UNDP-led ADP: Working Paper

undpAccess and delivery partnership

A Pipeline Analysis of New Products for Malaria, Tuberculosis and Neglected Tropical Diseases, August 2016

http://adphealth.org/upload/resource/ADP_Pipeline_Analysis_Report.pdf 

Presentation

This report, published by the UNDP-led Access and Delivery Partnership, is a comprehensive survey of the product pipeline for products that show promise in improving current approaches towards the prevention, diagnosis and treatment of malaria, tuberculosis (TB) and neglected tropical diseases (NTDs).

The aim is to identify potential challenges in the introduction of new health products in developing countries. New products may come with requirements for greater safety monitoring, or changes to the procurement and supply systems, as well as affordability considerations. Where relevant information is available, it can contribute to the planning and design of interventions to enable access to such new products for the patients who need them.

This report compiles information on potential new vaccines, diagnostics and medicines for TB, malaria and three NTDs – human African trypanosomiasis (HAT), leishmaniasis and Chagas disease. It is hoped that such analysis of the product pipeline across the product categories of vaccines, diagnostics and medicines can help to highlight common issues or problems, as well as promote better synergies for implementation research. The report is intended as an on-going initiative, to regularly update the information so that policy-makers and other actors have access to key information on new health products.

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The international Good Clinical Practices Code: Time for a Global Approach

The WHO and ICH (International Conference for Harmonization) GCP codes have not been updated since 1995 and 1996 respectively. Currently, a partial revision of the ICH GCP code is ongoing, but the update process does not seem sufficiently inclusive. If GCP codes are meant to set standards pertinent and applicable at global level, then a more comprehensive revision is needed, characterized by more transparency and more inclusiveness together with adequate representation of researchers, sponsors, regulators and ethical reviewers from LMICs

raffaella ravinetto

by Raffaella Ravinetto*

Head of Clinical Trials Unit, Antwerp Institute of Tropical Medicine

The international Good Clinical Practices Code: Time for a Global Approach

 

The Good Clinical Practices (GCP) codes are meant to set globally applicable standards for the conduct of clinical trials on pharmaceutical products on human subjects (1). They are “an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects”. Compliance with GCP “provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible” (2).

There are two international GCP codes: the one of the World Health Organization (WHO) (1) and the one of the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) (2). Despite their similarities, they originate from quite different frameworks. The WHO is an international organization that brings together 194 Member States, and it is mandated to direct and coordinate international health within the United Nations system (http://www.who.int/about/en/). The ICH brings together the regulatory authorities and pharmaceutical industry from the European Union, the United States, Japan, Canada and Switzerland, and it is mandated “to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in the form of the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use” (http://www.ich.org/home.html). Despite its limited mandate, the ICH has the ambition to become a global standard, and today most clinical research actors in Low- and Middle-Income Countries (LMICs) refer to the ICH rather than WHO GCP code. Non-ICH countries are involved in ICH through the Global Cooperation Group, but in practice their contribution seems to be quite limited (3),

Early critics of the ICH GCP code contended that it derived from informal consensus (considered as the weakest approach to guidelines development) and that it was written in absence of a systematic up-to-date search for the relevant literature (4). Others argued that the international GCP codes were “created by a small number of regulatory agencies and drug companies from industrialized nations, with little input from developing countries” (5).  Leading academic researchers also contended that the international GCP codes lack consideration for the challenges met by clinical researchers in LMICs (6, 7). The latter is not surprising. While other guidelines and regulations are subject to periodical revisions, the WHO and ICH GCP codes have not been updated since 1995 and 1996 respectively. Thus, they reflect the situation of more than twenty years ago, when multi-centre clinical trials were mainly conducted in Western contexts, and they do not take into account the challenges met today, in the context of “globalization of clinical trials”, with more and more trials carried out in LMICs (8). Since the international GCP codes guide and orient most national legislators and most funding agencies, their failure to address the challenges of researchers in LMICs may result in insufficient protection of research subjects and communities in these contexts.

We are not aware of any update of WHO GCP. Conversely, a partial revision of the ICH GCP code is ongoing, to modernize it “by supplementing with additional recommendations which will facilitate broad and consistent international implementation of new methodologies” (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf). The fact that the revision was accompanied by an open consultation (till 31st January 2016) surely provided a positive opportunity to try to have an impact. But the update process was poorly known and it does not seem sufficiently inclusive. In practice, it is not clear whether significant inputs came from the non-ICH region, and to what extent they will be taken into account.

If GCP codes are meant to set standards pertinent and applicable at global level, then a more comprehensive revision is needed, characterized by more transparency and more inclusiveness. In particular, adequate representation of researchers, sponsors, regulators and ethical reviewers from LMICs should be ensured. The revised guidelines should be strongly rooted in ethics, be sensitive to the different cultural and social perspectives, and take into account trials- and context-related challenges, for being at the same time “global”, “context centered” and “patient centered”.

This paper derives from a doctoral thesis, “Methodological and ethical challenges in non-commercial North-South collaborative clinical trials”, carried out at KU Leuven (Belgium). The manuscript is available at https://lirias.kuleuven.be/handle/123456789/517274.

References 

1) World Health Organization (WHO). Guidelines for Good Clinical Practices for trials on pharmaceutical products. 1995. WHO Technical Report Series No. 850, Annex 3. Geneva, Switzerland. Last accessed on 14/09/2015 at http://apps.who.int/medicinedocs/pdf/whozip13e/whozip13e.pdf

2) International Conference of Harmonization (ICH). ICH Tripartite Guideline for Good Clinical Practices E6 (R1), 10th June 1996. Last accessed on 14/09/2015 at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf

3) Specht S and Klingmann I. ICH: strenghts, weaknesses, and future tasks. Ther Inn & Reg Science 2014; 48(3):357-61

4) Grimes DA, Hubacher D, Nanda K, Schulz KF, Moher D and Altman DG. The Good Clinical Practice guideline: a bronze standard for clinical research. Lancet 2005; 366(9480):172-4

5) Rennie S. The FDA and Helsinki. Hastings Cent Rep 2009: 39(3):49

6) White NJ. Editorial: Clinical trials in tropical diseases: a politically incorrect view. Trop Med Int Health 2006; 11(10):1483-4

7) Lang T, Cheah P Y and White N J. Clinical research: time for sensible global guidelines. Lancet 2011; 377(9777):1553–5

8) Lang T and Siribaddana S. Clinical trials have gone global: is this a good thing? PLoS Med 2012;  9(6):e1001228

 

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*Raffaella Ravinetto holds a Pharmacy Degree from the University of Torino and a Postgraduate Diploma in Tropical Medicine from the Antwerp Institute of Tropical Medicine.   

After a seven-year experience as a Clinical Research Scientist in the private pharmaceutical sector, she worked in emergency and development programs in the Balkans and in Africa. In 2002, she joined Médecins Sans Frontières (MSF), where she followed various dossiers on access to essential medicines and quality of medicines, while performing regular field assessments. She currently works at the Antwerp Institute of Tropical Medicine, as head of the Clinical Trials Unit, coordinator of the Switching the Poles Clinical Research Network and promoter of Quamed (a Network promoting evidence-based strategies for universal access to quality medicines). She was president of the Italian branch of MSF (2007-2011).   

Her main areas of interest include North-South collaborative clinical research, research ethics (particularly in relation to resource-constrained settings) and access to health. 

 

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Streamlining R&D Core Areas for Global Health Reporting

While complex R&D reporting frameworks, including the one suggested by COHRED’s Research Fairness Initiative, are commendable and exhaustive, streamlined models should be looked for in order to enhance confidence, overcome reluctance, and make the reporting practice actually an easy task

MINOLTA DIGITAL CAMERA

by Daniele Dionisio*

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

Streamlining R&D Core Areas for Global Health Reporting

 

As recently pointed out, …Partnerships are essential to deliver research and innovation for global health and development. Sustainable Development Goal 17 emphasizes that all the other Sustainable Development Goals rely on partnerships for their achievement. Yet, there is no agreed framework, benchmark, or standard of best practice on which to model governmental, corporate, non-profit, or academic partnerships – particularly not considering ‘fairness’ of international research collaborations to partners in low- and middle-income countries….

To fill these gaps, a reporting system is needed most with a focus on what interested parties really do to increase the fairness of research partnerships they are involved in.

While complex reporting frameworks, including the one suggested by COHRED’s Research Fairness Initiative, are commendable and exhaustive, streamlined models should be looked for in order to enhance confidence, overcome reluctance, and make the reporting practice actually an easy task.

Bearing this in mind, a minimum, not to be given up data collection should arise from essential core questions. In my opinion, they should align with philosophy and the field approach DNDi Charity has been successfully pursuing since the last decade.

As such, essential areas for reporting should entail answering a small set of questions as below:

How has the organisation/partnership managed to break the link between the cost of R&D and the price of products and ensure that the fruits of innovation are accessible at the lowest possible price for patients?

How has the organisation/partnership managed to integrate global health R&D monitoring, coordination and financing?

Based on fully affordable new medicines rolled-out by DNDI over ten years, DNDI’s cost estimates should be taken into account. As the Charity reports: “..DNDi’s cost of development ranges from EUR 6-20 million for an improved treatment, and EUR 30-40 million for a new chemical entity. However, the usual attrition in the field of R&D for infectious diseases, and the inherent risk of failure, should be taken into account, bringing the cost range of an improved treatment to EUR 10-40 million, and EUR 100-150 million for a new chemical entity”.

Report on cost details relevant to service providers and partners

The costs of activities externalized to service providers should be made explicit in full. Partners, as per DNDi words, bring specific value to the projects under different forms:  Free access to their assets (e.g. compound libraries); In-kind contributions (expertise, including from independent/ retired experts; active pharmaceutical ingredient (API) or manufactured products for trials; delivery/funding of R&D process, e.g. pharmacokinetic/pharmacodynamics studies; registration) Operational role in downstream processes (manufacturing, distribution) as ‘implementation partner’.

How has the WHO’s Prequalification Programme been involved as a guide for national regulatory authorities in low –and middle income countries with weak regulatory capacity?

How and to what extent has the organisation/partnership been routed in open models for innovation?

How has the organisation/partnership managed to ensure that the partnership outputs are placed and remain in the public domain?

Do the licensing terms of partnership research outputs explicitly guarantee equitable and affordable access to treatments based on ■Perpetual royalty-free, nonexclusive, sub-licensable licenses in the specific disease areas determined in the contract; ■Worldwide research and manufacturing rights; ■Commitment to make the final product available at cost, plus a minimal margin, in all endemic countries, regardless of their income level; ■Non-exclusivity, enabling technology transfer and local production to multiply sources of production and decrease cost of product?

How has the organisation/partnership assured licensing terms (including access to knowledge and data) whereby the research itself and the outputs of research are considered public goods?

Has the research knowledge been timely published in open access journals and publicly accessed databases?

As a guarantee of patient-centricity in decision-making: how has the organisation/partnership involved patient representatives and field practitioners?

To what extent has the organisation/partnership involved authorities and partners in neglected-disease endemic countries to help define priorities and facilitate implementation of new tools?

How has the organisation/partnership secured alliances with pharma/biotech companies and academia through innovative IP licensing to access sources of knowledge in order to identify potential new compounds and ultimately reduce the cost of development?

How has the organisation/partnership maintained a balance of public and private support to minimize as much as possible earmarked donations and ensure that no one donor contributes more than 25% of the overall budget?

How has the organisation/partnership diversified funding to prevent unhealthy influence by, or dependence upon, any single donor?

 

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*Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. Dionisio is former director of the Infectious Disease Division at the Pistoia City Hospital (Italy), and Head of the research project PEAH – Policies for Equitable Access to Health.

d.dionisio@tiscali.it  http://www.peah.it/  https://twitter.com/DanieleDionisio

 

HIV Serodiscordant Couples: They Want to Have Children but Can They?

HIV-infected women in serodiscordant partnerships in African countries experience relationship stress due to low socioeconomic status, gender-related power dynamics and pressure to have children with their current partner to ‘bind’ the relationship. These stressors may influence ART adherence. As biomedical interventions (ART, PrEP, VMMC) are scaled up, couple-focused interventions including shared decision making, risk-reduction counseling, mutual adherence support, safer conception and economic empowerment could improve relationship and treatment outcomes in serodiscordant partnerships  

Junior Bazile

by Junior Bazile MD, MPH

Moderator of the HIV Treatment and Prevention Community on Global Health Delivery Online

Global Health Delivery Project at Harvard University

HIV Serodiscordant Couples: They Want to Have Children but Can They?

How to Manage Programs with HIV Serodiscordant Couples

 

It is a fact that in all HIV/AIDS programs there is need for appropriate counseling, psychosocial support and management of the HIV serodiscordant couples.

Biologically and immunologically there have been many explanations on why the partner of an HIV positive patient would not get infected even if the two have sexual intercourses without condoms. There have been explanations offered about the existence of the Natural Killer (NK) cells that would offer a certain immunity to the seronegative partner and more recently it has been discovered that a mutation in the CCR5 receptors, which are the receptors of predilection for HIV, can confer a certain immunity against HIV to the seronegative partner.

Beyond the biological and immunological concepts, one thing remains true: the serodiscordant couples want to have sex (and ideally without condoms), and they want to have children despite the fact that nurses and doctors have been encouraging them to use condoms every time that they are having sex.

There are a few ways that we can help them to have a safe conception.

HIV viral load of the positive partner plays a key role. As long as the HIV viral load is undetectable, the risk of transmission to uninfected partner is greatly reduced. In addition, there is a role of pre-exposure prophylaxis (PreP)

Contrary to common belief, serodiscordant couples often stay together, especially if they have children, with a median duration of partnership of 7 years (range, 3-14) [1] Although there have been concerns that intimate partner violence (IPV) could be prevalent in HIV-1 serodiscordant couples, their frequency of IPV is similar to the general population [1].

Fertility intentions are common in serodiscordant couples – 36% of HIV-1 infected women and 28% of HIV-1 infected men [2]. Not surprisingly, pregnancy rates in Africa are high; pregnancy incidence was 15.3 per 100 person-years in HIV-1 uninfected women and 16.0 per 100 person-years in HIV-1 infected women [3].

Couples with HIV-1 uninfected women can practice non-intercourse insemination. However, sperm washing and intrauterine insemination are not available for the majority of couples with HIV-1 uninfected women. With the advent of ART and PrEP for HIV-1 prevention, options for serodiscordant couples desiring safer conception include:

a) Delay trying to conceive until the HIV-1 infected partner has achieved complete viral suppression.

b) Daily oral Truvada pre-exposure prophylaxis for the HIV-1 uninfected woman until she conceives.

c) Limit sex without condoms to peak fertility periods

d) Treatment for sexually transmitted infections

e) Circumcision for HIV-1 uninfected male partners

The couple should be reminded that the efficacy of antiretroviral-based HIV-1 prevention is dependent on their medication adherence [4].

Although genetic factors may influence HIV-1 transmission risk (32-base pair deletion in chemokine receptor 5, haplotype HLA-DRB1*1301), these appear to occur in a minority of individuals. The main risk factor for sexual transmission is plasma and genital viral load in the HIV-1 infected partner[4].

Cultural factors certainly influence uptake of HIV-1 prevention interventions. For example, use of traditional herbal medicine alongside ART is not uncommon. In addition, scale-up of voluntary medical male circumcision (VMMC) in non-circumcising communities can be challenging. However, high-level community advocacy helped increase uptake of VMMC in Western Kenya. Between 2008 and 2013, 792,931 boys and men were circumcised (92% of the target number). Male circumcision prevalence in Nyanza increased from 45% in 2007 to 66% in 2012 [5].

The issue of serodiscordance can be a complex one for both health professionals and patients. Health providers offering HIV test, nurses, doctors who are interacting with the serodiscordant couples need to be trained in couple counseling. As we all know, talking about HIV to one individual can be complicated let alone talking to two individuals who are either married or living in common law where only one of them is infected. When considering the tons of questions and worries that the negative partner might have it can feel overwhelming.

It seems that social support, health education for patients and the whole community at large are really key to ensure that discordant couples understand their situations, understand each other, support each other and make the best decisions when it comes to conceive a baby.

Even before considering any decision about conception the couples should ensure that viral suppression is completed, circumcision for male seronegative should be emphasized, pre-exposure prophylaxis should be practiced regularly, treatment of any STI and condom use during fertile periods should be encouraged.

Nowadays pre-exposure prophylaxis is more and more available even in the resource-limited settings. However, in the resource-limited settings, patients should be educated and particularly they should be made aware of the existence of such services. In counseling sessions, those points must be clearly explained to the couples and the counselors should ensure that the couples understand each of the points. We need to point out that for some patients issues related to condom, pre-exposure prophylaxis and even circumcision might not be easily digested.

While we typically see patients in individual consultations, ideally HIV care and treatment services should discuss fertility and childbearing jointly with female and male partners. There are several distinct advantages to a couple-based approach. First, because partnerships have an important influence on fertility decisions, consulting with couples can be useful in helping individuals and their partners arrive at appropriate informed decisions about fertility. Second, the health of both partners is important towards safe conception and pregnancy, and delivering care to both partners may therefore be necessary. Third, if a couple is struggling to conceive, there are specific investigations and interventions for both women and men, and investigating and treating one partner only may lead to suboptimal outcomes. However, this entails disclosure of HIV status between partners, which can be a major challenge. At the minimum, the HIV status of both partners must be known and disclosed in order to manage this process safely and effectively.

Despite the importance of a couple-based approach, there are circumstances where an individual desires a child but does not know the serostatus of the partner, or desires a child in the absence of a regular partner or a partner who is willing or able to attend the clinic. These situations present particular challenges.

HIV-infected women in serodiscordant partnerships are at high risk of abandonment, partnership dissolution, and economic hardship. Prior work in Uganda found that partnership dissolution was 3 times as likely in female-positive/male-negative couples than HIV-uninfected couples. Notably, female-negative/male-positive couples were not more likely to divorce or separate than HIV-uninfected couples, suggesting HIV-infection in women was significantly associated with relationship dissolution [6].

In Nairobi, Kenya, 469 serodiscordant couples, 64% of which had HIV-1 infected women partners, were followed between 2007 and 2009. Incidence of partnership dissolution was high – 16.6 per 100 couple-years. Of the 85 subjects who reported separation or divorce, 45 (53%) cited HIV discordance as the main reason [7]. Not having children in the partnership, being unmarried and low socioeconomic status predicted partnership dissolution. Among couples without an income, female-positive/male-negative couples were 5 times as likely to separate as male-positive/female-negative couples.

HIV-infected women in serodiscordant partnerships experience relationship stress due to low socioeconomic status, gender-related power dynamics and pressure to have children with their current partner to ‘bind’ the relationship. These stressors may influence ART adherence. As biomedical interventions (ART, PrEP, VMMC) are scaled up, couple-focused interventions including shared decision making, risk-reduction counseling, mutual adherence support, safer conception and economic empowerment could improve relationship and treatment outcomes in serodiscordant partnerships.

 

References

[1] Mujugira A, Baeten JM, Donnell D, Ndase P, Mugo NR, Barnes L, et al. Characteristics of HIV-1 Serodiscordant Couples Enrolled in a Clinical Trial of Antiretroviral Pre-Exposure Prophylaxis for HIV-1 Prevention. PLoS ONE. 2011   6(10): e25828.

[2] Murnane PM, Celum C, Mugo Nelly et al. Efficacy of pre-exposure prophylaxis for HIV-1 prevention among high-risk heterosexuals: subgroup analyses from a randomized trial. AIDS 2013, 27:2155–2160

[3] Mugo NR, Heffron R, Donnell D et al. Increased Risk of HIV-1 Transmission in Pregnancy: A Prospective Study among African HIV-1 Serodiscordant Couples. AIDS 2011, 25 (15): 1887-1895

[4] Matthews LT, Smit JA, Cu-Uvin S, Cohan D. Antiretroviral and safer conception for HIV serodiscordant couples. Curr Opin HIV AIDS. 2012, 7(6) 569-578

[5] Kenya AIDS Indicator Survey 2015

[6] Porter L, Hao L, Bishai D, et al. HIV status and union dissolution in sub-Saharan Africa: the case of Rakai, Uganda. Demography  2004, 41: 465–482

[7] Mackelprang RD, Bosire R, Guthrie BL et al. High Rates of Relationship Dissolution Among Heterosexual HIV-Serodiscordant Couples in Kenya. AIDS Behav. 2014, 18(1): 189-193