, Innovation, and Affordability. ISPOR 19th Annual European Congress Plenary Session. October 2016. Vienna, Austria. https://www.ispor.org/Event/ReleasedPresentations/2016Vienna

[7] Towse A, Pistollato M, Mestre-Ferrandiz J, Khan Z, Kaura S, Garrison L (2015) European Union Pharmaceutical Markets: A Case for Differential Pricing?, International Journal of the Economics of Business, 22:2, 263-275

[8] Remuzat C, Tavella F, Toumi M. Differential pricing for pharmaceuticals: overview of a widely debated pricing concept and key challenges. ISPOR 18th Annual European Congress. Milan, Italy. November, 2015. https://www.ispor.org/research_pdfs/51/pdffiles/PHP71.pdf

[9] Yadav, P. Differential Pricing for Pharmaceuticals. Study conducted for the U.K. Department for International Development. 2010

[10] Young K, Soussi I, Toumi M. The Perversion of External Reference Pricing (ERP): A Comparison of Orphan Drug Affordability in 12 European Countries. A Call for Policy Change. Journal of Market Access & Health Policy (in press)

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Projected savings through public health voluntary licences of HIV drugs negotiated by the Medicines Patent Pool (MPP) 

 

The Promise of PrEP for HIV Prevention

A large international study among gay men and transgender women,the so-called iPrEx trial, suggested that pre-exposure prophylaxys (PrEP) by a tenofovir/emtricitabine combination can reduce the risk of HIV infection by at least 92% when the pills are taken consistently. Other trials subsequently confirmed PrEP effectiveness. 

PrEP is not intended as a stand-alone intervention, but rather as part of a multi-faceted strategy involving the use of condoms as well as regular follow-ups including for HIV and other sexually transmitted diseases testing

By Marieke Bak

Research Intern at AFEW International

The Promise of PrEP for HIV Prevention

 

Despite significant progress in the past decades, the global HIV/AIDS epidemic remains a major public health issue. In 2015, an estimated 36.7 million people worldwide were living with HIV, representing a global prevalence of 0.8%. Declines in new HIV infections have slowed in recent years, and in some regions the incidence of HIV continues to grow. One of the most rapidly accelerating epidemics is currently taking place in Eastern Europe and Central Asia, where new HIV infections rose by 57% between 2010 and 2015. Thus, the fight against HIV continues, and has become intensified since the United Nations committed to ending the epidemic by the year 2030.

Recognising that universal access to testing and treatment alone will not stop the epidemic, UNAIDS has been calling for a “much stronger primary prevention response” and recommends that 25% of national HIV budgets is spent on prevention. Moreover, countries are urged to use a combination approach to HIV prevention, consisting of behavioural, biomedical and structural interventions.

However, current biomedical and behavioural interventions are of limited effectiveness in many settings. Behavioural strategies such as celibacy and mutual monogamy are not reliable or realistic for many people worldwide. In addition, negotiating condom use can be difficult or impossible in some settings, or the effect of condoms on sexual pleasure may lead to non-use. Moreover, it was found that self-reported consistent condom use only reduces the risk of HIV acquisition by 63% to 72% among men who have sex with men (MSM), one of the key populations at risk for HIV infection, and by 80% among heterosexual men and women. Treatment as prevention (TasP) also has limitations, since it is dependent upon partners’ medication adherence to ensure suppressed viral load. Moreover, viral suppression rates are not high enough to prevent new infections solely through TasP.

Considering these limitations, there has been a need for additional prevention strategies that are effective and do not place the risk of HIV infection in other people’s hands. Provision of pre-exposure prophylaxis (PrEP) may be such a strategy. PrEP is a daily pill consisting of a combination of tenofovir/emtricitabine, two anti-retroviral drugs. It is branded by Gilead Sciences as Truvada which was approved for prevention in 2012 by the Food and Drug Administration (FDA) in the United States. In contrast to PEP, or post-exposure prophylaxis, PrEP is taken before exposure to HIV to prevent any possible transmission. It works by blocking an enzyme called HIV reverse transcriptase, thereby preventing HIV from establishing itself in the body.

A large international study among gay men and transgender women, the so-called iPrEx trial, suggested that PrEP can reduce the risk of HIV infection by at least 92% when the pills are taken consistently. Other trials subsequently confirmed PrEP effectiveness.  However, because it is not 100% effective and because it does not protect from other sexually transmitted diseases (STDs), PrEP is not intended as a stand-alone intervention, but rather as part of a multi-faceted strategy involving the use of condoms as well as regular follow-ups. These visits should take place every three months and consist of HIV testing, testing for other STDs, assessment of side effects, and counselling on medication adherence and risk reduction.

In addition to the promising effectiveness data, one of the main advantages of PrEP is that it puts HIV prevention directly under the control of the at-risk individual. Because PrEP separates the act of prevention from the sexual encounter, it can be used without sexual partners knowing. This makes PrEP a “gender-sensitive” strategy: it does not require consent from a male partner, which is a major advantage in settings where women are disempowered to discuss condom use.

With PrEP, the individuals become empowered to take control of their own health, and it has been suggested that PreP might “transform HIV infection just like hormonal contraception transformed family planning”. Also, it enables those who are in serodiscordant relationships to have sex without condom, and is a welcome new option for couples who wish to conceive. Lastly, a well-functioning PrEP programme with regular follow-ups might have the added benefit of strengthening healthcare systems and HIV services.

There are some side effects associated with Truvada for PrEP, although these are generally minor symptoms such as nausea and headaches that resolve within a few weeks. In rare cases, people may experience small changes in kidney function or a decrease in bone mineral density. An updated version of Truvada known as Descovy, that is thought to have fewer side effects, is currently being investigated in the so-called “Discover study”.

Because PrEP does not prevent transmission of other sexually transmitted diseases, there have been fears that PrEP might be used as a “party drug” and lead to increasing rates of other STDs. In fact, in the iPrEx study as well as in a meta-analysis by the World Health Organisation (WHO), it was shown that PrEP does not lead to an increase in the number of STDs and has no effect on condom use. On the contrary, a recent study found that PrEP use can actually reduce the incidence of STDs among men who have sex with men, because it involves routine screening and treatment of other STDs.

The World Health Organization now recommends that PrEP should be offered as a choice to key populations affected by HIV as well as to anyone else at substantial risk of HIV infection. However, Truvada is currently approved for use as PrEP only in a handful of countries, while a number of countries are conducting pilots, and access is expanding slowly across the world. Global availability remains limited at 2% of the target set by UNAIDS to get three million people on PrEP by 2020.

At the moment, Truvada for PrEP has been approved in the United States, Canada, Australia, Peru, South Africa, Kenya, Zimbabwe, Israel, and the European Union. Approval is pending in Brazil and Thailand. In the European Union, PrEP has been approved by the European Medicines Agency (EMA) although the implementation of PrEP programmes is the responsibility of each member state separately. To date, only France and Norway have made PrEP available as part of their healthcare system. Scotland recently announced that it will do the same.

The hesitation to fund PrEP often stems not only from seemingly unfounded worries for risk compensation, but also from the high cost of PrEP. Even in low- and middle income countries where generic versions of Truvada are generally available, drug prices still present a barrier to the accessibility of PrEP and may lead to developing countries having to make trade-offs between prevention and treatment. Indeed, PrEP is more expensive than other HIV prevention methods, but it can be a cost-effective tool in some settings, especially when delivered to key population. According to the WHO, offering PrEP can be cost-effective when the HIV incidence is greater than 3 per 100 persons. A study published in the Lancet reported that by preventing the costs of lifetime HIV treatment, PrEP may eventually lead to healthcare savings, especially when the drug patents expire and the cost drops.

Since it is widely recognised that treatment alone is not sufficient to eradicate HIV, and given the high effectiveness of PrEP, countries should make an effort to provide access to PrEP among those at risk of HIV infection. While keeping in mind that PrEP is part of a combination prevention approach, scaling up of PrEP programmes will be a significant step towards ending the global HIV/AIDS epidemic.

Health Breaking News: Link 240

Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

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Health Breaking News Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

Health Breaking News: Link 239

 

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SOS A LA SITUATION HUMANITAIRE EN REPUBLIQUE DEMOCRATIQUE DU CONGO

La République démocratique du Congo continue à être confrontée à une crise humanitaire de très grande ampleur, et cela depuis plus de deux décennies, bien que la grande majorité du territoire nationale demeure stable, mais les provinces du Sud-Kivu, du Nord-Kivu, du Tanganyika et du Kasaï central sont les théâtres des tueries, massacres et violations répétitives des droits de l’homme à l’heure actuelle

By Alphonse Kitoga

Secretary General, Grands-Lacs en Action pour la Paix et le Développement Durable -The Great-Lakes in Action for Peace and the sustainable Development

GLAPD_ Africa, asbl

SOS A LA SITUATION HUMANITAIRE DANS LES PROVINCES DU TANGANYIKA, DU KASAЇ-KANANGA, DU NORD-KIVU et DU SUD-KIVU EN REPUBLIQUE DEMOCRATIQUE DU CONGO/DRC

 

 

I. INTRODUCTION

Avec environ 65 millions d’habitant, la R.D.Congo a une superficie de 2 345 410 KM2 (4 fois la France et 80 fois la Belgique) et avec 26 provinces et, Kinshasa sa capitale compte environ 10 millions d’habitants (plus que les populations du Congo-Brazzaville, du Gabon et de la République Centrafricaine réunies).

En effet, dans plusieurs provinces de la RDC les milices ne font que se multiplier (on arme et on manipule les jeunes/les adolescents(es) qui ne peuvent plus étudier car leurs parents se sont appauvrit et n’ont pas de travail. Avec l’arrivée de près de 15.000 réfugiés Burundais dans la plaine de la Ruzizi au Sud-Kivu en raison des tensions ethniques qui se vit dans leur pays le Burundi qui sème panique et désolation dans le chef de la population de cette région martyrisée. Signalons également que les provinces du Nord et du Sud-Kivu compte plus de 1.000000 des déplacés et plus de 200 000 réfugiés Rwandais qui surplombe toutes les deux provinces!

II. RESUME EXECUTIF ET NARRATIF

La République démocratique du Congo continue à être confrontée à une crise humanitaire de très grande ampleur, et cela depuis plus de deux décennies, bien que la grande majorité du territoire nationale demeure stable, mais les provinces du Sud-Kivu, du Nord-Kivu, du Tanganyika et du Kasaï central sont les théâtres des tueries, massacres et violations répétitives des droits de l’homme à l’heure actuelle.

Cependant que, cette crise est principalement la conséquence de conflits armés, des conflits intercommunautaire, coutumiers et de violences armées qui perdurent dans l’Est, le nord-Est et dans le centre du pays. Ces conflits sont causés en particulier par des luttes pour le contrôle des ressources naturelles et l’accès à la terre, par des tensions ethniques et par l’activisme de groupes armés congolais et étrangers (FDRL, LRA, groupes Maï-Maï, AFD/NALU, le M23, les Pygmées/Batwa contre les Bantous-Baluba dans le Tanganyika et les miliciens du Chef coutumier Kamwina N’sapu dans le Kasaï central/Kananga avec les forces de l’ordre/l’armée régulière), dans un contexte caractérisé par une pauvreté exacerbée et une trop faible présence des institutions de l’Etat. Les exactions graves commises par les parties belligérantes sur les populations civiles, tels que viols, meurtres, recrutements forcés des enfants/adolescents dans les forces et groupes armés et pillages, demeurent la cause principale des déplacements de population et de la crise humanitaire liée à ces déplacements. Des centaines de milliers de civils ont fui ces exactions en 2011 à ces jours!

L’année 2016-2017 a également été marquée par des violences intercommunautaires entre les Pygmées/Batwa contre les Bantous-Baluba qui ont éclaté en la province de Tanganyika en octobre 2016, provoquant la fuite de près de 470.000 personnes déplacées et dont le site de Kalunga à Kalemie compte à lui seul 17.500 déplacés et nombreux dans eux sont des femmes, des enfants et des adolescents. A cela s’ajoutent près de 650 000 déplacés internes prenant fuite du conflit intercommunautaire et coutumier orchestré par les miliciens du Chef coutumier Kamwina N’sapu dans le Kasaï central/Kananga avec les forces de l’ordre/l’armée régulière.

Les besoins humanitaires demeurent également très importants dans les autres provinces où l’on a relevé des taux élevés de malnutrition aigüe et sévère, d’insécurité alimentaire, et de mortalité maternelle, infantile et néo-natale. Les causes en sont avant tout le faible niveau de développement, l’enclavement et la précarité des infrastructures, les épidémies et les catastrophes naturelles pour ne citer que ceux-là.

Bien que la situation se soit stabilisée depuis un certain temps, très peu de mouvements de retour ont été observés à ce jour. Les acteurs humanitaires ont répondu aux besoins les plus urgents et ont porté assistance à des millions de personnes. Mais cela reste très peu insuffisant et visible pour ceux qui en n’ont besoin le plus. L’action humanitaire a été confrontée à des défis importants, en particulier concernant l’accès aux populations vulnérables dans des zones très enclavées. Dans les régions en proie à la violence, les conditions de sécurité précaires affectant les partenaires humanitaires ont réduit les opérations d’assistance. Le bas niveau de financement a constitué un frein supplémentaire.

Pour pallier à cela, les axes suivants doivent être pris en ligne de compte:
1. Renforcer la protection de la population civile vulnérable (surtout les femmes, enfants et les adolescents) dans les zones d’intervention humanitaires ;
2. Réduire la morbidité et la mortalité maternelle, infantile et néonatale au sein des populations cible;
3. Améliorer les conditions de vie des personnes déplacées, retournées, rapatriées, réfugiées, et de leurs communautés d’accueils affectées, et
4. Restaurer les moyens de subsistance des communautés affectées, sur la base de critères de vulnérabilité.

Du fait de la persistance de violations graves des droits de l’homme et du droit international humanitaire, en particulier dans les zones affectées par des conflits armés, intercommunautaires et la violence armée, la protection des civils doit être au coeur de la communauté humanitaire dans toutes ses interventions.

III. CONTEXTE HUMANITAIRE PAR SECTEUR EN RDC

Bien que la majorité du territoire national demeure peu stable, la RDC continue à être marquée par une crise humanitaire de très grande ampleur. Celle-ci est la conséquence des conflits armés et violences armées qui perdurent.

Les populations vivent dans un état de l’insécurité permanente, chaque jour des braquages des véhicules, les pillages, assassinats, tueries,…
La situation sécuritaire sur toute l’étendue du pays continue aussi à ce détérioré du jour au lendemain. Presque toutes les parties du pays sont confrontées à des problèmes récurrents d’insécurité et de l’activité des groupes armés, milices du Chef coutumier Kamwina N’sapu au Kasaï centrale, les conflits intercommunautaires entre les Bantous et les Pygmées, dans le Tanganyika, l’ancien Kivu avec sa multitude des groupes armés avec le retour du phénomène M23 et conflits intercommunautaires au Maniema. La crise humanitaire dans l’ensemble du pays a également pour cause la pauvreté, le manque de développement d’infrastructures, les épidémies et les catastrophes naturelles comme dit précédemment.

Secteur de la santé: Besoins identifiés:

Toutes les provinces de la RDC continuent d’être exposées, à des degrés divers, aux endémies ou épidémies, aux mouvements de population et aux catastrophes naturelles. Plusieurs épisodes d’épidémies ont été rapportés dans plusieurs zones de santé. Il s’agit essentiellement du paludisme (plus de 20 millions de cas, la RDC étant l’un des pays les plus touchés par le paludisme en Afrique), du choléra (12 161 cas), de la méningite (218 cas), de la fièvre jaune (5 cas confirmés) et 15 cas suspects de fièvres hémorragiques virales non confirmés.

La mortalité maternelle, néo-natale et infantile continue d’être une préoccupation dans presque toutes les provinces, soit un taux de 549 décès maternels pour 100 000 naissances vivantes et un taux de mortalité infantile des moins de 5 ans dépassant 2/10 000/ jour dans 22% des zones de santé.

Plan de réponse du Secteur:
Objectif général: contribuer à la réduction de la morbidité et de la mortalité liées aux conséquences Sanitaires dans les situations de crise.

Objectifs spécifiques:
1) Renforcer les actions en faveur de la réduction de 10%; de la mortalité maternelle, néo-natale et de la mortalité infantile des moins de 5 ans;

2) Activer les mécanismes de riposte en moins de 15 jours dans au moins 80% des épidémies constatées / confirmées;

3) Renforcer les capacités techniques et institutionnelles dans la prise en charge des cas / personnes en situation d’urgence sur tout chez les femmes, les enfants, les adolescents et les vieillards.

Secteur de la protection: Besoins identifiés:

Plusieurs facteurs mènent à l’heure actuelle à une aggravation de la vulnérabilité des populations. A une vulnérabilité structurelle très forte s’ajoutent une crise conjoncturelle due à la présence des groupes armés et autres acteurs non étatiques, les vaines tentatives de l’armée congolaise (FARDC) et de la MONUSCO de les déloger et les violations du droit international humanitaire (DIH) et des droits de l’homme (DDH) perpétrées par les agents de l’Etat eux-mêmes. Ces violations entraînent une aggravation de l’instabilité, une insécurité localisée permanente, des déplacements forcés et des séparations familiales dans les zones touchées.

La prévention des violences sexuelles et la prise en charge multisectorielle de toutes les victimes restent un besoin important dans le pays tout comme le sont la protection et la prise en charge des femmes et enfants/adolescents victimes de violations de leurs droits.

Plan de réponse du Secteur:
Objectif général: Accroître la protection de la population civile affectée par l’insécurité, les conflits, le déplacement et les violations sévères des droits de l’homme.

Objectifs spécifiques:
1) Renforcer et harmoniser le système de collecte et d’analyse de données sur la situation des populations civiles et leurs besoins de protection dans le but de surveiller les risques et d’améliorer l’identification des priorités des activités de protection.
2) Améliorer l’accès à l’assistance, la justice, la compensation, la réhabilitation et la restitution des victimes.

Secteur de l’éducation: Besoins identifiés:

Les chiffres les plus récents montrent qu’en moyenne 46% des filles achèvent l’école primaire contre 66,5% des garçons, et seulement 28,8% des filles s’inscrivent au secondaire contre 51,2% des garçons; 1 homme adulte sur 5 et près d’1 femme sur 2 sont analphabètes au Congo. Les chiffres pour l’Est du Congo ainsi que pour la province du Kasaï sont en dessous de la moyenne. La complexité actuelle de la situation nécessite une adaptation de l’assistance humanitaire et la mise en place de mécanismes de ciblage des besoins plus pertinents, basés sur l’analyse des vulnérabilités des familles bénéficiaires.

Plan de réponse du Secteur:
Objectif général: contribuer à l’accès à des activités éducatives de qualité dans un environnement protecteur et adapté en faveur des filles et des garçons, adolescentes et adolescents de 3 à 18 ans, en situation de handicap ou non, victimes de catastrophes naturelles ou causées par l’homme, de conflits ou vivant dans des conditions de forte vulnérabilité.

Objectif spécifique 1: l’accès de 240 000 filles et garçons (>50% filles) à une éducation de base et de qualité (formelle et non-formelle) est assuré;

Objectif spécifique 2: au moins 19 00 espaces d’apprentissage sont adaptés, aménagés et protecteurs;

Objectif spécifique 3: l’inégalité d’accès à l’apprentissage est réduite grâce à la mise oeuvre pour la prise en compte du genre et des enfants en situation de handicap;

Les activités suivantes sont possibles pour réaliser ces objectifs:

1. Appui à l’identification des enfants, des jeunes et des adolescents (f/g) de 3-18 ans en vue de leur inscription dans les écoles existantes ou dans les espaces d’apprentissage à créer;
2. Plaidoyer et sensibilisation des responsables de l’Enseignement primaire, secondaire et professionnel (EPSP) pour le recrutement des enseignants en quantité et de qualité suffisantes et leur déploiement rapide dans les régions d’intervention; tout en encourageant une égale représentation des femmes et des hommes et la non-discrimination à l’égard des enfants en situation de handicap;
3. Réhabilitation et aménagement d’espaces d’apprentissage temporaires avec l’accès aux blocs de latrines pour tous et distinct entre filles et garçons, la mise en place de points d’eau, en utilisant des matériaux locaux ou temporaires afin de réduire le coût de l’aménagement.
4. Appui aux activités d’allégement de la charge financière des parents (activités génératrices de revenus, AGR);
5. Organisation de cantines scolaires avec vivres;
6. Fourniture de kits d’apprentissage aux enfants;

Secteur de la sécurité alimentaire: Besoins identifiés:

La baisse de la production agricole, le mauvais état des routes de desserte agricole et la dégradation de l’état nutritionnel de groupes ciblés, l’abandon des moyens de subsistance, l’insécurité, le manque d’accès à l’eau de qualité et une alimentation saine et équilibrée. Les voies de communication sont délabrées empêchant les échanges et l’accès au marché des populations au pouvoir d’achat faible!

Plan de réponse du Secteur:

Objectif général: restaurer les moyens de subsistance des communautés en crise alimentaire.
Objectifs spécifiques:
1) Répondre aux besoins alimentaires d’urgence des populations cibles;
2) Rétablir l’autonomie de production alimentaire pour les familles d’accueil, les ménages nouvellement accessibles et ceux affaiblis par les crises;
3) Soutenir la production alimentaire d’urgence pour des ménages d’enfants malnutris, des personnes déplacées, retournées, rapatriées et autres groupes vulnérables;

Pour cela, les principales activités seront les suivantes:

-Assistance alimentaire d’urgence aux populations en crise pour atténuer les effets immédiats;
-Assistance urgente aux groupes vulnérables (distribution de vivres, non vires et de kits agricoles);
-Réhabilitation urgente des infrastructures de base (pistes et marchés ruraux, vivres contre travail);
-Protection contre la perte complète des avoirs relatifs aux moyens de subsistance et/ou soutien en faveur de l’accès à ces avoirs (vivres contre travail, rations de protection des semences, foires aux semences).

Secteur de l’Eau, hygiène et assainissement: Besoins identifiés:

La vulnérabilité dans les provinces précitées est les théâtres de mouvements perpétuels de population. Avec une telle instabilité, le choléra et les maladies d’origine hydrique peuvent se développer de manière exponentielle pour plusieurs raisons:
• Les déplacements favorisent la dispersion des germes pathogènes;
• Les personnes déplacées créent une pression additionnelle sur les ressources en eau et les infrastructures sanitaires des autochtones, ce qui génère une pénurie et une dégradation précoce des équipements existants;
• Les hôpitaux et Centres de Santé dans les zones d’accueil sont débordés du fait de l’arrivée de nouvelles personnes et sont de ce fait moins capables de répondre aux flambées d’épidémies endémiques;
• Les personnes déplacées sont souvent plus vulnérables aux maladies.

Plan de réponse du Secteur:
Objectif général: réduire les risques de transmission des maladies infectieuses d’origine hydrique sur les populations déplacées et retournées ou victimes d’épidémies et de catastrophes naturelles par des actions de prévention et de réponse d’urgence, ceci pour la sécurité et la dignité des filles, des femmes, des garçons et des hommes.

Objectif spécifique 1: assurer l’accès en eau potable en quantité et en qualité suffisante aux populations affectées dans des conditions de sécurité et de dignité, en consultation avec les communautés locales, en particulier les femmes et des adolescents, pour la désignation de l’emplacement des points de distribution d’eau.

Objectif spécifique 2: assurer l’accès à un environnement sain et protecteur aux populations affectées dans des conditions de sécurité et de dignité par la mise à disposition d’infrastructures d’hygiène et d’assainissement.

Activité 1: construction des latrines collectives différenciées et sécurisées (pour les femmes et les filles), et des latrines familiales. Les latrines collectives visent les communautés ou les lieux publics tels que les écoles, les hôpitaux et les marchés;
Activité 2: construction de douches collectives différenciées et sécurisées.

Par ailleurs, les principaux enjeux en protection des civils dans les provinces affectées par les conflits armés, en particulier dans le Nord, Sud-Kivu , le Tanganyika et en province du Kasaï central, sont liés à l’inaccessibilité et l’enclavement de certaines zones, ce qui favorise les violations graves des droits de l’homme ou du droit international humanitaire par les FARDC et d’autres groupes armés/milices présentes dans ces contrées.

Cette situation, est à l’origine de déplacements massifs des populations, se traduit par des violations de nombreux abus des droits de l’homme. Ceux-ci incluent l’utilisation des enfants (recrutement d’enfant/adolescents dans les groupes et forces armés, exploitation pour le transport de matériel, violences sexuelles); violences sexuelles faites à la femme; administration et justice illégale et/ou parallèle; pillage et taxation illégale, barrières illégales; limites à la liberté de circulation des populations civiles; prises d’otage de civils; attaques à l’encontre de villages; incendies de maisons; occupation de maisons, d’écoles des centre de santé et de villages par les groupes armés; utilisation des biens et des infrastructures civiles; recrutement et travaux forcés des civils et déplacements/retours forcés.

Pari cochet, au vu et au su de tout ce qui se passe en RDC, GLAPD_Africa, asbl, condamne avec une dernière énergie, les exactions, tueries, massacres, viols, pillages et violation répétitive des droits de l’homme, ce qui met en péril la santé de la mère, de l’enfant, du nouveau-né et de l’adolescent, demandons qu’une enquête juste et indépendante soit diligentée pour éclairer cette situation qui prévaut dans les provinces du Nord, Sud-Kivu, Kasaï central et dans le Tanganyika pour que les auteurs de ces exactions ignobles puissent répondre et purgent de leurs actes.

Les fosses communes sont devenues monnaies courantes dont 23 dans le Kasaï, des fosses communes à Maluku/Kinshasa, au Tanganyika, au Sud-Kivu (Kasika, Mwenga, Makobola/Baraka et dans le Nord-Kivu (Beni, Butembo, Lubero, Walikale, Kitchanga, Rutshuru,…). Ces actes ne doivent pas demeurer impunis, car Trop c’est Trop;

Nous déplorons et fustigeons également la mort tragique et inopinée des deux experts des Nations-Unies ainsi que leurs interprètes et motards Congolais qui ont été tués dans le Kasaï central en l’exercice de leurs fonctions, demandons que leurs bourreaux soient punis sévèrement et conformément aux lois de la République et internationales;

La situation socio-économique, politique et sécuritaire de la population en RDC est au bas de l’échelle mondiale, la liberté d’expression et de manifestation publique de la population est piétinée, l’on ne peut lire au quotidien une paupérisation de la population prise en otage et ne sachant pas à quel saint se vouer.

IV. RECOMMANDATIONS

Nous recommandons à l’Etat congolais d’assurer la sécurité de la population et de leurs biens et d’améliorer la situation socio-économique de la population et de traduire en justice les auteurs de violation des droits de l’homme, De restaurer l’autorité de l’Etat sur toute l’étendue du territoire national;

D’améliorer l’espace de la liberté d’expression et de manifestation pacifique publique ainsi que la liberté de presse;

Aux acteurs politiques Congolais de privilégier, le dialogue, la coopération et l’intérêt général de la population en lieu et place de leurs intérêts égoïstes et mesquins;

Aux organisations de la société civile et forces vives de ne pas céder aux intimidations politiciennes et partisanes, de bien jouer leur rôle de neutralité, d’impartialité, de l’indépendance, le principe de Do Not Harm et d’accompagnateur au lieu de se mêler dans les commérages des politiciens;

Au conseil de sécurité des Nations, d’assurer un suivi de proximité sur le nouveau mandat de la MONUSCO, l’application de la résolution 2348 et l’accord de la saint Sylvestre du 31 décembre 2016 et lutte contre les groupes armés et milices et de jouer pleinement leur mandat de la protection des civiles;

A la communauté nationale et internationale de mobiliser les fonds nécessaires pour accompagner la RDC dans le processeur démocratique d’organisation des élections libres et transparentes au financement des différents projets et programmes d’intérêt public et communautaire et s’impliquer dans le processus de la sécurisation de la population civile aux éventuelles violations des droits de l’homme;

Aux organisations humanitaires, caritatives, systèmes des nations-unies, publiques, privées, aux donateurs, aux hommes et femmes de bonne volonté de venir en aide, les populations déplacées de guerre afin de restaurer la santé de la mère, de l’enfant, du nouveau-né et de l’adolescent actuelle a son plus bas niveau et le ramener aux standards internationaux.

Au PMNCH/Partnership for Maternal, Newborn and Child Health  et au mouvement Every Women Every Child/EWEC de nous aider à faire le plaidoyer auprès des donateurs, bailleurs de fonds et décideurs afin de libérerez le fonds nécessaires pour répondre à la situation humanitaire et à la santé de la mère, de l’enfant, du nouveau-né et de l’adolescent en RDC, car le développement de l’Afrique est assujetti par la stabilité permanente de la RDC ainsi pour permettre d’atteindre les ODD à l’horizon de 2030.

Une action humanitaire bien soutenue et avec compassion permet sans ambages à sauver des vies des milieux des Congolais qui sont dans le besoin le plus (surtout chez la femme, l’enfant, le nouveau-né et les adolescents) ainsi promouvoir la santé reproductive.

En définitive, GLAPD_Africa, asbl, reste bras ouverts pour recevoir vos appuis et soutiens éventuels pour aider la RDC de sortir dans l’impasse humanitaire et d’avance droit chemin vers les ODD à l’horizon 2030.

Fait à Kalemie, le 07 avril 2017

Alphonse KITOGA
Secrétaire Général.

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Published under licence from Alphonse Kitoga  © Copyright SOS situation Humanitaire-DRC | Great-Lakes in Action for Peace and the
Sustainable Development / GLAPD_Africa, asbl. Tél: +243 81 78 85 806& + 243 85 53 04
686. E-mail: glapd_africa2002@yahoo.fr & alphonse_kitoga@yahoo.fr